Niraparib Clinical Trials (2026): 199 Studies for Ovarian Cancer & Ovarian Neoplasms
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
199 Niraparib clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 106 indications (including Ovarian Cancer & Ovarian Neoplasms) and 34,502 total planned enrollment. 18 Phase 3 Niraparib trials and 100 Phase 2, 5 Phase 4 are listed. 39 Niraparib clinical trials are actively recruiting at 94 U.S. sites across 30 states. Most recent activity: NCT06915025 (Oct 2032).
Where to Participate: All Niraparib Trial Sites in the U.S. (94 sites across 30 states)
Every actively recruiting Niraparibtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AL | University of Alabama at Birmingham | Birmingham35294 | NCT01042379 | Map |
| AL | University of Alabama at Birmingham | Birmingham35233 | NCT06388733 | Map |
| AZ | Ivy Brain Tumor Center | Phoenix85013 | NCT06388733 | Map |
| CA | University of California - Davis, Comprehensive Cancer Center | Davis95817 | NCT01042379 | Map |
| CA | City of Hope | Duarte91010 | NCT01042379 | Map |
| CA | GSK Investigational Site | Encinitas92024 | NCT04641247 | Map |
| CA | Moores UCSD Cancer Center | La Jolla92093 | NCT06388733 | Map |
| CA | Scripps Cancer Center | La Jolla92037 | NCT06388733 | Map |
| CA | University of California San Diego | La Jolla92093-0698 | NCT01042379 | Map |
| CA | GSK Investigational Site | Los Angeles90048 | NCT04641247 | Map |
| CA | University of Southern California | Los Angeles90033 | NCT01042379 | Map |
| CA | HOAG Memorial Hospital Presbyterian | Newport Beach92663 | NCT01042379 | Map |
| CA | University of California Davis | Sacramento95817 | NCT04812366 | Map |
| CA | University of California San Francisco (UCSF) | San Francisco94115 | NCT01042379 | Map |
| CA | University of California, San Francisco | San Francisco94143 | NCT05694715 | Map |
| CO | University of Colorado Cancer Center | Aurora80045 | NCT01042379 | Map |
| CT | Smilow Cancer Hospital at Yale New Haven | Guilford06437 | NCT06388733 | Map |
| CT | Yale Cancer Center | New Haven06510 | NCT01042379 | Map |
| DC | Georgetown University Medical Center | Washington D.C.20007 | NCT01042379 | Map |
| FL | Broward Health | Fort Lauderdale33316 | NCT06412120 | Map |
| FL | University of Florida Jacksonville | Jacksonville32209 | NCT06412120 | Map |
| FL | University of Miami | Miami33136 | NCT06412120 | Map |
| FL | Advent Health | Orlando32804 | NCT06915025 | Map |
| FL | H. Lee Moffitt Cancer Center and Research Institute | Tampa33612 | NCT01042379 | Map |
| FL | Moffitt Cancer Center | Tampa33612 | NCT05526989 | Map |
| FL | Moffitt Cancer Center | Tampa33612 | NCT01042379 | Map |
| GA | GSK Investigational Site | Atlanta30342 | NCT04641247 | Map |
| GA | Winship Cancer Institute of Emory University | Atlanta30322 | NCT01042379 | Map |
| IL | University of Chicago | Chicago60453 | NCT01042379 | Map |
| IL | GSK Investigational Site | Harvey60426 | NCT04641247 | Map |
| IL | Loyola University | Maywood60153 | NCT01042379 | Map |
| IN | Indiana University | Indianapolis46202 | NCT06388733 | Map |
| LA | The NeuroMedical Center | Baton Rouge70809 | NCT06388733 | Map |
| ME | MaineHealth Maine Medical Center Care | South Portland04106 | NCT06388733 | Map |
| MA | Brigham & Women's Hospital | Boston02115 | NCT04812366 | Map |
| MA | GSK Investigational Site | Boston02115 | NCT04641247 | Map |
| MA | Tufts Medical Center | Boston02111 | NCT06388733 | Map |
| MI | University of Michigan Health | Ann Arbor48109-5946 | NCT04812366 | Map |
| MI | University of Michigan Rogel Cancer Center | Ann Arbor48109 | NCT06388733 | Map |
| MI | GSK Investigational Site | Grand Rapids60637-1470 | NCT04641247 | Map |
| MI | Herbert-Herman Cancer Center, Sparrow Hospital | Lansing48912 | NCT01042379 | Map |
| MN | Allina Health | Minneapolis55407 | NCT06388733 | Map |
| MN | University of Minnesota | Minneapolis55455 | NCT01042379 | Map |
| MN | University of Minnesota Health Clinics and Surgery Center, Minneapolis | Minneapolis55455 | NCT06388733 | Map |
| MN | Mayo Clinic | Rochester55905 | NCT01042379 | Map |
| MN | Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center | Saint Louis Park55416 | NCT01042379 | Map |
| MO | Saint Lukes Neuro Oncology | Kansas City64111 | NCT06388733 | Map |
| MO | Washington University School of Medicine in St. Louis | St Louis63110 | NCT06915025 | Map |
| MO | Washington University, School of Medicine | St Louis63110 | NCT06388733 | Map |
| NJ | GSK Investigational Site | Morristown07962-1956 | NCT04641247 | Map |
| NJ | Jersey Shore University Medical Center | Neptune City07753 | NCT06388733 | Map |
| NJ | Rutgers Cancer Institute of New Jersey | New Brunswick08903 | NCT01042379 | Map |
| NJ | Atlantic Health System | Summit07901 | NCT06388733 | Map |
| NY | Roswell Park Cancer Institute | Buffalo14263 | NCT01042379 | Map |
| NY | GSK Investigational Site | Lake Success11042 | NCT04641247 | Map |
| NY | Northwell Health | New Hyde Park11042 | NCT06388733 | Map |
| NY | Columbia University Medical Center | New York10032 | NCT01042379 | Map |
| NY | Laura and Isaac Perlmutter Cancer Center / NYU Langone Health | New York10016 | NCT01042379 | Map |
| NY | New York University Ambulatory Care Center | New York10016 | NCT06388733 | Map |
| NY | University of Rochester Wilmot Cancer Institute | Rochester14642 | NCT01042379 | Map |
| NY | Montefiore Medical Center | The Bronx10467 | NCT01042379 | Map |
| NY | Montefiore Medical Center | The Bronx10461 | NCT06388733 | Map |
| NC | GSK Investigational Site | Charlotte28204 | NCT04641247 | Map |
| NC | Duke Cancer Center Brain Tumor Clinic | Durham27710 | NCT06388733 | Map |
| NC | Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem27157 | NCT01042379 | Map |
| NC | Wake Forest Baptist Health | Winston-Salem27157 | NCT06388733 | Map |
| OH | University of Cincinnati Cancer Institute | Cincinnati45267 | NCT06388733 | Map |
| OH | Cleveland Clinic | Cleveland44106 | NCT01042379 | Map |
| OH | The Cleveland Clinic Foundation | Cleveland44195 | NCT06388733 | Map |
| OH | The Ohio State University | Columbus43210 | NCT06388733 | Map |
| OH | The Ohio State University, Stefanie Spielman Comprehensive Breast Center | Columbus43212 | NCT01042379 | Map |
| OR | Oregon Health & Science Institute (OHSU) | Portland97239 | NCT01042379 | Map |
| OR | Providence Cancer Institute | Portland97213 | NCT06915025 | Map |
| OR | Providence Portland Medical Center | Portland97213 | NCT06388733 | Map |
| PA | Thomas Jefferson University | Philadelphia19107 | NCT06388733 | Map |
| PA | University of Pennsylvania (U Penn) | Philadelphia19104 | NCT01042379 | Map |
| PA | University of Pennsylvania, Abramson Cancer Center | Philadelphia19104 | NCT06747845 | Map |
| PA | University of Pittsburgh Medical Center Health System | Pittsburgh15232 | NCT06388733 | Map |
| SC | Medical University of South Carolina - Department of Neurosurgery | Charleston29425 | NCT06388733 | Map |
| SD | Sanford Clinical Research | Sioux Falls57104 | NCT01042379 | Map |
| SD | Sanford Health | Sioux Falls57104 | NCT06915025 | Map |
| TN | Erlanger Health | Chattanooga37403 | NCT06915025 | Map |
| TX | M D Anderson Cancer Center | Houston77030 | NCT04947254 | Map |
| TX | M D Anderson Cancer Center | Houston77030 | NCT05700721 | Map |
| TX | MD Anderson Cancer Center | Houston77030 | NCT05526989 | Map |
| TX | U.T. MD Anderson Cancer Center | Houston77030 | NCT04812366 | Map |
| TX | Baylor Scott & White Health | Temple76508 | NCT06388733 | Map |
| UT | Huntsman Cancer Institute, University of Utah | Salt Lake City84112 | NCT01042379 | Map |
| VT | The University of Vermont Medical Center | Burlington05401 | NCT06388733 | Map |
| WA | Fred Hutchinson Cancer Center | Seattle98109 | NCT04812366 | Map |
| WA | University of Washington Medical Center | Seattle98109 | NCT06388733 | Map |
| WA | Providence Sacred Heart Medical Center & Children's Hospital | Spokane99204 | NCT06915025 | Map |
| WI | University of Wisconsin Cancer Center | Madison53706 | NCT06388733 | Map |
| WI | Froedtert and The Medical College of Wisconsin | Milwaukee53226 | NCT06915025 | Map |
Niraparib clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | withdrawn | not yet recruiting | unknown | approved for marketing | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early P1 | 2 | 2 | 4 | ||||||
| P1 | 1 | 6 | 16 | 5 | 4 | 3 | 35 | ||
| P1/P2 | 3 | 5 | 7 | 2 | 3 | 2 | 1 | 23 | |
| P2 | 20 | 17 | 23 | 11 | 7 | 2 | 20 | 100 | |
| P2/P3 | 1 | 1 | 2 | ||||||
| P3 | 5 | 7 | 3 | 1 | 1 | 1 | 18 | ||
| P4 | 1 | 1 | 1 | 1 | 1 | 5 | |||
| N/A | 2 | 6 | 1 | 1 | 2 | 12 |
Recruiting Niraparib clinical trials (39)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06915025 | OVATION-3Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer | P3 | Epithelial Ovarian Cancer | 500 | Jul 2025 |
| NCT05183984 | NIRVANA-1Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer | P2 | Ovarian Cancer | 390 | Feb 2022 |
| NCT05009082 | Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer | P3 | Ovarian Cancer | 970 | Sep 2022 |
| NCT01042379 | I-SPYI-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | P2 | Breast Neoplasms | 5,000 | Mar 2010 |
| NCT06412120 | Study Evaluating Safety, Tolerability, and Metabolism of Niraparib | P4 | Ovarian Cancer | 70 | Aug 2026 |
| NCT05232006 | PALB2-PARPi-01PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers | P2 | Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers | 12 | May 2022 |
| NCT04341181 | ProTargetProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling | P2 | Cancer | 300 | Aug 2020 |
| NCT05700721 | STARLETPhase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) | P2 | Brain Metastases | 120 | Jun 2023 |
| NCT06953323 | A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors | P1/P2 | Advanced Solid Tumor | 86 | Jul 2025 |
| NCT06682780 | A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours | P1/P2 | Advanced Solid Tumor | 320 | Sep 2025 |
| NCT03651206 | ROCSANRecurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib | P2/P3 | Ovarian Carcinosarcoma | 138 | Jul 2020 |
| NCT06747845 | ParpVax2Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy | P2 | Pancreatic Adenocarcinoma Metastatic | 68 | May 2025 |
| NCT04423185 | PLATFORM Study of Precision Medicine for Rare Tumors | P2 | Rare Tumor | 770 | Aug 2020 |
| NCT05615818 | SAFIR-ABC10Personalized Medicine for Advanced Biliary Cancer Patients | P3 | Biliary Tract Neoplasms | 800 | Jul 2024 |
| NCT05601440 | Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer | P2 | Breast Cancer | 484 | Jun 2023 |
| NCT04681469 | PRIMEInduction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC | P2 | Head and Neck Squamous Cell Carcinoma | 49 | Feb 2021 |
| NCT07059676 | LIBINI-1Design and Validation of Plasma Proteins and Cytokine Panels to Identify Markers Associated With Response to Niraparib as Maintenance Treatment After First-line Platinum-based Regimen in Patients With Advanced Ovarian Cancer | — | Advanced Ovarian Cancer | 120 | Jul 2025 |
| NCT06388733 | A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma | P3 | Glioblastoma | 450 | Jun 2024 |
| NCT06180356 | ANALLISANiraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression | P2 | Ovarian Cancer | 30 | Dec 2024 |
| NCT05694715 | Combination Therapy in Cancers With Mutations in DNA Repair Genes | P1 | Metastatic Solid Tumor | 24 | May 2023 |
| NCT05519670 | CAPRICEA Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr | P1/P2 | Breast Cancer | 72 | Mar 2023 |
| NCT02925234 | DRUPThe Drug Rediscovery Protocol (DRUP Trial) | P2 | Cancer | 1,550 | Aug 2016 |
| NCT05526989 | Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma | P2 | Penile Carcinoma | 25 | Dec 2022 |
| NCT06258018 | ONC-2022-001Niraparib and Temozolomide in Patients Glioblastoma | P1/P2 | Glioma, Malignant | 86 | Sep 2024 |
| NCT06141265 | BRANDNiraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab | P2 | Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma | 116 | Nov 2023 |
| NCT05961124 | Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer | P2 | Ovarian Cancer | 40 | Aug 2023 |
| NCT06594679 | NICHOLA Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL) | P1/P2 | Ovarian Cancer | 73 | Sep 2024 |
| NCT05990192 | SOPRANOSBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy | P2 | Ovarian Cancer Recurrent | 42 | Jun 2024 |
| NCT06237205 | Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency | P2 | Efficacy | 33 | Feb 2024 |
| NCT05718323 | RAISENiraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC | P2 | SCLC,Extensive Stage | 44 | Dec 2023 |
| NCT04716686 | Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma | P2 | Endometrial Carcinoma | 83 | Jun 2021 |
| NCT03983226 | Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial) | P2 | Ovarian Cancer Recurrent | 167 | Oct 2019 |
| NCT03903835 | ProBioProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer | P3 | Metastatic Castration-resistant Prostate Cancer (mCRPC) | 750 | Feb 2019 |
| NCT04641247 | A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study | P2 | Ovarian Neoplasms | 30 | Apr 2021 |
| NCT06887933 | A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer | P4 | Ovarian Neoplasms | 67 | Apr 2025 |
| NCT04947254 | Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer | P2 | Prostate Carcinoma | 200 | Aug 2021 |
| NCT04812366 | GUNSGenomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer | P2 | Prostate Cancer | 315 | Sep 2021 |
| NCT06614790 | NIRAPARIBNiraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study. | — | Ovarian Cancer | 300 | Sep 2024 |
| NCT06827353 | OVNI-BNiraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency | — | Ovarian Carcinoma | 300 | Oct 2020 |
Niraparib clinical trials by indication
Ovarian Cancer (29)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05183984 | NIRVANA-1 | P2 | recruiting | Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer |
| NCT05009082 | — | P3 | recruiting | Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer |
| NCT06412120 | — | P4 | recruiting | Study Evaluating Safety, Tolerability, and Metabolism of Niraparib |
| NCT06161493 | — | P1 | withdrawn | ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors |
| NCT06180356 | ANALLISA | P2 | recruiting | Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression |
| NCT05961124 | — | P2 | recruiting | Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer |
| NCT06594679 | NICHOL | P1/P2 | recruiting | A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL) |
| NCT04507841 | — | P2 | active not recruiting | Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer |
| + 21 more, see All trials below. | ||||
Ovarian Neoplasms (13)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03602859 | FIRST | P3 | active not recruiting | A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer |
| NCT04641247 | — | P2 | recruiting | A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study |
| NCT06887933 | — | P4 | not yet recruiting | A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer |
| NCT02655016 | GSK3985771 | P3 | active not recruiting | A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy |
| NCT06964165 | COHORT-C | P2 | terminated | A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C) |
| NCT03574779 | OPAL | P2 | completed | A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer |
| NCT03326193 | — | P2 | completed | A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy |
| NCT05734911 | — | N/A | completed | Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study |
| + 5 more, see All trials below. | ||||
Neoplasms (7)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03981796 | RUBY | P3 | active not recruiting | A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer |
| NCT06077877 | PK | P1/P2 | active not recruiting | A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors |
| NCT04544995 | SCOOP | P1 | terminated | Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP) |
| NCT03307785 | — | P1 | completed | Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 |
| NCT03329001 | — | P1 | completed | Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule |
| NCT02657889 | TOPACIO | P1/P2 | completed | Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer |
| NCT03308942 | PD-1 | P2 | completed | Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants |
Breast Cancer (7)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04837209 | NADiR | P2 | active not recruiting | Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer |
| NCT05601440 | — | P2 | recruiting | Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer |
| NCT05519670 | CAPRICE | P1/P2 | not yet recruiting | A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr |
| NCT04762901 | — | P1 | withdrawn | LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer |
| NCT04240106 | LUZERN | P2 | completed | Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN) |
| NCT03154281 | — | P1 | completed | Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast |
| NCT02826512 | — | P2 | terminated | A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients |
Epithelial Ovarian Cancer (6)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06915025 | OVATION-3 | P3 | recruiting | Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer |
| NCT05187208 | POLO | P4 | unknown | PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer |
| NCT04986371 | RENI-1 | N/A | unknown | Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer |
| NCT05385068 | t | P2 | unknown | A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi |
| NCT06086665 | REFIRM | N/A | completed | The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer |
| NCT04546373 | — | N/A | completed | Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer |
Cancer (5)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04341181 | ProTarget | P2 | recruiting | ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling |
| NCT03768063 | IMbrella B | P3 | active not recruiting | A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study |
| NCT02925234 | DRUP | P2 | recruiting | The Drug Rediscovery Protocol (DRUP Trial) |
| NCT04774406 | — | N/A | completed | Arterial Hypertension Related to PARP Inhibitors (ArteRIB) |
| NCT02476552 | — | P1 | completed | Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer |
Advanced Solid Tumor (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06953323 | — | P1/P2 | recruiting | A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors |
| NCT06682780 | — | P1/P2 | recruiting | A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours |
| NCT04502602 | iNNOVATE | P1 | active not recruiting | Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer |
| NCT04655183 | — | P1/P2 | withdrawn | Study of M4344 in Combination With Niraparib |
Prostate Cancer (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06212583 | KNIGHTS | P2 | active not recruiting | High-Risk Metachronous Oligometastatic Prostate Cancer Trial |
| NCT04194554 | ASCLEPIuS | P1/P2 | active not recruiting | A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer |
| NCT06527690 | REPRESENTATION | P2 | withdrawn | Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer |
| NCT04812366 | GUNS | P2 | recruiting | Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer |
Ovarian Cancer Recurrent (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05990192 | SOPRANO | P2 | recruiting | SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy |
| NCT04149145 | PARP | P1 | withdrawn | Trial of M4344 and Niraparib in Patients With Poly (ADP-ribose) Polymerase (PARP) Resistant Recurrent Ovarian Cancer |
| NCT03983226 | — | P2 | recruiting | Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial) |
Glioblastoma (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06388733 | — | P3 | recruiting | A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma |
| NCT05076513 | — | Early P1 | active not recruiting | Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma |
| NCT04221503 | — | P2 | active not recruiting | Niraparib/TTFields in GBM |
Endometrial Cancer (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05289648 | NIREC | Early P1 | withdrawn | Niraparib in High-grade Endometrial Cancer Trial |
| NCT03016338 | — | P2 | unknown | Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer |
| NCT04080284 | — | P2 | completed | Trial of Maintenance With Niraparib- Uterine Serous Carcinoma |
Recurrent Ovarian Cancer (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05335993 | — | P2 | active not recruiting | A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer. |
| NCT05126342 | — | P2 | withdrawn | Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi |
| NCT03025867 | — | N/A | approved for marketing | Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer |
Recurrent Glioblastoma (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05297864 | OU-SCC-PI-4G | P2 | terminated | PARP Inhibition for Gliomas (PI-4G or π4g) |
| NCT05666349 | RiNG | P1 | withdrawn | Reirradiation and Niraparib in Patients With Recurrent Glioblastoma |
| NCT04715620 | — | P2 | unknown | Niraparib Combined With Radiotherapy in rGBM |
Solid Tumor (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04185831 | MEGALiT | P2 | active not recruiting | A MolEcularly Guided Anti-Cancer Drug Off-Label Trial |
| NCT05169437 | PAVO | P2 | terminated | Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors |
| NCT04235101 | — | P1 | completed | Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors |
Neoplasms, Breast (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04915755 | ZEST | P3 | active not recruiting | Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease |
| NCT01905592 | BRAVO | P3 | terminated | A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients |
| NCT03329937 | — | P1 | completed | Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer |
Prostatic Neoplasms (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04577833 | AA | P1 | active not recruiting | A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer |
| NCT02854436 | Galahad | P2 | completed | An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies |
| NCT02924766 | BEDIVERE | P1 | completed | A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) |
Pancreatic Cancer (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03601923 | — | P2 | completed | Niraparib in Patients With Pancreatic Cancer |
| NCT03553004 | NIRA-PANC | P2 | unknown | Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial |
| NCT04409002 | — | P2 | completed | Niraparib + Dostarlimab + RT in Pancreatic Cancer |
Metastatic Prostate Cancer (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06329830 | LUNAAR | P1/P2 | withdrawn | 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer |
| NCT02500901 | CRPC | P1 | terminated | Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) |
Head and Neck Squamous Cell Carcinoma (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05784012 | RADIAN | P1/P2 | active not recruiting | Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma |
| NCT04681469 | PRIME | P2 | recruiting | Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC |
Mesothelioma, Malignant (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05455424 | NERO | P2 | completed | Niraparib Efficacy in Patient With Unresectable Mesothelioma |
| NCT03654833 | MiST | P2 | unknown | Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma |
Ovarian Carcinoma (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06827353 | OVNI-B | N/A | recruiting | Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency |
| NCT05311579 | — | P2 | unknown | Niraparib Plus Anlotinib for Recurrent Ovarian Cancer |
Endometrial Carcinoma (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04716686 | — | P2 | recruiting | Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma |
| NCT04159155 | CAN-STAMP | P2/P3 | terminated | A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer |
Lung Cancer (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04940637 | UNITO-001 | P2 | unknown | UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC |
| NCT03891615 | — | P1 | unknown | Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer |
Prostate Adenocarcinoma (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04037254 | — | P1/P2 | completed | Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring |
| NCT04288687 | — | P2 | completed | A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects |
Urothelial Carcinoma (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03869190 | MORPHEUS-UC | P1/P2 | completed | Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) |
| NCT03945084 | — | P2 | completed | Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy |
Metastatic Hormone-sensitive Prostate Cancer (mHSPC) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06392841 | HARMONY | P2 | withdrawn | Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations |
Advanced Ovarian Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07059676 | LIBINI-1 | N/A | not yet recruiting | Design and Validation of Plasma Proteins and Cytokine Panels to Identify Markers Associated With Response to Niraparib as Maintenance Treatment After First-line Platinum-based Regimen in Patients With Advanced Ovarian Cancer |
Pancreatic Adenocarcinoma Metastatic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06747845 | ParpVax2 | P2 | recruiting | Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy |
Platinum-Resistant Fallopian Tube Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05672095 | — | P1/P2 | withdrawn | Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer |
MMR-D/MSI-H Colorectal Cancers (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06365970 | — | P2 | withdrawn | Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers |
Glioma, Malignant (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06258018 | ONC-2022-001 | P1/P2 | not yet recruiting | Niraparib and Temozolomide in Patients Glioblastoma |
Biliary Tract Neoplasms (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05615818 | SAFIR-ABC10 | P3 | recruiting | Personalized Medicine for Advanced Biliary Cancer Patients |
Castration-Resistant Prostate Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05689021 | — | P2 | active not recruiting | CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations |
Efficacy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06237205 | — | P2 | not yet recruiting | Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency |
SCLC,Extensive Stage (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05718323 | RAISE | P2 | recruiting | Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC |
Locally Advanced Leiomyosarcoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05174455 | — | P2 | withdrawn | Niraparib for the Treatment of Leiomyosarcoma |
Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06141265 | BRAND | P2 | recruiting | Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab |
Recurrent Endometrial Serous Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05870761 | — | P2 | active not recruiting | Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma |
Metastatic Colorectal Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05412706 | Bohème | P2 | withdrawn | Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy |
Brain Metastases (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05700721 | STARLET | P2 | recruiting | Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) |
Metastatic Solid Tumor (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05694715 | — | P1 | recruiting | Combination Therapy in Cancers With Mutations in DNA Repair Genes |
Low-grade Glioma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05406700 | — | Early P1 | active not recruiting | Niraparib In Recurrent IDH 1/2 Gliomas |
Recurrent Endometrial Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05523440 | — | P2 | terminated | Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation |
Advanced Breast Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05238831 | ACT | Early P1 | withdrawn | SMMART Adaptive Clinical Treatment (ACT) Trial |
Penile Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05526989 | — | P2 | recruiting | Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma |
Metastatic Pancreatic Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05442749 | PARPi-PANC | P2 | terminated | Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer |
Homologous Recombination Deficiency (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05461690 | — | P2 | unknown | Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency |
Sarcoma,Soft Tissue (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05515575 | — | P2 | active not recruiting | A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA |
Rectal Neoplasms (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04926324 | — | P1/P2 | terminated | A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers |
Recurrent Small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05162196 | — | P2 | unknown | The Efficacy and Safety of Radiotherapy Plus Niraparib and Toripalimab in Patients With Recurrent Small Cell Lung Cancer |
Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05232006 | PALB2-PARPi-01 | P2 | not yet recruiting | PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers |
Metastatic Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04992013 | — | P2 | active not recruiting | Niraparib in Tumors Metastatic to the CNS |
HER2-negative Metastatic Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05261269 | — | P1 | completed | A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer |
Platinum-resistant Recurrent Clear Cell Ovarian Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05130515 | CC-ANNIE | P2 | completed | Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma. |
Anatomic Stage III Breast Cancer AJCC v8 (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04673448 | — | P1 | active not recruiting | Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer |
HRD (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04895046 | — | P2 | withdrawn | Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma |
Advanced Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04991480 | — | P1 | completed | A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors |
Prostate Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04947254 | — | P2 | recruiting | Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer |
Nasopharyngeal Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05162872 | — | P2 | unknown | Niraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal Carcinoma |
Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04734665 | NIRVANA-R | P2 | unknown | Niraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor |
Recurrent/ Advanced Stage Endometrial Cancer Patients (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04885413 | — | P2 | unknown | An Open-label, Single Arm, Phase II Trial of Niraparib in Combination With Anti-PD1(Programmed Cell Death Protein 1) Antibody in Recurrent/ Advanced Stage Endometrial Cancer Patients |
Anatomic Stage I Breast Cancer AJCC v8 (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04481113 | — | P1 | completed | Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer |
Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04861181 | NIRAPK | P4 | terminated | NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients. |
Urothelial Bladder Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04779151 | NIRADO | P2 | terminated | Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab |
HER2-negative Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04764084 | HRR | P1 | unknown | Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors |
Lung Small Cell Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04701307 | — | P2 | active not recruiting | Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas |
Aggressive Variant Prostate Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04592237 | — | P2 | active not recruiting | Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer |
Metastatic Pancreatic Ductal Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04493060 | — | P2 | completed | Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer |
Stage I Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04584255 | — | P2 | active not recruiting | Niraparib + Dostarlimab In BRCA Mutated Breast Cancer |
Head and Neck Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04313504 | TSR-042 | P2 | completed | Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC |
Lung Cancer, Non-Small Cell (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04475939 | ZEAL-1L | P3 | completed | Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer |
Metastatic Castration-sensitive Prostate Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04497844 | AMPLITUDE | P3 | active not recruiting | A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) |
Treatment Efficacy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04508803 | CHANGEABLE | P2 | completed | Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer |
Rare Tumor (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04423185 | — | P2 | recruiting | PLATFORM Study of Precision Medicine for Rare Tumors |
Ovarian Carcinosarcoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03651206 | ROCSAN | P2/P3 | recruiting | Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib |
Platinum-resistant Ovarian Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04376073 | ANNIE | P2 | unknown | Anlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer |
Cervical Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04395612 | CQGOG0101 | P2 | unknown | Niraparib Combined With Brivanib or Toripalimab in Patients With Cervical Cancer |
Recurrent Cervix Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04068753 | STAR | P2 | active not recruiting | Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer |
Advanced Solid Tumors (Excluding Prostate Cancer) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04267939 | BAY1895344 | P1 | terminated | ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer |
ATM Gene Mutation (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04030559 | — | P2 | terminated | Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects |
Gastric Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04178460 | — | P1 | terminated | A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment |
Metastatic or Locally Advanced Unresectable Solid Tumors (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04170153 | M1774 | P1 | active not recruiting | Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301) |
Advanced Microsatellite Stable Colorectal Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03983993 | NIPAVect | P2 | active not recruiting | Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer |
Urothelial Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03425201 | NICARAGUA | P1/P2 | completed | Niraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA) |
Metastatic Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03368729 | — | P1/P2 | active not recruiting | Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer |
Triple Negative Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03945721 | UNITY | P1 | active not recruiting | A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients |
Esophageal Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03840967 | — | P2 | terminated | A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma |
Deleterious BRCA1 Gene Mutation (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03586661 | — | P1 | active not recruiting | Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
Metastatic Melanoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03925350 | HR | P2 | unknown | Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation |
Advanced Malignant Solid Neoplasm (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03830918 | — | P1/P2 | active not recruiting | Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy |
Metastatic Castration-resistant Prostate Cancer (mCRPC) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03903835 | ProBio | P3 | recruiting | ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer |
Castration-Resistant Prostatic Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03748641 | MAGNITUDE | P3 | active not recruiting | A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer |
OVARIAN CANCER (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03695380 | — | P1 | completed | A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer |
Recurrent Ovarian Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03598270 | ANITA | P3 | completed | Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer |
Ovarian Neoplasm (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05751629 | COHORT-A | P2 | completed | Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer |
Mesothelioma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03207347 | DDR | P2 | completed | A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) |
Advanced Solid Tumors (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03497429 | — | P1 | completed | A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors |
Prostatic Neoplasms, Castration-Resistant (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03431350 | QUEST | P2 | active not recruiting | A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer |
Pancreatic Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03404960 | Parpvax | P1/P2 | completed | Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy |
Carcinoma, Squamous Cell of Head and Neck (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03088059 | UPSTREAM | P2 | unknown | Biomarker-based Study in R/M SCCHN |
Solid Tumor, Adult (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03209401 | — | P1 | terminated | Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies |
Prostate Carcinoma Metastatic to the Bone (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03076203 | — | P1 | completed | Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad) |
Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03221400 | — | P1/P2 | unknown | PEN-866 in Patients With Advanced Solid Malignancies |
Ewing Sarcoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02044120 | — | P1 | completed | ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma |
Breast Neoplasms (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01042379 | I-SPY | P2 | recruiting | I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer |
Metastatic Castration-resistant Prostate Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05401214 | — | N/A | approved for marketing | Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination) |
Niraparib pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| POLO | NCT05187208 | P4 | unknown | Epithelial Ovarian Cancer | 102 | — |
| NIRAPK | NCT04861181 | P4 | terminated | Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer | 12 | — |
| NiQoLe | NCT03752216 | P4 | completed | Ovarian Cancer | 141 | PMID 39673810 |
| OVATION-3 | NCT06915025 | P3 | recruiting | Epithelial Ovarian Cancer | 500 | — |
| FIRST | NCT03602859 | P3 | active not recruiting | Ovarian Neoplasms | 1,400 | — |
| IMbrella B | NCT03768063 | P3 | active not recruiting | Cancer | 1,000 | — |
| SAFIR-ABC10 | NCT05615818 | P3 | recruiting | Biliary Tract Neoplasms | 800 | — |
| AMPLITUDE | NCT04497844 | P3 | active not recruiting | Metastatic Castration-sensitive Prostate Cancer | 696 | PMID 41057655 |
| MAGNITUDE | NCT03748641 | P3 | active not recruiting | Castration-Resistant Prostatic Cancer | 765 | PMID 42015879 |
| ProBio | NCT03903835 | P3 | recruiting | Metastatic Castration-resistant Prostate Cancer (mCRPC) | 750 | PMID 39164518 |
| RUBY | NCT03981796 | P3 | active not recruiting | Neoplasms | 785 | PMID 37731489 |
| GSK3985771 | NCT02655016 | P3 | active not recruiting | Ovarian Neoplasms | 733 | PMID 39013265 |
| ZEAL-1L | NCT04475939 | P3 | completed | Lung Cancer, Non-Small Cell | 666 | PMID 34478166 |
| ZEST | NCT04915755 | P3 | active not recruiting | Neoplasms, Breast | 40 | — |
| NItCHE-MITO33 | NCT04679064 | P3 | unknown | Ovarian Cancer | 427 | PMID 34607820 |
| ANITA | NCT03598270 | P3 | completed | Recurrent Ovarian Carcinoma | 417 | PMID 33318079 |
| BRAVO | NCT01905592 | P3 | terminated | Neoplasms, Breast | 216 | — |
| NIRVANA-1 | NCT05183984 | P2 | recruiting | Ovarian Cancer | 390 | PMID 37650734 |
| I-SPY | NCT01042379 | P2 | recruiting | Breast Neoplasms | 5,000 | PMID 21796368 |
| PALB2-PARPi-01 | NCT05232006 | P2 | not yet recruiting | Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers | 12 | — |
| ProTarget | NCT04341181 | P2 | recruiting | Cancer | 300 | PMID 36814246 |
| KNIGHTS | NCT06212583 | P2 | active not recruiting | Prostate Cancer | 88 | — |
| STARLET | NCT05700721 | P2 | recruiting | Brain Metastases | 120 | — |
| NADiR | NCT04837209 | P2 | active not recruiting | Breast Cancer | 32 | — |
| HARMONY | NCT06392841 | P2 | withdrawn | Metastatic Hormone-sensitive Prostate Cancer (mHSPC) | 0 | — |
| ParpVax2 | NCT06747845 | P2 | recruiting | Pancreatic Adenocarcinoma Metastatic | 68 | — |
| PRIME | NCT04681469 | P2 | recruiting | Head and Neck Squamous Cell Carcinoma | 49 | — |
| REPRESENTATION | NCT06527690 | P2 | withdrawn | Prostate Cancer | 0 | — |
| ANALLISA | NCT06180356 | P2 | recruiting | Ovarian Cancer | 30 | — |
| DRUP | NCT02925234 | P2 | recruiting | Cancer | 1,550 | PMID 37424386 |
| BRAND | NCT06141265 | P2 | recruiting | Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma | 116 | — |
| STAR | NCT04068753 | P2 | active not recruiting | Recurrent Cervix Cancer | 66 | — |
| SOPRANO | NCT05990192 | P2 | recruiting | Ovarian Cancer Recurrent | 42 | — |
| RAISE | NCT05718323 | P2 | recruiting | SCLC,Extensive Stage | 44 | — |
| QUEST | NCT03431350 | P2 | active not recruiting | Prostatic Neoplasms, Castration-Resistant | 136 | — |
| NIPAVect | NCT03983993 | P2 | active not recruiting | Advanced Microsatellite Stable Colorectal Carcinoma | 26 | — |
| GUNS | NCT04812366 | P2 | recruiting | Prostate Cancer | 315 | — |
| TSR-042 | NCT04313504 | P2 | completed | Head and Neck Cancer | 10 | — |
| UPSTREAM | NCT03088059 | P2 | unknown | Carcinoma, Squamous Cell of Head and Neck | 340 | PMID 30307465 |
| UNITO-001 | NCT04940637 | P2 | unknown | Lung Cancer | 70 | — |
| COHORT-C | NCT06964165 | P2 | terminated | Ovarian Neoplasms | 36 | — |
| OPAL | NCT03574779 | P2 | completed | Ovarian Neoplasms | 77 | PMID 38754056 |
| NIRADO | NCT04779151 | P2 | terminated | Urothelial Bladder Cancer | 51 | — |
| NIRA-PANC | NCT03553004 | P2 | unknown | Pancreatic Cancer | 18 | PMID 37759489 |
| NERO | NCT05455424 | P2 | completed | Mesothelioma, Malignant | 88 | PMID 37993149 |
| MEGALiT | NCT04185831 | P2 | active not recruiting | Solid Tumor | 167 | — |
| t | NCT05385068 | P2 | unknown | Epithelial Ovarian Cancer | 35 | — |
| Newton | NCT03891576 | P2 | terminated | Ovarian Cancer | 83 | PMID 41950571 |
| PARPi-PANC | NCT05442749 | P2 | terminated | Metastatic Pancreatic Cancer | 2 | — |
| PAVO | NCT05169437 | P2 | terminated | Solid Tumor | 22 | — |
| NIRVANA-R | NCT04734665 | P2 | unknown | Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor | 44 | PMID 34910393 |
| OU-SCC-PI-4G | NCT05297864 | P2 | terminated | Recurrent Glioblastoma | 15 | — |
| LUZERN | NCT04240106 | P2 | completed | Breast Cancer | 14 | — |
| MiST | NCT03654833 | P2 | unknown | Mesothelioma, Malignant | 186 | PMID 35157829 |
| NEOPRIMA | NCT04284852 | P2 | completed | Ovarian Cancer | 20 | — |
| Bohème | NCT05412706 | P2 | withdrawn | Metastatic Colorectal Cancer | 0 | — |
| EUDARIO | NCT03783949 | P2 | completed | Ovarian Cancer | 122 | — |
| Galahad | NCT02854436 | P2 | completed | Prostatic Neoplasms | 289 | PMID 35131040 |
| CHANGEABLE | NCT04508803 | P2 | completed | Treatment Efficacy | 37 | — |
| HR | NCT03925350 | P2 | unknown | Metastatic Melanoma | 41 | PMID 40373259 |
| CC-ANNIE | NCT05130515 | P2 | completed | Platinum-resistant Recurrent Clear Cell Ovarian Cancer | 6 | — |
| AVANIRA3 | NCT04556071 | P2 | unknown | Ovarian Neoplasms | 32 | — |
| DDR | NCT03207347 | P2 | completed | Mesothelioma | 37 | PMID 39626160 |
| CQGOG0101 | NCT04395612 | P2 | unknown | Cervical Cancer | 38 | PMID 25651787 |
| COHORT-A | NCT05751629 | P2 | completed | Ovarian Neoplasm | 41 | — |
| ANNIE | NCT04376073 | P2 | unknown | Platinum-resistant Ovarian Cancer | 40 | PMID 36583171 |
| MOONSTONE | NCT03955471 | P2 | terminated | Ovarian Neoplasms | 41 | PMID 37890345 |
| PD-1 | NCT03308942 | P2 | completed | Neoplasms | 53 | — |
| QUADRA | NCT02354586 | P2 | completed | Ovarian Neoplasms | 463 | PMID 30948273 |
Terminated and withdrawn Niraparib trials (38)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT06161493withdrawnZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors
- NCT06392841withdrawnNiraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
- NCT06329830withdrawn177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer
- NCT06527690withdrawnRace Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer
- NCT06365970withdrawnNiraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers
- NCT04149145withdrawnTrial of M4344 and Niraparib in Patients With Poly (ADP-ribose) Polymerase (PARP) Resistant Recurrent Ovarian Cancer
- NCT05672095withdrawnNiraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer
- NCT05126342withdrawnStudy to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi
- NCT05238831withdrawnSMMART Adaptive Clinical Treatment (ACT) Trial
- NCT05289648withdrawnNiraparib in High-grade Endometrial Cancer Trial
- NCT04762901withdrawnLCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer
- NCT05174455withdrawnNiraparib for the Treatment of Leiomyosarcoma
- NCT04030559terminatedNiraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects
- NCT04159155terminatedA Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer
- NCT04544995terminatedDose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)
- NCT04861181terminatedNIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients.
- NCT06964165terminatedA Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)
- NCT04779151terminatedBasket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab
- NCT05523440terminatedBevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation
- NCT03806049withdrawnTrial Comparing Niraparib-bevacizumab-Dostarlimab and Niraparib-bevacizumab to Standard of Care in Recurrent Ovarian Cancer
- NCT04926324terminatedA Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers
- NCT03891576terminatedNewton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)
- NCT05442749terminatedNiraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer
- NCT05169437terminatedNiraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
- NCT04826198terminatedSafety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With PARP Inhibitors Since at Least 6 Months
- NCT05297864terminatedPARP Inhibition for Gliomas (PI-4G or π4g)
- NCT04267939terminatedATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer
- NCT03209401terminatedNiraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies
- NCT05666349withdrawnReirradiation and Niraparib in Patients With Recurrent Glioblastoma
- NCT04895046withdrawnMaintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma
- NCT05412706withdrawnNiraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
- NCT04655183withdrawnStudy of M4344 in Combination With Niraparib
- NCT03840967terminatedA Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma
- NCT02826512terminatedA Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients
- NCT04178460terminatedA Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment
- NCT03955471terminatedStudy to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer
- NCT01905592terminatedA Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
- NCT02500901terminatedEnzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)
All Niraparib trials (199)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06915025 | OVATION-3 | Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer | P3 | recruiting | 500 | Imunon | Jul 2025 |
| NCT05183984 | NIRVANA-1 | Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer | P2 | recruiting | 390 | ARCAGY/ GINECO GROUP | Feb 2022 |
| NCT05009082 | Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer | P3 | recruiting | 970 | AGO Study Group | Sep 2022 | |
| NCT01042379 | I-SPY | I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | P2 | recruiting | 5,000 | QuantumLeap Healthcare Collaborative | Mar 2010 |
| NCT06412120 | Study Evaluating Safety, Tolerability, and Metabolism of Niraparib | P4 | recruiting | 70 | University of Miami | Aug 2026 | |
| NCT05232006 | PALB2-PARPi-01 | PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers | P2 | not yet recruiting | 12 | Assistance Publique - Hôpitaux de Paris | May 2022 |
| NCT04341181 | ProTarget | ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling | P2 | recruiting | 300 | Ulrik Lassen | Aug 2020 |
| NCT06212583 | KNIGHTS | High-Risk Metachronous Oligometastatic Prostate Cancer Trial | P2 | active not recruiting | 88 | University of Maryland, Baltimore | Apr 2024 |
| NCT06161493 | ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors | P1 | withdrawn | 0 | Haider Mahdi | Jan 2024 | |
| NCT05700721 | STARLET | Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) | P2 | recruiting | 120 | M.D. Anderson Cancer Center | Jun 2023 |
| NCT06953323 | A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors | P1/P2 | recruiting | 86 | Wigen Biomedicine Technology (Shanghai) Co., Ltd. | Jul 2025 | |
| NCT06682780 | A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours | P1/P2 | recruiting | 320 | LaNova Medicines Limited | Sep 2025 | |
| NCT04837209 | NADiR | Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer | P2 | active not recruiting | 32 | Massachusetts General Hospital | Jul 2021 |
| NCT04584255 | Niraparib + Dostarlimab In BRCA Mutated Breast Cancer | P2 | active not recruiting | 62 | Dana-Farber Cancer Institute | Dec 2020 | |
| NCT04194554 | ASCLEPIuS | A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer | P1/P2 | active not recruiting | 102 | University of Michigan Rogel Cancer Center | Nov 2020 |
| NCT03602859 | FIRST | A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer | P3 | active not recruiting | 1,400 | Tesaro, Inc. | Oct 2018 |
| NCT05784012 | RADIAN | Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma | P1/P2 | active not recruiting | 34 | Grupo Español de Tratamiento de Tumores de Cabeza y Cuello | Nov 2023 |
| NCT03651206 | ROCSAN | Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib | P2/P3 | recruiting | 138 | ARCAGY/ GINECO GROUP | Jul 2020 |
| NCT06392841 | HARMONY | Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations | P2 | withdrawn | 0 | Qian Qin | Oct 2025 |
| NCT06747845 | ParpVax2 | Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy | P2 | recruiting | 68 | Abramson Cancer Center at Penn Medicine | May 2025 |
| NCT03945721 | UNITY | A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients | P1 | active not recruiting | 21 | Massachusetts General Hospital | Jul 2019 |
| NCT06329830 | LUNAAR | 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer | P1/P2 | withdrawn | 0 | Baptist Health South Florida | Oct 2024 |
| NCT03768063 | IMbrella B | A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study | P3 | active not recruiting | 1,000 | Hoffmann-La Roche | Feb 2019 |
| NCT04423185 | PLATFORM Study of Precision Medicine for Rare Tumors | P2 | recruiting | 770 | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Aug 2020 | |
| NCT05615818 | SAFIR-ABC10 | Personalized Medicine for Advanced Biliary Cancer Patients | P3 | recruiting | 800 | UNICANCER | Jul 2024 |
| NCT05601440 | Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer | P2 | recruiting | 484 | Canadian Cancer Trials Group | Jun 2023 | |
| NCT04681469 | PRIME | Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC | P2 | recruiting | 49 | Gruppo Oncologico del Nord-Ovest | Feb 2021 |
| NCT07059676 | LIBINI-1 | Design and Validation of Plasma Proteins and Cytokine Panels to Identify Markers Associated With Response to Niraparib as Maintenance Treatment After First-line Platinum-based Regimen in Patients With Advanced Ovarian Cancer | — | not yet recruiting | 120 | Clinica Universidad de Navarra, Universidad de Navarra | Jul 2025 |
| NCT06388733 | A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma | P3 | recruiting | 450 | Ivy Brain Tumor Center | Jun 2024 | |
| NCT06527690 | REPRESENTATION | Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer | P2 | withdrawn | 0 | Latin American Cooperative Oncology Group | Apr 2025 |
| NCT06365970 | Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers | P2 | withdrawn | 0 | Ibrahim Halil Sahin | Jan 2025 | |
| NCT06180356 | ANALLISA | Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression | P2 | recruiting | 30 | MedSIR | Dec 2024 |
| NCT05694715 | Combination Therapy in Cancers With Mutations in DNA Repair Genes | P1 | recruiting | 24 | University of California, San Francisco | May 2023 | |
| NCT05519670 | CAPRICE | A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr | P1/P2 | not yet recruiting | 72 | Institut Paoli-Calmettes | Mar 2023 |
| NCT04592237 | Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer | P2 | active not recruiting | 120 | M.D. Anderson Cancer Center | Dec 2020 | |
| NCT02925234 | DRUP | The Drug Rediscovery Protocol (DRUP Trial) | P2 | recruiting | 1,550 | The Netherlands Cancer Institute | Aug 2016 |
| NCT05335993 | A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer. | P2 | active not recruiting | 10 | CanariaBio Inc. | Jul 2022 | |
| NCT03368729 | Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer | P1/P2 | active not recruiting | 46 | University of Alabama at Birmingham | Sep 2019 | |
| NCT05526989 | Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma | P2 | recruiting | 25 | H. Lee Moffitt Cancer Center and Research Institute | Dec 2022 | |
| NCT04497844 | AMPLITUDE | A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) | P3 | active not recruiting | 696 | Janssen Research & Development, LLC | Sep 2020 |
| NCT04502602 | iNNOVATE | Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer | P1 | active not recruiting | 18 | Virginia Commonwealth University | Aug 2020 |
| NCT06258018 | ONC-2022-001 | Niraparib and Temozolomide in Patients Glioblastoma | P1/P2 | not yet recruiting | 86 | Armando Santoro, MD | Sep 2024 |
| NCT06141265 | BRAND | Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab | P2 | recruiting | 116 | Peking University Cancer Hospital & Institute | Nov 2023 |
| NCT05961124 | Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer | P2 | recruiting | 40 | Sunnybrook Health Sciences Centre | Aug 2023 | |
| NCT06594679 | NICHOL | A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL) | P1/P2 | recruiting | 73 | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Sep 2024 |
| NCT04068753 | STAR | Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer | P2 | active not recruiting | 66 | University of Oklahoma | Feb 2020 |
| NCT05990192 | SOPRANO | SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy | P2 | recruiting | 42 | Institute of Cancer Research, United Kingdom | Jun 2024 |
| NCT06237205 | Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency | P2 | not yet recruiting | 33 | Korea University Anam Hospital | Feb 2024 | |
| NCT05718323 | RAISE | Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC | P2 | recruiting | 44 | ETOP IBCSG Partners Foundation | Dec 2023 |
| NCT04992013 | Niraparib in Tumors Metastatic to the CNS | P2 | active not recruiting | 20 | Massachusetts General Hospital | Apr 2022 | |
| NCT04149145 | PARP | Trial of M4344 and Niraparib in Patients With Poly (ADP-ribose) Polymerase (PARP) Resistant Recurrent Ovarian Cancer | P1 | withdrawn | 0 | University of Alabama at Birmingham | May 2023 |
| NCT04701307 | Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas | P2 | active not recruiting | 48 | M.D. Anderson Cancer Center | Feb 2021 | |
| NCT05076513 | Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma | Early P1 | active not recruiting | 42 | Nader Sanai | Oct 2021 | |
| NCT03748641 | MAGNITUDE | A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer | P3 | active not recruiting | 765 | Janssen Research & Development, LLC | Jan 2019 |
| NCT03830918 | Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy | P1/P2 | active not recruiting | 59 | Jonsson Comprehensive Cancer Center | Mar 2019 | |
| NCT04716686 | Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma | P2 | recruiting | 83 | Shandong University | Jun 2021 | |
| NCT04507841 | Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer | P2 | active not recruiting | 67 | Tongji Hospital | Jan 2021 | |
| NCT04577833 | AA | A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer | P1 | active not recruiting | 136 | Janssen Research & Development, LLC | Nov 2020 |
| NCT03983226 | Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial) | P2 | recruiting | 167 | Shanghai Gynecologic Oncology Group | Oct 2019 | |
| NCT03586661 | Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | P1 | active not recruiting | 31 | M.D. Anderson Cancer Center | Apr 2019 | |
| NCT03903835 | ProBio | ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer | P3 | recruiting | 750 | Karolinska Institutet | Feb 2019 |
| NCT03431350 | QUEST | A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer | P2 | active not recruiting | 136 | Janssen Research & Development, LLC | Mar 2018 |
| NCT03983993 | NIPAVect | Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer | P2 | active not recruiting | 26 | Emory University | Oct 2019 |
| NCT05672095 | Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer | P1/P2 | withdrawn | 0 | City of Hope Medical Center | Apr 2025 | |
| NCT03981796 | RUBY | A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer | P3 | active not recruiting | 785 | Tesaro, Inc. | Jul 2019 |
| NCT04641247 | A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study | P2 | recruiting | 30 | GlaxoSmithKline | Apr 2021 | |
| NCT05126342 | Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi | P2 | withdrawn | 0 | AGO Research GmbH | Nov 2023 | |
| NCT05406700 | Niraparib In Recurrent IDH 1/2 Gliomas | Early P1 | active not recruiting | 16 | Massachusetts General Hospital | May 2023 | |
| NCT04673448 | Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer | P1 | active not recruiting | 18 | University of Washington | Oct 2021 | |
| NCT05515575 | A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA | P2 | active not recruiting | 8 | Memorial Sloan Kettering Cancer Center | Aug 2022 | |
| NCT05689021 | CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations | P2 | active not recruiting | 8 | Mayo Clinic | Mar 2024 | |
| NCT05870761 | Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma | P2 | active not recruiting | 8 | Casey Cosgrove | Oct 2023 | |
| NCT04170153 | M1774 | Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301) | P1 | active not recruiting | 161 | EMD Serono Research & Development Institute, Inc. | Dec 2019 |
| NCT06887933 | A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer | P4 | not yet recruiting | 67 | GlaxoSmithKline | Apr 2025 | |
| NCT06077877 | PK | A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors | P1/P2 | active not recruiting | 42 | GlaxoSmithKline | Oct 2023 |
| NCT06433219 | Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302) | P2 | active not recruiting | 63 | EMD Serono Research & Development Institute, Inc. | Oct 2024 | |
| NCT04947254 | Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer | P2 | recruiting | 200 | M.D. Anderson Cancer Center | Aug 2021 | |
| NCT05238831 | ACT | SMMART Adaptive Clinical Treatment (ACT) Trial | Early P1 | withdrawn | 0 | OHSU Knight Cancer Institute | Jan 2023 |
| NCT02655016 | GSK3985771 | A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy | P3 | active not recruiting | 733 | Tesaro, Inc. | Jul 2016 |
| NCT04812366 | GUNS | Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer | P2 | recruiting | 315 | University of British Columbia | Sep 2021 |
| NCT05021562 | A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice | — | completed | 354 | Takeda | Sep 2021 | |
| NCT04475939 | ZEAL-1L | Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer | P3 | completed | 666 | GlaxoSmithKline | Oct 2020 |
| NCT04313504 | TSR-042 | Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC | P2 | completed | 10 | Trisha Wise-Draper | Nov 2020 |
| NCT03601923 | Niraparib in Patients With Pancreatic Cancer | P2 | completed | 32 | Dana-Farber Cancer Institute | Aug 2018 | |
| NCT05289648 | NIREC | Niraparib in High-grade Endometrial Cancer Trial | Early P1 | withdrawn | 0 | Sir Mortimer B. Davis - Jewish General Hospital | May 2024 |
| NCT04762901 | LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer | P1 | withdrawn | 0 | Wake Forest University Health Sciences | Apr 2021 | |
| NCT04221503 | Niraparib/TTFields in GBM | P2 | active not recruiting | 30 | Abramson Cancer Center at Penn Medicine | Dec 2019 | |
| NCT05198804 | A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer | P1/P2 | completed | 117 | K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc | Jan 2022 | |
| NCT06614790 | NIRAPARIB | Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study. | — | recruiting | 300 | Pomeranian Medical University Szczecin | Sep 2024 |
| NCT05174455 | Niraparib for the Treatment of Leiomyosarcoma | P2 | withdrawn | 0 | David Liebner, MD | Dec 2023 | |
| NCT05187208 | POLO | PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer | P4 | unknown | 102 | Seoul National University Hospital | Jan 2022 |
| NCT04915755 | ZEST | Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease | P3 | active not recruiting | 40 | GlaxoSmithKline | Jun 2021 |
| NCT03088059 | UPSTREAM | Biomarker-based Study in R/M SCCHN | P2 | unknown | 340 | European Organisation for Research and Treatment of Cancer - EORTC | Nov 2017 |
| NCT03016338 | Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer | P2 | unknown | 51 | University Health Network, Toronto | Nov 2017 | |
| NCT04991480 | A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors | P1 | completed | 93 | Artios Pharma Ltd | Sep 2021 | |
| NCT04037254 | Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring | P1/P2 | completed | 22 | NRG Oncology | Oct 2019 | |
| NCT03869190 | MORPHEUS-UC | Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) | P1/P2 | completed | 272 | Hoffmann-La Roche | Jun 2019 |
| NCT04030559 | Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects | P2 | terminated | 11 | University of California, Davis | Feb 2020 | |
| NCT06827353 | OVNI-B | Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency | — | recruiting | 300 | Centre Hospitalier Universitaire de Nīmes | Oct 2020 |
| NCT05461690 | Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency | P2 | unknown | 50 | Zhejiang Cancer Hospital | Sep 2022 | |
| NCT04940637 | UNITO-001 | UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC | P2 | unknown | 70 | University of Turin, Italy | Dec 2020 |
| NCT04481113 | Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer | P1 | completed | 8 | OHSU Knight Cancer Institute | Jun 2021 | |
| NCT05065021 | Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor | P2 | unknown | 40 | University Health Network, Toronto | Feb 2023 | |
| NCT04493060 | Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer | P2 | completed | 22 | Mayo Clinic | Dec 2020 | |
| NCT05641506 | A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer | P2 | unknown | 50 | Sichuan Cancer Hospital and Research Institute | Dec 2022 | |
| NCT04159155 | CAN-STAMP | A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer | P2/P3 | terminated | 11 | University Health Network, Toronto | Nov 2020 |
| NCT04544995 | SCOOP | Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP) | P1 | terminated | 47 | GlaxoSmithKline | Oct 2020 |
| NCT04861181 | NIRAPK | NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients. | P4 | terminated | 12 | Hospices Civils de Lyon | May 2021 |
| NCT06964165 | COHORT-C | A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C) | P2 | terminated | 36 | Tesaro, Inc. | Apr 2022 |
| NCT03574779 | OPAL | A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer | P2 | completed | 77 | Tesaro, Inc. | Nov 2018 |
| NCT04986371 | RENI-1 | Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer | — | unknown | 300 | Ling-Ying Wu | Aug 2021 |
| NCT04779151 | NIRADO | Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab | P2 | terminated | 51 | Gustave Roussy, Cancer Campus, Grand Paris | Apr 2021 |
| NCT03553004 | NIRA-PANC | Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial | P2 | unknown | 18 | University of Kansas Medical Center | Jan 2019 |
| NCT05455424 | NERO | Niraparib Efficacy in Patient With Unresectable Mesothelioma | P2 | completed | 88 | University Hospital Southampton NHS Foundation Trust | Jul 2022 |
| NCT05523440 | Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation | P2 | terminated | 9 | University of Oklahoma | Feb 2023 | |
| NCT04679064 | NItCHE-MITO33 | Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment | P3 | unknown | 427 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Dec 2020 |
| NCT04080284 | Trial of Maintenance With Niraparib- Uterine Serous Carcinoma | P2 | completed | 22 | Northwell Health | Dec 2019 | |
| NCT05162196 | The Efficacy and Safety of Radiotherapy Plus Niraparib and Toripalimab in Patients With Recurrent Small Cell Lung Cancer | P2 | unknown | 57 | Wuhan University | Jun 2022 | |
| NCT03806049 | Trial Comparing Niraparib-bevacizumab-Dostarlimab and Niraparib-bevacizumab to Standard of Care in Recurrent Ovarian Cancer | P3 | withdrawn | 0 | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Dec 2019 | |
| NCT04926324 | A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers | P1/P2 | terminated | 3 | University of Iowa | Jul 2022 | |
| NCT03307785 | Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 | P1 | completed | 60 | Tesaro, Inc. | Oct 2017 | |
| NCT04185831 | MEGALiT | A MolEcularly Guided Anti-Cancer Drug Off-Label Trial | P2 | active not recruiting | 167 | Uppsala University Hospital | Oct 2020 |
| NCT03404960 | Parpvax | Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy | P1/P2 | completed | 104 | University of Pennsylvania | Jan 2018 |
| NCT05385068 | t | A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi | P2 | unknown | 35 | Peking Union Medical College Hospital | Jun 2022 |
| NCT03891576 | Newton | Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer) | P2 | terminated | 83 | Mario Negri Institute for Pharmacological Research | Nov 2019 |
| NCT05442749 | PARPi-PANC | Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer | P2 | terminated | 2 | Centre Leon Berard | Oct 2022 |
| NCT05169437 | PAVO | Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors | P2 | terminated | 22 | Tempus AI | Mar 2022 |
| NCT03598270 | ANITA | Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer | P3 | completed | 417 | Grupo Español de Investigación en Cáncer de Ovario | Nov 2018 |
| NCT03425201 | NICARAGUA | Niraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA) | P1/P2 | completed | 67 | Fundacion CRIS de Investigación para Vencer el Cáncer | Oct 2019 |
| NCT03326193 | A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy | P2 | completed | 105 | Tesaro, Inc. | Dec 2017 | |
| NCT03891615 | Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer | P1 | unknown | 30 | Massachusetts General Hospital | Jun 2019 | |
| NCT04826198 | REVOCAN | Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With PARP Inhibitors Since at Least 6 Months | P1/P2 | terminated | 13 | Gustave Roussy, Cancer Campus, Grand Paris | Oct 2020 |
| NCT04734665 | NIRVANA-R | Niraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor | P2 | unknown | 44 | Yonsei University | Jul 2021 |
| NCT05311579 | Niraparib Plus Anlotinib for Recurrent Ovarian Cancer | P2 | unknown | 36 | Lei Li | Mar 2022 | |
| NCT04288687 | A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects | P2 | completed | 11 | Abramson Cancer Center at Penn Medicine | Oct 2020 | |
| NCT05297864 | OU-SCC-PI-4G | PARP Inhibition for Gliomas (PI-4G or π4g) | P2 | terminated | 15 | University of Oklahoma | Jun 2022 |
| NCT04267939 | BAY1895344 | ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer | P1 | terminated | 14 | Bayer | Feb 2020 |
| NCT04240106 | LUZERN | Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN) | P2 | completed | 14 | MedSIR | Jun 2020 |
| NCT03654833 | MiST | Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma | P2 | unknown | 186 | University of Leicester | Jan 2019 |
| NCT05162872 | Niraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal Carcinoma | P2 | unknown | 99 | Sun Yat-sen University | Aug 2021 | |
| NCT03209401 | Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies | P1 | terminated | 23 | Georgetown University | Oct 2017 | |
| NCT05666349 | RiNG | Reirradiation and Niraparib in Patients With Recurrent Glioblastoma | P1 | withdrawn | 0 | University College, London | Oct 2023 |
| NCT05261269 | A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer | P1 | completed | 30 | Dantari, Inc. | Feb 2022 | |
| NCT04284852 | NEOPRIMA | Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting | P2 | completed | 20 | The University of Hong Kong | May 2020 |
| NCT04895046 | Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma | P2 | withdrawn | 0 | Walid Shaib, MD | Oct 2021 | |
| NCT05412706 | Bohème | Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy | P2 | withdrawn | 0 | Ospedale Policlinico San Martino | Sep 2023 |
| NCT04655183 | Study of M4344 in Combination With Niraparib | P1/P2 | withdrawn | 0 | EMD Serono Research & Development Institute, Inc. | Dec 2020 | |
| NCT03783949 | EUDARIO | European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer | P2 | completed | 122 | Universitaire Ziekenhuizen KU Leuven | Nov 2018 |
| NCT02854436 | Galahad | An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies | P2 | completed | 289 | Janssen Research & Development, LLC | Aug 2016 |
| NCT03695380 | A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer | P1 | completed | 77 | Hoffmann-La Roche | Jan 2019 | |
| NCT03221400 | PEN-866 in Patients With Advanced Solid Malignancies | P1/P2 | unknown | 340 | Tarveda Therapeutics | Aug 2017 | |
| NCT03329001 | Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule | P1 | completed | 236 | Tesaro, Inc. | Dec 2017 | |
| NCT04885413 | An Open-label, Single Arm, Phase II Trial of Niraparib in Combination With Anti-PD1(Programmed Cell Death Protein 1) Antibody in Recurrent/ Advanced Stage Endometrial Cancer Patients | P2 | unknown | 37 | Sun Yat-sen University | Jul 2021 | |
| NCT03154281 | Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast | P1 | completed | 14 | Avera McKennan Hospital & University Health Center | Jul 2017 | |
| NCT04235101 | Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors | P1 | completed | 32 | Byondis B.V. | Jun 2020 | |
| NCT04764084 | HRR | Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors | P1 | unknown | 52 | Peking University Cancer Hospital & Institute | Apr 2021 |
| NCT04508803 | CHANGEABLE | Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer | P2 | completed | 37 | Fudan University | Sep 2020 |
| NCT03925350 | HR | Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation | P2 | unknown | 41 | California Pacific Medical Center Research Institute | Mar 2019 |
| NCT03840967 | A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma | P2 | terminated | 14 | Shadia Jalal, MD | Jul 2019 | |
| NCT05734911 | Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study | — | completed | 199 | Zhongda Hospital | Jan 2019 | |
| NCT04715620 | Niraparib Combined With Radiotherapy in rGBM | P2 | unknown | 30 | Tianjin Huanhu Hospital | Jan 2021 | |
| NCT05130515 | CC-ANNIE | Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma. | P2 | completed | 6 | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Dec 2021 |
| NCT03759587 | Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer | P2 | completed | 19 | Takeda | Dec 2018 | |
| NCT03759600 | Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer | P2 | completed | 20 | Takeda | Dec 2018 | |
| NCT03752216 | NiQoLe | NIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib. | P4 | completed | 141 | ARCAGY/ GINECO GROUP | Apr 2019 |
| NCT03076203 | Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad) | P1 | completed | 14 | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Sep 2017 | |
| NCT06086665 | REFIRM | The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer | — | completed | 850 | Asan Medical Center | Dec 2019 |
| NCT04556071 | AVANIRA3 | Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer | P2 | unknown | 32 | Xiaoxiang Chen | Nov 2020 |
| NCT04774406 | Arterial Hypertension Related to PARP Inhibitors (ArteRIB) | — | completed | 2,336 | University Hospital, Caen | Feb 2021 | |
| NCT03207347 | DDR | A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) | P2 | completed | 37 | University of Florida | Aug 2018 |
| NCT04392102 | A Study of Niraparib in Patients With Relapsed Ovarian Cancer | P2 | completed | 15 | Zai Lab (Shanghai) Co., Ltd. | Aug 2020 | |
| NCT04395612 | CQGOG0101 | Niraparib Combined With Brivanib or Toripalimab in Patients With Cervical Cancer | P2 | unknown | 38 | Chongqing University Cancer Hospital | May 2020 |
| NCT02826512 | A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients | P2 | terminated | 9 | The Netherlands Cancer Institute | May 2018 | |
| NCT05401214 | Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination) | — | approved for marketing | 0 | Janssen Research & Development, LLC | — | |
| NCT04217798 | Efficacy and Safety of Niraparib Combined With Oral Etoposide in Platinum Resistant/Refractory Recurrent Ovarian Cancer | P2 | unknown | 36 | Peking Union Medical College Hospital | May 2020 | |
| NCT05751629 | COHORT-A | Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer | P2 | completed | 41 | Tesaro, Inc. | Nov 2018 |
| NCT04376073 | ANNIE | Anlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer | P2 | unknown | 40 | Jihong Liu | May 2020 |
| NCT04178460 | A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment | P1 | terminated | 60 | Zai Lab (Shanghai) Co., Ltd. | Feb 2020 | |
| NCT04409002 | Niraparib + Dostarlimab + RT in Pancreatic Cancer | P2 | completed | 18 | Massachusetts General Hospital | Jul 2020 | |
| NCT03955471 | MOONSTONE | Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer | P2 | terminated | 41 | Tesaro, Inc. | Oct 2019 |
| NCT01847274 | A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer | P3 | completed | 596 | Tesaro, Inc. | Jun 2013 | |
| NCT02354131 | AVANOVA | Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer | P1/P2 | completed | 108 | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Feb 2015 |
| NCT01905592 | BRAVO | A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients | P3 | terminated | 216 | Tesaro, Inc. | Feb 2014 |
| NCT02657889 | TOPACIO | Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer | P1/P2 | completed | 122 | Tesaro, Inc. | Apr 2016 |
| NCT03945084 | Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy | P2 | completed | 58 | University of Turin, Italy | Aug 2019 | |
| NCT03308942 | PD-1 | Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants | P2 | completed | 53 | Tesaro, Inc. | Sep 2017 |
| NCT02354586 | QUADRA | A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens | P2 | completed | 463 | Tesaro, Inc. | Mar 2015 |
| NCT04546373 | Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer | — | completed | 316 | Grupo Español de Investigación en Cáncer de Ovario | Sep 2020 | |
| NCT02044120 | ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma | P1 | completed | 34 | Sarcoma Alliance for Research through Collaboration | May 2014 | |
| NCT04785716 | Real-life Use of Niraparib in a Patient Access Program in Norway | — | completed | 106 | Kristina Lindemann | Jul 2017 | |
| NCT03359850 | Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients | P1 | completed | 17 | Tesaro, Inc. | Feb 2018 | |
| NCT03895788 | A Study of Niraparib in Combination With Brivanib in Recurrent Ovarian Cancer | P1 | unknown | 24 | Hunan Cancer Hospital | Jan 2019 | |
| NCT03329937 | Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer | P1 | completed | 21 | Tesaro, Inc. | Apr 2018 | |
| NCT03497429 | A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors | P1 | completed | 9 | Takeda | Apr 2018 | |
| NCT02924766 | BEDIVERE | A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) | P1 | completed | 34 | Janssen Research & Development, LLC | Oct 2016 |
| NCT03551171 | The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer | P1 | completed | 42 | Zai Lab (Shanghai) Co., Ltd. | Dec 2017 | |
| NCT02476552 | Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer | P1 | completed | 12 | Tesaro, Inc. | Feb 2015 | |
| NCT03025867 | Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer | — | approved for marketing | 0 | Tesaro, Inc. | — | |
| NCT02500901 | CRPC | Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) | P1 | terminated | 2 | Paul Mathew, MD | Mar 2016 |
Niraparib clinical trials: frequently asked questions
- How many Niraparib clinical trials are there?
- 199 Niraparib clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 33 are actively recruiting participants. 56 are marked completed.
- Are Niraparib clinical trials recruiting in 2026?
- Yes — 33 Niraparib trials are actively recruiting in 2026, with 94 U.S. sites across 30 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Niraparib being studied for?
- Niraparib is being studied for Ovarian Cancer, Ovarian Neoplasms, Breast Cancer, Fallopian Tube Cancer, Neoplasms and 345 more. The trials are grouped by indication on this page.
- What phase is Niraparib in?
- Niraparib clinical trials span 5 Phase 4, 18 Phase 3, 100 Phase 2, 35 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Niraparib clinical trials?
- The lead sponsor across the most Niraparib trials is Tesaro, Inc., with 130 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Niraparibas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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Related pages on Hipa.ai: