Niraparib Clinical Trials (2026): 199 Studies for Ovarian Cancer & Ovarian Neoplasms

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

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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.

StateFacilityCityTrialMap
ALUniversity of Alabama at BirminghamBirmingham35294NCT01042379Map
ALUniversity of Alabama at BirminghamBirmingham35233NCT06388733Map
AZIvy Brain Tumor CenterPhoenix85013NCT06388733Map
CAUniversity of California - Davis, Comprehensive Cancer CenterDavis95817NCT01042379Map
CACity of HopeDuarte91010NCT01042379Map
CAGSK Investigational SiteEncinitas92024NCT04641247Map
CAMoores UCSD Cancer CenterLa Jolla92093NCT06388733Map
CAScripps Cancer CenterLa Jolla92037NCT06388733Map
CAUniversity of California San DiegoLa Jolla92093-0698NCT01042379Map
CAGSK Investigational SiteLos Angeles90048NCT04641247Map
CAUniversity of Southern CaliforniaLos Angeles90033NCT01042379Map
CAHOAG Memorial Hospital PresbyterianNewport Beach92663NCT01042379Map
CAUniversity of California DavisSacramento95817NCT04812366Map
CAUniversity of California San Francisco (UCSF)San Francisco94115NCT01042379Map
CAUniversity of California, San FranciscoSan Francisco94143NCT05694715Map
COUniversity of Colorado Cancer CenterAurora80045NCT01042379Map
CTSmilow Cancer Hospital at Yale New HavenGuilford06437NCT06388733Map
CTYale Cancer CenterNew Haven06510NCT01042379Map
DCGeorgetown University Medical CenterWashington D.C.20007NCT01042379Map
FLBroward HealthFort Lauderdale33316NCT06412120Map
FLUniversity of Florida JacksonvilleJacksonville32209NCT06412120Map
FLUniversity of MiamiMiami33136NCT06412120Map
FLAdvent HealthOrlando32804NCT06915025Map
FLH. Lee Moffitt Cancer Center and Research InstituteTampa33612NCT01042379Map
FLMoffitt Cancer CenterTampa33612NCT05526989Map
FLMoffitt Cancer CenterTampa33612NCT01042379Map
GAGSK Investigational SiteAtlanta30342NCT04641247Map
GAWinship Cancer Institute of Emory UniversityAtlanta30322NCT01042379Map
ILUniversity of ChicagoChicago60453NCT01042379Map
ILGSK Investigational SiteHarvey60426NCT04641247Map
ILLoyola UniversityMaywood60153NCT01042379Map
INIndiana UniversityIndianapolis46202NCT06388733Map
LAThe NeuroMedical CenterBaton Rouge70809NCT06388733Map
MEMaineHealth Maine Medical Center CareSouth Portland04106NCT06388733Map
MABrigham & Women's HospitalBoston02115NCT04812366Map
MAGSK Investigational SiteBoston02115NCT04641247Map
MATufts Medical CenterBoston02111NCT06388733Map
MIUniversity of Michigan HealthAnn Arbor48109-5946NCT04812366Map
MIUniversity of Michigan Rogel Cancer CenterAnn Arbor48109NCT06388733Map
MIGSK Investigational SiteGrand Rapids60637-1470NCT04641247Map
MIHerbert-Herman Cancer Center, Sparrow HospitalLansing48912NCT01042379Map
MNAllina HealthMinneapolis55407NCT06388733Map
MNUniversity of MinnesotaMinneapolis55455NCT01042379Map
MNUniversity of Minnesota Health Clinics and Surgery Center, MinneapolisMinneapolis55455NCT06388733Map
MNMayo ClinicRochester55905NCT01042379Map
MNMetro Minnesota Community Oncology Research Consortium, Hennepin County Medical CenterSaint Louis Park55416NCT01042379Map
MOSaint Lukes Neuro OncologyKansas City64111NCT06388733Map
MOWashington University School of Medicine in St. LouisSt Louis63110NCT06915025Map
MOWashington University, School of MedicineSt Louis63110NCT06388733Map
NJGSK Investigational SiteMorristown07962-1956NCT04641247Map
NJJersey Shore University Medical CenterNeptune City07753NCT06388733Map
NJRutgers Cancer Institute of New JerseyNew Brunswick08903NCT01042379Map
NJAtlantic Health SystemSummit07901NCT06388733Map
NYRoswell Park Cancer InstituteBuffalo14263NCT01042379Map
NYGSK Investigational SiteLake Success11042NCT04641247Map
NYNorthwell HealthNew Hyde Park11042NCT06388733Map
NYColumbia University Medical CenterNew York10032NCT01042379Map
NYLaura and Isaac Perlmutter Cancer Center / NYU Langone HealthNew York10016NCT01042379Map
NYNew York University Ambulatory Care CenterNew York10016NCT06388733Map
NYUniversity of Rochester Wilmot Cancer InstituteRochester14642NCT01042379Map
NYMontefiore Medical CenterThe Bronx10467NCT01042379Map
NYMontefiore Medical CenterThe Bronx10461NCT06388733Map
NCGSK Investigational SiteCharlotte28204NCT04641247Map
NCDuke Cancer Center Brain Tumor ClinicDurham27710NCT06388733Map
NCWake Forest Baptist Comprehensive Cancer CenterWinston-Salem27157NCT01042379Map
NCWake Forest Baptist HealthWinston-Salem27157NCT06388733Map
OHUniversity of Cincinnati Cancer InstituteCincinnati45267NCT06388733Map
OHCleveland ClinicCleveland44106NCT01042379Map
OHThe Cleveland Clinic FoundationCleveland44195NCT06388733Map
OHThe Ohio State UniversityColumbus43210NCT06388733Map
OHThe Ohio State University, Stefanie Spielman Comprehensive Breast CenterColumbus43212NCT01042379Map
OROregon Health & Science Institute (OHSU)Portland97239NCT01042379Map
ORProvidence Cancer InstitutePortland97213NCT06915025Map
ORProvidence Portland Medical CenterPortland97213NCT06388733Map
PAThomas Jefferson UniversityPhiladelphia19107NCT06388733Map
PAUniversity of Pennsylvania (U Penn)Philadelphia19104NCT01042379Map
PAUniversity of Pennsylvania, Abramson Cancer CenterPhiladelphia19104NCT06747845Map
PAUniversity of Pittsburgh Medical Center Health SystemPittsburgh15232NCT06388733Map
SCMedical University of South Carolina - Department of NeurosurgeryCharleston29425NCT06388733Map
SDSanford Clinical ResearchSioux Falls57104NCT01042379Map
SDSanford HealthSioux Falls57104NCT06915025Map
TNErlanger HealthChattanooga37403NCT06915025Map
TXM D Anderson Cancer CenterHouston77030NCT04947254Map
TXM D Anderson Cancer CenterHouston77030NCT05700721Map
TXMD Anderson Cancer CenterHouston77030NCT05526989Map
TXU.T. MD Anderson Cancer CenterHouston77030NCT04812366Map
TXBaylor Scott & White HealthTemple76508NCT06388733Map
UTHuntsman Cancer Institute, University of UtahSalt Lake City84112NCT01042379Map
VTThe University of Vermont Medical CenterBurlington05401NCT06388733Map
WAFred Hutchinson Cancer CenterSeattle98109NCT04812366Map
WAUniversity of Washington Medical CenterSeattle98109NCT06388733Map
WAProvidence Sacred Heart Medical Center & Children's HospitalSpokane99204NCT06915025Map
WIUniversity of Wisconsin Cancer CenterMadison53706NCT06388733Map
WIFroedtert and The Medical College of WisconsinMilwaukee53226NCT06915025Map

Niraparib clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletedterminatedwithdrawnnot yet recruitingunknownapproved for marketingTotal
Early P1224
P1161654335
P1/P2357232123
P2201723117220100
P2/P3112
P357311118
P4111115
N/A2611212

Recruiting Niraparib clinical trials (39)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT06915025OVATION-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 CancerP3Epithelial Ovarian Cancer500Jul 2025
NCT05183984NIRVANA-1Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian CancerP2Ovarian Cancer390Feb 2022
NCT05009082Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian CancerP3Ovarian Cancer970Sep 2022
NCT01042379I-SPYI-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast CancerP2Breast Neoplasms5,000Mar 2010
NCT06412120Study Evaluating Safety, Tolerability, and Metabolism of NiraparibP4Ovarian Cancer70Aug 2026
NCT05232006PALB2-PARPi-01PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations CarriersP2Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers12May 2022
NCT04341181ProTargetProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic ProfilingP2Cancer300Aug 2020
NCT05700721STARLETPhase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)P2Brain Metastases120Jun 2023
NCT06953323A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid TumorsP1/P2Advanced Solid Tumor86Jul 2025
NCT06682780A Phase I/II Study of LM-2417 in Subjects With Advanced Solid TumoursP1/P2Advanced Solid Tumor320Sep 2025
NCT03651206ROCSANRecurrent Ovarian CarcinoSarcoma Anti-pd-1 NiraparibP2/P3Ovarian Carcinosarcoma138Jul 2020
NCT06747845ParpVax2Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based ChemotherapyP2Pancreatic Adenocarcinoma Metastatic68May 2025
NCT04423185PLATFORM Study of Precision Medicine for Rare TumorsP2Rare Tumor770Aug 2020
NCT05615818SAFIR-ABC10Personalized Medicine for Advanced Biliary Cancer PatientsP3Biliary Tract Neoplasms800Jul 2024
NCT05601440Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast CancerP2Breast Cancer484Jun 2023
NCT04681469PRIMEInduction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCCP2Head and Neck Squamous Cell Carcinoma49Feb 2021
NCT07059676LIBINI-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 CancerAdvanced Ovarian Cancer120Jul 2025
NCT06388733A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated GlioblastomaP3Glioblastoma450Jun 2024
NCT06180356ANALLISANiraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic ProgressionP2Ovarian Cancer30Dec 2024
NCT05694715Combination Therapy in Cancers With Mutations in DNA Repair GenesP1Metastatic Solid Tumor24May 2023
NCT05519670CAPRICEA Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCErP1/P2Breast Cancer72Mar 2023
NCT02925234DRUPThe Drug Rediscovery Protocol (DRUP Trial)P2Cancer1,550Aug 2016
NCT05526989Study of the Combination Dostarlimab With Niraparib In Patients With Penile CarcinomaP2Penile Carcinoma25Dec 2022
NCT06258018ONC-2022-001Niraparib and Temozolomide in Patients GlioblastomaP1/P2Glioma, Malignant86Sep 2024
NCT06141265BRANDNiraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + BevacizumabP2Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma116Nov 2023
NCT05961124Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian CancerP2Ovarian Cancer40Aug 2023
NCT06594679NICHOLA Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)P1/P2Ovarian Cancer73Sep 2024
NCT05990192SOPRANOSBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi TherapyP2Ovarian Cancer Recurrent42Jun 2024
NCT06237205Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination DeficiencyP2Efficacy33Feb 2024
NCT05718323RAISENiraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLCP2SCLC,Extensive Stage44Dec 2023
NCT04716686Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous CarcinomaP2Endometrial Carcinoma83Jun 2021
NCT03983226Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)P2Ovarian Cancer Recurrent167Oct 2019
NCT03903835ProBioProBio: A Biomarker Driven Study in Patients With Metastatic Prostate CancerP3Metastatic Castration-resistant Prostate Cancer (mCRPC)750Feb 2019
NCT04641247A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib StudyP2Ovarian Neoplasms30Apr 2021
NCT06887933A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian CancerP4Ovarian Neoplasms67Apr 2025
NCT04947254Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate CancerP2Prostate Carcinoma200Aug 2021
NCT04812366GUNSGenomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate CancerP2Prostate Cancer315Sep 2021
NCT06614790NIRAPARIBNiraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.Ovarian Cancer300Sep 2024
NCT06827353OVNI-BNiraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination DeficiencyOvarian Carcinoma300Oct 2020

Niraparib clinical trials by indication

Ovarian Cancer (29)

NCTAcronymPhaseStatusTitle
NCT05183984NIRVANA-1P2recruitingNiraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer
NCT05009082P3recruitingNiraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
NCT06412120P4recruitingStudy Evaluating Safety, Tolerability, and Metabolism of Niraparib
NCT06161493P1withdrawnZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors
NCT06180356ANALLISAP2recruitingNiraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression
NCT05961124P2recruitingAlternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer
NCT06594679NICHOLP1/P2recruitingA Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)
NCT04507841P2active not recruitingNiraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer
+ 21 more, see All trials below.

Ovarian Neoplasms (13)

NCTAcronymPhaseStatusTitle
NCT03602859FIRSTP3active not recruitingA 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
NCT04641247P2recruitingA Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
NCT06887933P4not yet recruitingA Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer
NCT02655016GSK3985771P3active not recruitingA Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
NCT06964165COHORT-CP2terminatedA Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)
NCT03574779OPALP2completedA Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer
NCT03326193P2completedA Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
NCT05734911N/AcompletedEffectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study
+ 5 more, see All trials below.

Neoplasms (7)

NCTAcronymPhaseStatusTitle
NCT03981796RUBYP3active not recruitingA Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
NCT06077877PKP1/P2active not recruitingA Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors
NCT04544995SCOOPP1terminatedDose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)
NCT03307785P1completedStudy of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042
NCT03329001P1completedCrossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule
NCT02657889TOPACIOP1/P2completedNiraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer
NCT03308942PD-1P2completedEffects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants

Breast Cancer (7)

NCTAcronymPhaseStatusTitle
NCT04837209NADiRP2active not recruitingRadiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer
NCT05601440P2recruitingLiquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
NCT05519670CAPRICEP1/P2not yet recruitingA Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr
NCT04762901P1withdrawnLCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer
NCT04240106LUZERNP2completedNiraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)
NCT03154281P1completedEvaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast
NCT02826512P2terminatedA Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients

Epithelial Ovarian Cancer (6)

NCTAcronymPhaseStatusTitle
NCT06915025OVATION-3P3recruitingPhase 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
NCT05187208POLOP4unknownPARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer
NCT04986371RENI-1N/AunknownReal-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer
NCT05385068tP2unknownA Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi
NCT06086665REFIRMN/AcompletedThe Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer
NCT04546373N/AcompletedNiraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer

Cancer (5)

NCTAcronymPhaseStatusTitle
NCT04341181ProTargetP2recruitingProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling
NCT03768063IMbrella BP3active not recruitingA Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
NCT02925234DRUPP2recruitingThe Drug Rediscovery Protocol (DRUP Trial)
NCT04774406N/AcompletedArterial Hypertension Related to PARP Inhibitors (ArteRIB)
NCT02476552P1completedAbsorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer

Advanced Solid Tumor (4)

NCTAcronymPhaseStatusTitle
NCT06953323P1/P2recruitingA Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors
NCT06682780P1/P2recruitingA Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
NCT04502602iNNOVATEP1active not recruitingNiraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer
NCT04655183P1/P2withdrawnStudy of M4344 in Combination With Niraparib

Prostate Cancer (4)

NCTAcronymPhaseStatusTitle
NCT06212583KNIGHTSP2active not recruitingHigh-Risk Metachronous Oligometastatic Prostate Cancer Trial
NCT04194554ASCLEPIuSP1/P2active not recruitingA Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
NCT06527690REPRESENTATIONP2withdrawnRace Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer
NCT04812366GUNSP2recruitingGenomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

Ovarian Cancer Recurrent (3)

NCTAcronymPhaseStatusTitle
NCT05990192SOPRANOP2recruitingSBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy
NCT04149145PARPP1withdrawnTrial of M4344 and Niraparib in Patients With Poly (ADP-ribose) Polymerase (PARP) Resistant Recurrent Ovarian Cancer
NCT03983226P2recruitingSurgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

Glioblastoma (3)

NCTAcronymPhaseStatusTitle
NCT06388733P3recruitingA Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
NCT05076513Early P1active not recruitingTrial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
NCT04221503P2active not recruitingNiraparib/TTFields in GBM

Endometrial Cancer (3)

NCTAcronymPhaseStatusTitle
NCT05289648NIRECEarly P1withdrawnNiraparib in High-grade Endometrial Cancer Trial
NCT03016338P2unknownStudy of Niraparib and TSR-042 in Recurrent Endometrial Cancer
NCT04080284P2completedTrial of Maintenance With Niraparib- Uterine Serous Carcinoma

Recurrent Ovarian Cancer (3)

NCTAcronymPhaseStatusTitle
NCT05335993P2active not recruitingA Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.
NCT05126342P2withdrawnStudy to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi
NCT03025867N/Aapproved for marketingExpanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

Recurrent Glioblastoma (3)

NCTAcronymPhaseStatusTitle
NCT05297864OU-SCC-PI-4GP2terminatedPARP Inhibition for Gliomas (PI-4G or π4g)
NCT05666349RiNGP1withdrawnReirradiation and Niraparib in Patients With Recurrent Glioblastoma
NCT04715620P2unknownNiraparib Combined With Radiotherapy in rGBM

Solid Tumor (3)

NCTAcronymPhaseStatusTitle
NCT04185831MEGALiTP2active not recruitingA MolEcularly Guided Anti-Cancer Drug Off-Label Trial
NCT05169437PAVOP2terminatedNiraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
NCT04235101P1completedPhase I Study of SYD985 With Niraparib in Patients With Solid Tumors

Neoplasms, Breast (3)

NCTAcronymPhaseStatusTitle
NCT04915755ZESTP3active not recruitingEfficacy 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
NCT01905592BRAVOP3terminatedA Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
NCT03329937P1completedStudy Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer

Prostatic Neoplasms (3)

NCTAcronymPhaseStatusTitle
NCT04577833AAP1active not recruitingA Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
NCT02854436GalahadP2completedAn Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
NCT02924766BEDIVEREP1completedA Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

Pancreatic Cancer (3)

NCTAcronymPhaseStatusTitle
NCT03601923P2completedNiraparib in Patients With Pancreatic Cancer
NCT03553004NIRA-PANCP2unknownNiraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial
NCT04409002P2completedNiraparib + Dostarlimab + RT in Pancreatic Cancer

Metastatic Prostate Cancer (2)

NCTAcronymPhaseStatusTitle
NCT06329830LUNAARP1/P2withdrawn177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer
NCT02500901CRPCP1terminatedEnzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)

Head and Neck Squamous Cell Carcinoma (2)

NCTAcronymPhaseStatusTitle
NCT05784012RADIANP1/P2active not recruitingTwo-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma
NCT04681469PRIMEP2recruitingInduction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC

Mesothelioma, Malignant (2)

NCTAcronymPhaseStatusTitle
NCT05455424NEROP2completedNiraparib Efficacy in Patient With Unresectable Mesothelioma
NCT03654833MiSTP2unknownMesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma

Ovarian Carcinoma (2)

NCTAcronymPhaseStatusTitle
NCT06827353OVNI-BN/ArecruitingNiraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency
NCT05311579P2unknownNiraparib Plus Anlotinib for Recurrent Ovarian Cancer

Endometrial Carcinoma (2)

NCTAcronymPhaseStatusTitle
NCT04716686P2recruitingNiraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma
NCT04159155CAN-STAMPP2/P3terminatedA Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer

Lung Cancer (2)

NCTAcronymPhaseStatusTitle
NCT04940637UNITO-001P2unknownUNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC
NCT03891615P1unknownNiraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer

Prostate Adenocarcinoma (2)

NCTAcronymPhaseStatusTitle
NCT04037254P1/P2completedTesting 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
NCT04288687P2completedA Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects

Urothelial Carcinoma (2)

NCTAcronymPhaseStatusTitle
NCT03869190MORPHEUS-UCP1/P2completedStudy Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
NCT03945084P2completedMaintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy

Metastatic Hormone-sensitive Prostate Cancer (mHSPC) (1)

NCTAcronymPhaseStatusTitle
NCT06392841HARMONYP2withdrawnNiraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations

Advanced Ovarian Cancer (1)

NCTAcronymPhaseStatusTitle
NCT07059676LIBINI-1N/Anot yet recruitingDesign 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)

NCTAcronymPhaseStatusTitle
NCT06747845ParpVax2P2recruitingMaintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy

Platinum-Resistant Fallopian Tube Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05672095P1/P2withdrawnNiraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer

MMR-D/MSI-H Colorectal Cancers (1)

NCTAcronymPhaseStatusTitle
NCT06365970P2withdrawnNiraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers

Glioma, Malignant (1)

NCTAcronymPhaseStatusTitle
NCT06258018ONC-2022-001P1/P2not yet recruitingNiraparib and Temozolomide in Patients Glioblastoma

Biliary Tract Neoplasms (1)

NCTAcronymPhaseStatusTitle
NCT05615818SAFIR-ABC10P3recruitingPersonalized Medicine for Advanced Biliary Cancer Patients

Castration-Resistant Prostate Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05689021P2active not recruitingCJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations

Efficacy (1)

NCTAcronymPhaseStatusTitle
NCT06237205P2not yet recruitingGenome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency

SCLC,Extensive Stage (1)

NCTAcronymPhaseStatusTitle
NCT05718323RAISEP2recruitingNiraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC

Locally Advanced Leiomyosarcoma (1)

NCTAcronymPhaseStatusTitle
NCT05174455P2withdrawnNiraparib for the Treatment of Leiomyosarcoma

Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT06141265BRANDP2recruitingNiraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab

Recurrent Endometrial Serous Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05870761P2active not recruitingCombination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

Metastatic Colorectal Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05412706BohèmeP2withdrawnNiraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy

Brain Metastases (1)

NCTAcronymPhaseStatusTitle
NCT05700721STARLETP2recruitingPhase 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)

NCTAcronymPhaseStatusTitle
NCT05694715P1recruitingCombination Therapy in Cancers With Mutations in DNA Repair Genes

Low-grade Glioma (1)

NCTAcronymPhaseStatusTitle
NCT05406700Early P1active not recruitingNiraparib In Recurrent IDH 1/2 Gliomas

Recurrent Endometrial Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05523440P2terminatedBevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation

Advanced Breast Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05238831ACTEarly P1withdrawnSMMART Adaptive Clinical Treatment (ACT) Trial

Penile Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05526989P2recruitingStudy of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma

Metastatic Pancreatic Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05442749PARPi-PANCP2terminatedNiraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer

Homologous Recombination Deficiency (1)

NCTAcronymPhaseStatusTitle
NCT05461690P2unknownPhase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency

Sarcoma,Soft Tissue (1)

NCTAcronymPhaseStatusTitle
NCT05515575P2active not recruitingA Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA

Rectal Neoplasms (1)

NCTAcronymPhaseStatusTitle
NCT04926324P1/P2terminatedA Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers

Recurrent Small Cell Lung Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05162196P2unknownThe 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)

NCTAcronymPhaseStatusTitle
NCT05232006PALB2-PARPi-01P2not yet recruitingPARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers

Metastatic Cancer (1)

NCTAcronymPhaseStatusTitle
NCT04992013P2active not recruitingNiraparib in Tumors Metastatic to the CNS

HER2-negative Metastatic Breast Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05261269P1completedA 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)

NCTAcronymPhaseStatusTitle
NCT05130515CC-ANNIEP2completedAnlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.

Anatomic Stage III Breast Cancer AJCC v8 (1)

NCTAcronymPhaseStatusTitle
NCT04673448P1active not recruitingNiraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer

HRD (1)

NCTAcronymPhaseStatusTitle
NCT04895046P2withdrawnMaintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

Advanced Cancer (1)

NCTAcronymPhaseStatusTitle
NCT04991480P1completedA Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors

Prostate Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT04947254P2recruitingAndrogen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer

Nasopharyngeal Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05162872P2unknownNiraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal Carcinoma

Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor (1)

NCTAcronymPhaseStatusTitle
NCT04734665NIRVANA-RP2unknownNiraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor

Recurrent/ Advanced Stage Endometrial Cancer Patients (1)

NCTAcronymPhaseStatusTitle
NCT04885413P2unknownAn 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)

NCTAcronymPhaseStatusTitle
NCT04481113P1completedAbemaciclib 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)

NCTAcronymPhaseStatusTitle
NCT04861181NIRAPKP4terminatedNIRAPK : 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)

NCTAcronymPhaseStatusTitle
NCT04779151NIRADOP2terminatedBasket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab

HER2-negative Breast Cancer (1)

NCTAcronymPhaseStatusTitle
NCT04764084HRRP1unknownNiraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors

Lung Small Cell Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT04701307P2active not recruitingNiraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas

Aggressive Variant Prostate Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT04592237P2active not recruitingCabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer

Metastatic Pancreatic Ductal Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT04493060P2completedNiraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer

Stage I Breast Cancer (1)

NCTAcronymPhaseStatusTitle
NCT04584255P2active not recruitingNiraparib + Dostarlimab In BRCA Mutated Breast Cancer

Head and Neck Cancer (1)

NCTAcronymPhaseStatusTitle
NCT04313504TSR-042P2completedStudy Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

Lung Cancer, Non-Small Cell (1)

NCTAcronymPhaseStatusTitle
NCT04475939ZEAL-1LP3completedPlacebo-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)

NCTAcronymPhaseStatusTitle
NCT04497844AMPLITUDEP3active not recruitingA 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)

NCTAcronymPhaseStatusTitle
NCT04508803CHANGEABLEP2completedCombination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer

Rare Tumor (1)

NCTAcronymPhaseStatusTitle
NCT04423185P2recruitingPLATFORM Study of Precision Medicine for Rare Tumors

Ovarian Carcinosarcoma (1)

NCTAcronymPhaseStatusTitle
NCT03651206ROCSANP2/P3recruitingRecurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

Platinum-resistant Ovarian Cancer (1)

NCTAcronymPhaseStatusTitle
NCT04376073ANNIEP2unknownAnlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer

Cervical Cancer (1)

NCTAcronymPhaseStatusTitle
NCT04395612CQGOG0101P2unknownNiraparib Combined With Brivanib or Toripalimab in Patients With Cervical Cancer

Recurrent Cervix Cancer (1)

NCTAcronymPhaseStatusTitle
NCT04068753STARP2active not recruitingNiraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer

Advanced Solid Tumors (Excluding Prostate Cancer) (1)

NCTAcronymPhaseStatusTitle
NCT04267939BAY1895344P1terminatedATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer

ATM Gene Mutation (1)

NCTAcronymPhaseStatusTitle
NCT04030559P2terminatedNiraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects

Gastric Cancer (1)

NCTAcronymPhaseStatusTitle
NCT04178460P1terminatedA 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)

NCTAcronymPhaseStatusTitle
NCT04170153M1774P1active not recruitingTuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)

Advanced Microsatellite Stable Colorectal Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT03983993NIPAVectP2active not recruitingNiraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

Urothelial Cancer (1)

NCTAcronymPhaseStatusTitle
NCT03425201NICARAGUAP1/P2completedNiraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA)

Metastatic Breast Cancer (1)

NCTAcronymPhaseStatusTitle
NCT03368729P1/P2active not recruitingNiraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

Triple Negative Breast Cancer (1)

NCTAcronymPhaseStatusTitle
NCT03945721UNITYP1active not recruitingA Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients

Esophageal Cancer (1)

NCTAcronymPhaseStatusTitle
NCT03840967P2terminatedA Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma

Deleterious BRCA1 Gene Mutation (1)

NCTAcronymPhaseStatusTitle
NCT03586661P1active not recruitingNiraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Metastatic Melanoma (1)

NCTAcronymPhaseStatusTitle
NCT03925350HRP2unknownEfficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation

Advanced Malignant Solid Neoplasm (1)

NCTAcronymPhaseStatusTitle
NCT03830918P1/P2active not recruitingNiraparib, 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)

NCTAcronymPhaseStatusTitle
NCT03903835ProBioP3recruitingProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

Castration-Resistant Prostatic Cancer (1)

NCTAcronymPhaseStatusTitle
NCT03748641MAGNITUDEP3active not recruitingA 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)

NCTAcronymPhaseStatusTitle
NCT03695380P1completedA 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)

NCTAcronymPhaseStatusTitle
NCT03598270ANITAP3completedPlatinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer

Ovarian Neoplasm (1)

NCTAcronymPhaseStatusTitle
NCT05751629COHORT-AP2completedStudy to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer

Mesothelioma (1)

NCTAcronymPhaseStatusTitle
NCT03207347DDRP2completedA Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)

Advanced Solid Tumors (1)

NCTAcronymPhaseStatusTitle
NCT03497429P1completedA Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors

Prostatic Neoplasms, Castration-Resistant (1)

NCTAcronymPhaseStatusTitle
NCT03431350QUESTP2active not recruitingA Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Pancreatic Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT03404960ParpvaxP1/P2completedNiraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy

Carcinoma, Squamous Cell of Head and Neck (1)

NCTAcronymPhaseStatusTitle
NCT03088059UPSTREAMP2unknownBiomarker-based Study in R/M SCCHN

Solid Tumor, Adult (1)

NCTAcronymPhaseStatusTitle
NCT03209401P1terminatedNiraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies

Prostate Carcinoma Metastatic to the Bone (1)

NCTAcronymPhaseStatusTitle
NCT03076203P1completedPhase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad)

Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT03221400P1/P2unknownPEN-866 in Patients With Advanced Solid Malignancies

Ewing Sarcoma (1)

NCTAcronymPhaseStatusTitle
NCT02044120P1completedESP1/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)

NCTAcronymPhaseStatusTitle
NCT01042379I-SPYP2recruitingI-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Metastatic Castration-resistant Prostate Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05401214N/Aapproved for marketingPre-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.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
POLONCT05187208P4unknownEpithelial Ovarian Cancer102
NIRAPKNCT04861181P4terminatedAdult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer12
NiQoLeNCT03752216P4completedOvarian Cancer141PMID 39673810
OVATION-3NCT06915025P3recruitingEpithelial Ovarian Cancer500
FIRSTNCT03602859P3active not recruitingOvarian Neoplasms1,400
IMbrella BNCT03768063P3active not recruitingCancer1,000
SAFIR-ABC10NCT05615818P3recruitingBiliary Tract Neoplasms800
AMPLITUDENCT04497844P3active not recruitingMetastatic Castration-sensitive Prostate Cancer696PMID 41057655
MAGNITUDENCT03748641P3active not recruitingCastration-Resistant Prostatic Cancer765PMID 42015879
ProBioNCT03903835P3recruitingMetastatic Castration-resistant Prostate Cancer (mCRPC)750PMID 39164518
RUBYNCT03981796P3active not recruitingNeoplasms785PMID 37731489
GSK3985771NCT02655016P3active not recruitingOvarian Neoplasms733PMID 39013265
ZEAL-1LNCT04475939P3completedLung Cancer, Non-Small Cell666PMID 34478166
ZESTNCT04915755P3active not recruitingNeoplasms, Breast40
NItCHE-MITO33NCT04679064P3unknownOvarian Cancer427PMID 34607820
ANITANCT03598270P3completedRecurrent Ovarian Carcinoma417PMID 33318079
BRAVONCT01905592P3terminatedNeoplasms, Breast216
NIRVANA-1NCT05183984P2recruitingOvarian Cancer390PMID 37650734
I-SPYNCT01042379P2recruitingBreast Neoplasms5,000PMID 21796368
PALB2-PARPi-01NCT05232006P2not yet recruitingMetastatic Breast Cancer in Germline-PALB2 Mutations Carriers12
ProTargetNCT04341181P2recruitingCancer300PMID 36814246
KNIGHTSNCT06212583P2active not recruitingProstate Cancer88
STARLETNCT05700721P2recruitingBrain Metastases120
NADiRNCT04837209P2active not recruitingBreast Cancer32
HARMONYNCT06392841P2withdrawnMetastatic Hormone-sensitive Prostate Cancer (mHSPC)0
ParpVax2NCT06747845P2recruitingPancreatic Adenocarcinoma Metastatic68
PRIMENCT04681469P2recruitingHead and Neck Squamous Cell Carcinoma49
REPRESENTATIONNCT06527690P2withdrawnProstate Cancer0
ANALLISANCT06180356P2recruitingOvarian Cancer30
DRUPNCT02925234P2recruitingCancer1,550PMID 37424386
BRANDNCT06141265P2recruitingOvarian, Fallopian Tube and Primary Peritoneal Carcinoma116
STARNCT04068753P2active not recruitingRecurrent Cervix Cancer66
SOPRANONCT05990192P2recruitingOvarian Cancer Recurrent42
RAISENCT05718323P2recruitingSCLC,Extensive Stage44
QUESTNCT03431350P2active not recruitingProstatic Neoplasms, Castration-Resistant136
NIPAVectNCT03983993P2active not recruitingAdvanced Microsatellite Stable Colorectal Carcinoma26
GUNSNCT04812366P2recruitingProstate Cancer315
TSR-042NCT04313504P2completedHead and Neck Cancer10
UPSTREAMNCT03088059P2unknownCarcinoma, Squamous Cell of Head and Neck340PMID 30307465
UNITO-001NCT04940637P2unknownLung Cancer70
COHORT-CNCT06964165P2terminatedOvarian Neoplasms36
OPALNCT03574779P2completedOvarian Neoplasms77PMID 38754056
NIRADONCT04779151P2terminatedUrothelial Bladder Cancer51
NIRA-PANCNCT03553004P2unknownPancreatic Cancer18PMID 37759489
NERONCT05455424P2completedMesothelioma, Malignant88PMID 37993149
MEGALiTNCT04185831P2active not recruitingSolid Tumor167
tNCT05385068P2unknownEpithelial Ovarian Cancer35
NewtonNCT03891576P2terminatedOvarian Cancer83PMID 41950571
PARPi-PANCNCT05442749P2terminatedMetastatic Pancreatic Cancer2
PAVONCT05169437P2terminatedSolid Tumor22
NIRVANA-RNCT04734665P2unknownPlatinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor44PMID 34910393
OU-SCC-PI-4GNCT05297864P2terminatedRecurrent Glioblastoma15
LUZERNNCT04240106P2completedBreast Cancer14
MiSTNCT03654833P2unknownMesothelioma, Malignant186PMID 35157829
NEOPRIMANCT04284852P2completedOvarian Cancer20
BohèmeNCT05412706P2withdrawnMetastatic Colorectal Cancer0
EUDARIONCT03783949P2completedOvarian Cancer122
GalahadNCT02854436P2completedProstatic Neoplasms289PMID 35131040
CHANGEABLENCT04508803P2completedTreatment Efficacy37
HRNCT03925350P2unknownMetastatic Melanoma41PMID 40373259
CC-ANNIENCT05130515P2completedPlatinum-resistant Recurrent Clear Cell Ovarian Cancer6
AVANIRA3NCT04556071P2unknownOvarian Neoplasms32
DDRNCT03207347P2completedMesothelioma37PMID 39626160
CQGOG0101NCT04395612P2unknownCervical Cancer38PMID 25651787
COHORT-ANCT05751629P2completedOvarian Neoplasm41
ANNIENCT04376073P2unknownPlatinum-resistant Ovarian Cancer40PMID 36583171
MOONSTONENCT03955471P2terminatedOvarian Neoplasms41PMID 37890345
PD-1NCT03308942P2completedNeoplasms53
QUADRANCT02354586P2completedOvarian Neoplasms463PMID 30948273

Terminated and withdrawn Niraparib trials (38)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

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 IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT06915025OVATION-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 CancerP3recruiting500ImunonJul 2025
NCT05183984NIRVANA-1Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian CancerP2recruiting390ARCAGY/ GINECO GROUPFeb 2022
NCT05009082Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian CancerP3recruiting970AGO Study GroupSep 2022
NCT01042379I-SPYI-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast CancerP2recruiting5,000QuantumLeap Healthcare CollaborativeMar 2010
NCT06412120Study Evaluating Safety, Tolerability, and Metabolism of NiraparibP4recruiting70University of MiamiAug 2026
NCT05232006PALB2-PARPi-01PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations CarriersP2not yet recruiting12Assistance Publique - Hôpitaux de ParisMay 2022
NCT04341181ProTargetProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic ProfilingP2recruiting300Ulrik LassenAug 2020
NCT06212583KNIGHTSHigh-Risk Metachronous Oligometastatic Prostate Cancer TrialP2active not recruiting88University of Maryland, BaltimoreApr 2024
NCT06161493ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid TumorsP1withdrawn0Haider MahdiJan 2024
NCT05700721STARLETPhase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)P2recruiting120M.D. Anderson Cancer CenterJun 2023
NCT06953323A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid TumorsP1/P2recruiting86Wigen Biomedicine Technology (Shanghai) Co., Ltd.Jul 2025
NCT06682780A Phase I/II Study of LM-2417 in Subjects With Advanced Solid TumoursP1/P2recruiting320LaNova Medicines LimitedSep 2025
NCT04837209NADiRRadiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast CancerP2active not recruiting32Massachusetts General HospitalJul 2021
NCT04584255Niraparib + Dostarlimab In BRCA Mutated Breast CancerP2active not recruiting62Dana-Farber Cancer InstituteDec 2020
NCT04194554ASCLEPIuSA Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate CancerP1/P2active not recruiting102University of Michigan Rogel Cancer CenterNov 2020
NCT03602859FIRSTA 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 CancerP3active not recruiting1,400Tesaro, Inc.Oct 2018
NCT05784012RADIANTwo-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell CarcinomaP1/P2active not recruiting34Grupo Español de Tratamiento de Tumores de Cabeza y CuelloNov 2023
NCT03651206ROCSANRecurrent Ovarian CarcinoSarcoma Anti-pd-1 NiraparibP2/P3recruiting138ARCAGY/ GINECO GROUPJul 2020
NCT06392841HARMONYNiraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair AlterationsP2withdrawn0Qian QinOct 2025
NCT06747845ParpVax2Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based ChemotherapyP2recruiting68Abramson Cancer Center at Penn MedicineMay 2025
NCT03945721UNITYA Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer PatientsP1active not recruiting21Massachusetts General HospitalJul 2019
NCT06329830LUNAAR177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate CancerP1/P2withdrawn0Baptist Health South FloridaOct 2024
NCT03768063IMbrella BA Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab StudyP3active not recruiting1,000Hoffmann-La RocheFeb 2019
NCT04423185PLATFORM Study of Precision Medicine for Rare TumorsP2recruiting770Cancer Institute and Hospital, Chinese Academy of Medical SciencesAug 2020
NCT05615818SAFIR-ABC10Personalized Medicine for Advanced Biliary Cancer PatientsP3recruiting800UNICANCERJul 2024
NCT05601440Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast CancerP2recruiting484Canadian Cancer Trials GroupJun 2023
NCT04681469PRIMEInduction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCCP2recruiting49Gruppo Oncologico del Nord-OvestFeb 2021
NCT07059676LIBINI-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 Cancernot yet recruiting120Clinica Universidad de Navarra, Universidad de NavarraJul 2025
NCT06388733A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated GlioblastomaP3recruiting450Ivy Brain Tumor CenterJun 2024
NCT06527690REPRESENTATIONRace Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate CancerP2withdrawn0Latin American Cooperative Oncology GroupApr 2025
NCT06365970Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal CancersP2withdrawn0Ibrahim Halil SahinJan 2025
NCT06180356ANALLISANiraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic ProgressionP2recruiting30MedSIRDec 2024
NCT05694715Combination Therapy in Cancers With Mutations in DNA Repair GenesP1recruiting24University of California, San FranciscoMay 2023
NCT05519670CAPRICEA Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCErP1/P2not yet recruiting72Institut Paoli-CalmettesMar 2023
NCT04592237Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate CancerP2active not recruiting120M.D. Anderson Cancer CenterDec 2020
NCT02925234DRUPThe Drug Rediscovery Protocol (DRUP Trial)P2recruiting1,550The Netherlands Cancer InstituteAug 2016
NCT05335993A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.P2active not recruiting10CanariaBio Inc.Jul 2022
NCT03368729Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast CancerP1/P2active not recruiting46University of Alabama at BirminghamSep 2019
NCT05526989Study of the Combination Dostarlimab With Niraparib In Patients With Penile CarcinomaP2recruiting25H. Lee Moffitt Cancer Center and Research InstituteDec 2022
NCT04497844AMPLITUDEA 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)P3active not recruiting696Janssen Research & Development, LLCSep 2020
NCT04502602iNNOVATENiraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian CancerP1active not recruiting18Virginia Commonwealth UniversityAug 2020
NCT06258018ONC-2022-001Niraparib and Temozolomide in Patients GlioblastomaP1/P2not yet recruiting86Armando Santoro, MDSep 2024
NCT06141265BRANDNiraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + BevacizumabP2recruiting116Peking University Cancer Hospital & InstituteNov 2023
NCT05961124Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian CancerP2recruiting40Sunnybrook Health Sciences CentreAug 2023
NCT06594679NICHOLA Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)P1/P2recruiting73Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoSep 2024
NCT04068753STARNiraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix CancerP2active not recruiting66University of OklahomaFeb 2020
NCT05990192SOPRANOSBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi TherapyP2recruiting42Institute of Cancer Research, United KingdomJun 2024
NCT06237205Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination DeficiencyP2not yet recruiting33Korea University Anam HospitalFeb 2024
NCT05718323RAISENiraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLCP2recruiting44ETOP IBCSG Partners FoundationDec 2023
NCT04992013Niraparib in Tumors Metastatic to the CNSP2active not recruiting20Massachusetts General HospitalApr 2022
NCT04149145PARPTrial of M4344 and Niraparib in Patients With Poly (ADP-ribose) Polymerase (PARP) Resistant Recurrent Ovarian CancerP1withdrawn0University of Alabama at BirminghamMay 2023
NCT04701307Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine CarcinomasP2active not recruiting48M.D. Anderson Cancer CenterFeb 2021
NCT05076513Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent GliomaEarly P1active not recruiting42Nader SanaiOct 2021
NCT03748641MAGNITUDEA Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate CancerP3active not recruiting765Janssen Research & Development, LLCJan 2019
NCT03830918Niraparib, 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 ChemotherapyP1/P2active not recruiting59Jonsson Comprehensive Cancer CenterMar 2019
NCT04716686Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous CarcinomaP2recruiting83Shandong UniversityJun 2021
NCT04507841Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian CancerP2active not recruiting67Tongji HospitalJan 2021
NCT04577833AAA Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate CancerP1active not recruiting136Janssen Research & Development, LLCNov 2020
NCT03983226Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)P2recruiting167Shanghai Gynecologic Oncology GroupOct 2019
NCT03586661Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube CancerP1active not recruiting31M.D. Anderson Cancer CenterApr 2019
NCT03903835ProBioProBio: A Biomarker Driven Study in Patients With Metastatic Prostate CancerP3recruiting750Karolinska InstitutetFeb 2019
NCT03431350QUESTA Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate CancerP2active not recruiting136Janssen Research & Development, LLCMar 2018
NCT03983993NIPAVectNiraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal CancerP2active not recruiting26Emory UniversityOct 2019
NCT05672095Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian CancerP1/P2withdrawn0City of Hope Medical CenterApr 2025
NCT03981796RUBYA Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial CancerP3active not recruiting785Tesaro, Inc.Jul 2019
NCT04641247A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib StudyP2recruiting30GlaxoSmithKlineApr 2021
NCT05126342Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPiP2withdrawn0AGO Research GmbHNov 2023
NCT05406700Niraparib In Recurrent IDH 1/2 GliomasEarly P1active not recruiting16Massachusetts General HospitalMay 2023
NCT04673448Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal CancerP1active not recruiting18University of WashingtonOct 2021
NCT05515575A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNAP2active not recruiting8Memorial Sloan Kettering Cancer CenterAug 2022
NCT05689021CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene MutationsP2active not recruiting8Mayo ClinicMar 2024
NCT05870761Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous CarcinomaP2active not recruiting8Casey CosgroveOct 2023
NCT04170153M1774Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)P1active not recruiting161EMD Serono Research & Development Institute, Inc.Dec 2019
NCT06887933A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian CancerP4not yet recruiting67GlaxoSmithKlineApr 2025
NCT06077877PKA Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid TumorsP1/P2active not recruiting42GlaxoSmithKlineOct 2023
NCT06433219Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)P2active not recruiting63EMD Serono Research & Development Institute, Inc.Oct 2024
NCT04947254Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate CancerP2recruiting200M.D. Anderson Cancer CenterAug 2021
NCT05238831ACTSMMART Adaptive Clinical Treatment (ACT) TrialEarly P1withdrawn0OHSU Knight Cancer InstituteJan 2023
NCT02655016GSK3985771A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based ChemotherapyP3active not recruiting733Tesaro, Inc.Jul 2016
NCT04812366GUNSGenomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate CancerP2recruiting315University of British ColumbiaSep 2021
NCT05021562A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practicecompleted354TakedaSep 2021
NCT04475939ZEAL-1LPlacebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung CancerP3completed666GlaxoSmithKlineOct 2020
NCT04313504TSR-042Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCCP2completed10Trisha Wise-DraperNov 2020
NCT03601923Niraparib in Patients With Pancreatic CancerP2completed32Dana-Farber Cancer InstituteAug 2018
NCT05289648NIRECNiraparib in High-grade Endometrial Cancer TrialEarly P1withdrawn0Sir Mortimer B. Davis - Jewish General HospitalMay 2024
NCT04762901LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast CancerP1withdrawn0Wake Forest University Health SciencesApr 2021
NCT04221503Niraparib/TTFields in GBMP2active not recruiting30Abramson Cancer Center at Penn MedicineDec 2019
NCT05198804A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian CancerP1/P2completed117K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncJan 2022
NCT06614790NIRAPARIBNiraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.recruiting300Pomeranian Medical University SzczecinSep 2024
NCT05174455Niraparib for the Treatment of LeiomyosarcomaP2withdrawn0David Liebner, MDDec 2023
NCT05187208POLOPARP Inhibitor Oral Maintenance in Low-Risk Ovarian CancerP4unknown102Seoul National University HospitalJan 2022
NCT04915755ZESTEfficacy 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 DiseaseP3active not recruiting40GlaxoSmithKlineJun 2021
NCT03088059UPSTREAMBiomarker-based Study in R/M SCCHNP2unknown340European Organisation for Research and Treatment of Cancer - EORTCNov 2017
NCT03016338Study of Niraparib and TSR-042 in Recurrent Endometrial CancerP2unknown51University Health Network, TorontoNov 2017
NCT04991480A Study of ART4215 for the Treatment of Advanced or Metastatic Solid TumorsP1completed93Artios Pharma LtdSep 2021
NCT04037254Testing 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 RecurringP1/P2completed22NRG OncologyOct 2019
NCT03869190MORPHEUS-UCStudy Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)P1/P2completed272Hoffmann-La RocheJun 2019
NCT04030559Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response DefectsP2terminated11University of California, DavisFeb 2020
NCT06827353OVNI-BNiraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiencyrecruiting300Centre Hospitalier Universitaire de NīmesOct 2020
NCT05461690Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination DeficiencyP2unknown50Zhejiang Cancer HospitalSep 2022
NCT04940637UNITO-001UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLCP2unknown70University of Turin, ItalyDec 2020
NCT04481113Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast CancerP1completed8OHSU Knight Cancer InstituteJun 2021
NCT05065021Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitorP2unknown40University Health Network, TorontoFeb 2023
NCT04493060Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic CancerP2completed22Mayo ClinicDec 2020
NCT05641506A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian CancerP2unknown50Sichuan Cancer Hospital and Research InstituteDec 2022
NCT04159155CAN-STAMPA Study of Various Treatments in Serous or p53 Abnormal Endometrial CancerP2/P3terminated11University Health Network, TorontoNov 2020
NCT04544995SCOOPDose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)P1terminated47GlaxoSmithKlineOct 2020
NCT04861181NIRAPKNIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients.P4terminated12Hospices Civils de LyonMay 2021
NCT06964165COHORT-CA Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)P2terminated36Tesaro, Inc.Apr 2022
NCT03574779OPALA Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian CancerP2completed77Tesaro, Inc.Nov 2018
NCT04986371RENI-1Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancerunknown300Ling-Ying WuAug 2021
NCT04779151NIRADOBasket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and DostarlimabP2terminated51Gustave Roussy, Cancer Campus, Grand ParisApr 2021
NCT03553004NIRA-PANCNiraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 TrialP2unknown18University of Kansas Medical CenterJan 2019
NCT05455424NERONiraparib Efficacy in Patient With Unresectable MesotheliomaP2completed88University Hospital Southampton NHS Foundation TrustJul 2022
NCT05523440Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A MutationP2terminated9University of OklahomaFeb 2023
NCT04679064NItCHE-MITO33Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum RetreatmentP3unknown427Fondazione Policlinico Universitario Agostino Gemelli IRCCSDec 2020
NCT04080284Trial of Maintenance With Niraparib- Uterine Serous CarcinomaP2completed22Northwell HealthDec 2019
NCT05162196The Efficacy and Safety of Radiotherapy Plus Niraparib and Toripalimab in Patients With Recurrent Small Cell Lung CancerP2unknown57Wuhan UniversityJun 2022
NCT03806049Trial Comparing Niraparib-bevacizumab-Dostarlimab and Niraparib-bevacizumab to Standard of Care in Recurrent Ovarian CancerP3withdrawn0Nordic Society of Gynaecological Oncology - Clinical Trials UnitDec 2019
NCT04926324A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal CancersP1/P2terminated3University of IowaJul 2022
NCT03307785Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042P1completed60Tesaro, Inc.Oct 2017
NCT04185831MEGALiTA MolEcularly Guided Anti-Cancer Drug Off-Label TrialP2active not recruiting167Uppsala University HospitalOct 2020
NCT03404960ParpvaxNiraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based ChemotherapyP1/P2completed104University of PennsylvaniaJan 2018
NCT05385068tA Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPiP2unknown35Peking Union Medical College HospitalJun 2022
NCT03891576NewtonNewton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)P2terminated83Mario Negri Institute for Pharmacological ResearchNov 2019
NCT05442749PARPi-PANCNiraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic CancerP2terminated2Centre Leon BerardOct 2022
NCT05169437PAVONiraparib in the Treatment of Patients With Advanced PALB2 Mutated TumorsP2terminated22Tempus AIMar 2022
NCT03598270ANITAPlatinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian CancerP3completed417Grupo Español de Investigación en Cáncer de OvarioNov 2018
NCT03425201NICARAGUANiraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA)P1/P2completed67Fundacion CRIS de Investigación para Vencer el CáncerOct 2019
NCT03326193A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based ChemotherapyP2completed105Tesaro, Inc.Dec 2017
NCT03891615Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung CancerP1unknown30Massachusetts General HospitalJun 2019
NCT04826198REVOCANSafety 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 MonthsP1/P2terminated13Gustave Roussy, Cancer Campus, Grand ParisOct 2020
NCT04734665NIRVANA-RNiraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP InhibitorP2unknown44Yonsei UniversityJul 2021
NCT05311579Niraparib Plus Anlotinib for Recurrent Ovarian CancerP2unknown36Lei LiMar 2022
NCT04288687A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair DefectsP2completed11Abramson Cancer Center at Penn MedicineOct 2020
NCT05297864OU-SCC-PI-4GPARP Inhibition for Gliomas (PI-4G or π4g)P2terminated15University of OklahomaJun 2022
NCT04267939BAY1895344ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian CancerP1terminated14BayerFeb 2020
NCT04240106LUZERNNiraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)P2completed14MedSIRJun 2020
NCT03654833MiSTMesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant MesotheliomaP2unknown186University of LeicesterJan 2019
NCT05162872Niraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal CarcinomaP2unknown99Sun Yat-sen UniversityAug 2021
NCT03209401Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor MalignanciesP1terminated23Georgetown UniversityOct 2017
NCT05666349RiNGReirradiation and Niraparib in Patients With Recurrent GlioblastomaP1withdrawn0University College, LondonOct 2023
NCT05261269A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast CancerP1completed30Dantari, Inc.Feb 2022
NCT04284852NEOPRIMANiraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant SettingP2completed20The University of Hong KongMay 2020
NCT04895046Maintenance Niraparib and Dostarlimab in Advanced CholangiocarcinomaP2withdrawn0Walid Shaib, MDOct 2021
NCT05412706BohèmeNiraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction TherapyP2withdrawn0Ospedale Policlinico San MartinoSep 2023
NCT04655183Study of M4344 in Combination With NiraparibP1/P2withdrawn0EMD Serono Research & Development Institute, Inc.Dec 2020
NCT03783949EUDARIOEuropean Trial on Enhanced DNA Repair Inhibition in Ovarian CancerP2completed122Universitaire Ziekenhuizen KU LeuvenNov 2018
NCT02854436GalahadAn Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair AnomaliesP2completed289Janssen Research & Development, LLCAug 2016
NCT03695380A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian CancerP1completed77Hoffmann-La RocheJan 2019
NCT03221400PEN-866 in Patients With Advanced Solid MalignanciesP1/P2unknown340Tarveda TherapeuticsAug 2017
NCT03329001Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib CapsuleP1completed236Tesaro, Inc.Dec 2017
NCT04885413An 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 PatientsP2unknown37Sun Yat-sen UniversityJul 2021
NCT03154281Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and BreastP1completed14Avera McKennan Hospital & University Health CenterJul 2017
NCT04235101Phase I Study of SYD985 With Niraparib in Patients With Solid TumorsP1completed32Byondis B.V.Jun 2020
NCT04764084HRRNiraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid TumorsP1unknown52Peking University Cancer Hospital & InstituteApr 2021
NCT04508803CHANGEABLECombination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast CancerP2completed37Fudan UniversitySep 2020
NCT03925350HREfficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) MutationP2unknown41California Pacific Medical Center Research InstituteMar 2019
NCT03840967A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric AdenocarcinomaP2terminated14Shadia Jalal, MDJul 2019
NCT05734911Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Studycompleted199Zhongda HospitalJan 2019
NCT04715620Niraparib Combined With Radiotherapy in rGBMP2unknown30Tianjin Huanhu HospitalJan 2021
NCT05130515CC-ANNIEAnlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.P2completed6Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityDec 2021
NCT03759587Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian CancerP2completed19TakedaDec 2018
NCT03759600Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian CancerP2completed20TakedaDec 2018
NCT03752216NiQoLeNIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.P4completed141ARCAGY/ GINECO GROUPApr 2019
NCT03076203Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad)P1completed14Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversitySep 2017
NCT06086665REFIRMThe Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancercompleted850Asan Medical CenterDec 2019
NCT04556071AVANIRA3Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian CancerP2unknown32Xiaoxiang ChenNov 2020
NCT04774406Arterial Hypertension Related to PARP Inhibitors (ArteRIB)completed2,336University Hospital, CaenFeb 2021
NCT03207347DDRA Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)P2completed37University of FloridaAug 2018
NCT04392102A Study of Niraparib in Patients With Relapsed Ovarian CancerP2completed15Zai Lab (Shanghai) Co., Ltd.Aug 2020
NCT04395612CQGOG0101Niraparib Combined With Brivanib or Toripalimab in Patients With Cervical CancerP2unknown38Chongqing University Cancer HospitalMay 2020
NCT02826512A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer PatientsP2terminated9The Netherlands Cancer InstituteMay 2018
NCT05401214Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)approved for marketing0Janssen Research & Development, LLC
NCT04217798Efficacy and Safety of Niraparib Combined With Oral Etoposide in Platinum Resistant/Refractory Recurrent Ovarian CancerP2unknown36Peking Union Medical College HospitalMay 2020
NCT05751629COHORT-AStudy to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian CancerP2completed41Tesaro, Inc.Nov 2018
NCT04376073ANNIEAnlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian CancerP2unknown40Jihong LiuMay 2020
NCT04178460A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior TreatmentP1terminated60Zai Lab (Shanghai) Co., Ltd.Feb 2020
NCT04409002Niraparib + Dostarlimab + RT in Pancreatic CancerP2completed18Massachusetts General HospitalJul 2020
NCT03955471MOONSTONEStudy to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian CancerP2terminated41Tesaro, Inc.Oct 2019
NCT01847274A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian CancerP3completed596Tesaro, Inc.Jun 2013
NCT02354131AVANOVANiraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian CancerP1/P2completed108Nordic Society of Gynaecological Oncology - Clinical Trials UnitFeb 2015
NCT01905592BRAVOA Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer PatientsP3terminated216Tesaro, Inc.Feb 2014
NCT02657889TOPACIONiraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian CancerP1/P2completed122Tesaro, Inc.Apr 2016
NCT03945084Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based ChemotherapyP2completed58University of Turin, ItalyAug 2019
NCT03308942PD-1Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer ParticipantsP2completed53Tesaro, Inc.Sep 2017
NCT02354586QUADRAA Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy RegimensP2completed463Tesaro, Inc.Mar 2015
NCT04546373Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancercompleted316Grupo Español de Investigación en Cáncer de OvarioSep 2020
NCT02044120ESP1/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 SarcomaP1completed34Sarcoma Alliance for Research through CollaborationMay 2014
NCT04785716Real-life Use of Niraparib in a Patient Access Program in Norwaycompleted106Kristina LindemannJul 2017
NCT03359850Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment PatientsP1completed17Tesaro, Inc.Feb 2018
NCT03895788A Study of Niraparib in Combination With Brivanib in Recurrent Ovarian CancerP1unknown24Hunan Cancer HospitalJan 2019
NCT03329937Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast CancerP1completed21Tesaro, Inc.Apr 2018
NCT03497429A Study of Niraparib as Single Agent in Participants With Advanced Solid TumorsP1completed9TakedaApr 2018
NCT02924766BEDIVEREA Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)P1completed34Janssen Research & Development, LLCOct 2016
NCT03551171The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian CancerP1completed42Zai Lab (Shanghai) Co., Ltd.Dec 2017
NCT02476552Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With CancerP1completed12Tesaro, Inc.Feb 2015
NCT03025867Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancerapproved for marketing0Tesaro, Inc.
NCT02500901CRPCEnzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)P1terminated2Paul Mathew, MDMar 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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