Olaparib Clinical Trials

What Is Olaparib?

Olaparib, also known by the brand name Lynparza™, is an FDA-approved medication for advanced BRCA-mutated ovarian cancer. It is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. Olaparib works by stopping cancer cells from fixing damage to their DNA, particularly in cancers that have mutations in genes like BRCA1 or BRCA2, which are involved in DNA repair. This mechanism makes cancer cells more vulnerable and can lead to their death.

Beyond its approved use, olaparib is being extensively investigated in clinical trials for various other cancers and conditions. These studies aim to understand its safety and effectiveness when used alone or in combination with other treatments.

Uses and Conditions Under Study

Olaparib is currently being studied in 409 clinical trials with a total enrollment of 87,757 participants. These trials explore its potential across a wide range of conditions, primarily focusing on cancers with specific genetic characteristics.

• Ovarian and Fallopian Tube Cancers: Olaparib is extensively studied for ovarian cancer (48 trials), fallopian tube cancer (12 trials), and recurrent ovarian carcinoma (9 trials). Its role as a maintenance therapy, particularly in patients with BRCA1/2 mutations or homologous recombination deficiency (HRD), has shown promise in improving progression-free survival.
• Breast Cancer: There are 34 trials investigating olaparib for breast cancer, including specific subtypes like Anatomic Stage IV Breast Cancer AJCC v8 (9 trials) and Triple Negative Breast Cancer (9 trials). Studies are exploring its use in HR-positive, HER2-negative advanced or metastatic breast cancer, and in BRCA1/2 and PALB2 associated HER2-negative breast cancer.
• Prostate Cancer: Olaparib is being evaluated in 17 trials for prostate cancer and 10 trials for metastatic castration-resistant prostate cancer. Research focuses on its effectiveness in patients with DNA repair mutations or aggressive variant prostate cancer.
• Cancers with BRCA Mutations: Given its mechanism, olaparib is specifically studied in conditions involving BRCA1 Mutation (10 trials) and BRCA2 Mutation (9 trials), as these genetic alterations can make cancer cells more sensitive to PARP inhibition.
• Other Cancers: Olaparib is also being investigated for a variety of other solid tumors, including soft tissue sarcomas, relapsed/refractory solid tumors in pediatric patients, pancreatic acinar cell carcinoma, melanoma, neuroendocrine tumors, head and neck squamous cell carcinoma, recurrent glioblastoma, mesothelioma, and osteosarcoma. These studies often target cancers with mutations in the homologous recombination repair (HRR) pathway.
• Pulmonary Arterial Hypertension (PAH): In early-phase clinical trials, olaparib is being explored for its potential role in treating pulmonary arterial hypertension, a progressive lung condition, by targeting DNA damage and PARP activity.

Dosing

Olaparib is primarily administered orally in tablet form. Various strengths have been studied in clinical trials, including 100 mg, 150 mg, 200 mg, 250 mg, 300 mg, and 400 mg tablets. The standard adult dose often involves taking 600 mg per day, typically as two 300 mg tablets twice daily (BID).

In some studies, olaparib has been administered once daily (QD) or twice daily (BID), either alone or in combination with other therapies. For example, some trials involve subjects receiving 600 mg per day, given as two tablets BID. Investigational studies are also exploring olaparib in pediatric populations, with cohorts including patients aged 6 months to less than 6 years, 3 to less than 12 years, and 12 to less than 18 years, often in combination with other drugs like ceralasertib.

Side Effects

In clinical trials involving over 4,200 patients, the most common side effect reported with Olaparib was nausea. Approximately 40.0% of patients taking Olaparib experienced nausea, compared to 19.8% of those on placebo. Other frequently reported side effects included:

• Anemia: 36.5% of patients on Olaparib experienced anemia, compared to 11.6% on placebo.
• Fatigue: 25.1% of patients on Olaparib experienced fatigue, compared to 20.8% on placebo.
• Neutropenia (low white blood cell count): 23.9% of patients on Olaparib experienced neutropenia, compared to 12.9% on placebo.
• Alopecia (hair loss): 19.5% of patients on Olaparib experienced alopecia, compared to 14.8% on placebo.
• Diarrhea: 18.2% of patients on Olaparib experienced diarrhea, compared to 13.6% on placebo.
• Vomiting: 17.1% of patients on Olaparib experienced vomiting, compared to 9.2% on placebo.
• Decreased appetite: 15.9% of patients on Olaparib experienced decreased appetite, compared to 10.1% on placebo.

Some side effects were reported at similar or slightly lower rates in patients taking Olaparib compared to placebo, such as headache (11.6% on Olaparib vs 12.2% on placebo) and joint pain (arthralgia) (10.1% on Olaparib vs 12.5% on placebo).

Clinical Trial Results

BRCA-positive Advanced Breast Cancer

A study (NCT00494234) investigated Olaparib in patients with BRCA-positive advanced breast cancer. Patients received either 100 mg or 400 mg of Olaparib. The 400 mg dose showed a median tumor size reduction of 29.43%, compared to a 10.14% reduction with the 100 mg dose. The clinical benefit rate, meaning patients who experienced tumor shrinkage or stable disease for at least 24 weeks, was 84.6% for the 400 mg dose, versus 70.8% for the 100 mg dose. The objective response rate (ORR), indicating confirmed tumor shrinkage, was 42.3% with the 400 mg dose, compared to 25.0% with the 100 mg dose. Patients on the 400 mg dose also experienced longer progression-free survival (PFS) with a median of 193.5 days, compared to 122 days for the 100 mg dose. Serious adverse events occurred in 33.3% of patients on the 400 mg dose and 18.5% of patients on the 100 mg dose.

Colorectal Cancer

In a study (NCT00912743) of Olaparib in pretreated patients with measurable colorectal cancer, overall survival was a median of 290.5 days for patients with non-microsatellite instability-high (non-MSI-H) tumors and 248 days for those with MSI-H tumors. Progression-free survival was a median of 61 days for MSI-H patients and 55 days for non-MSI-H patients. No patients in either group achieved a tumor response.

Gastric Cancer

A study (NCT01063517) compared Olaparib plus paclitaxel to placebo plus paclitaxel in gastric cancer patients. In the overall study population, patients receiving Olaparib plus paclitaxel had a median overall survival of 13.1 months, compared to 8.3 months for those receiving placebo plus paclitaxel. The objective response rate in the overall study population was 22.6% (14 out of 62 participants) for the Olaparib combination, compared to 14.8% (9 out of 61 participants) for the placebo combination. For patients with ATM-negative tumors, progression-free survival was a median of 5.29 months with Olaparib plus paclitaxel, versus 3.68 months with placebo plus paclitaxel. Nine ATM-negative patients on the Olaparib combination and six on the placebo combination achieved an objective response.

BRCA1 or BRCA2 Mutation Cancers

An open-label study (NCT01078662) assessed Olaparib in patients with confirmed BRCA1 or BRCA2 mutations across various cancer types. The objective response rate for all patients was 29.3%. Response rates varied by cancer type: 57.1% for prostate cancer, 35.9% for ovarian cancer, 21.7% for pancreatic cancer, and 13.8% for breast cancer. The median duration of response for all patients was 208 days, with prostate cancer patients showing the longest duration at 326.5 days. Median overall survival was 18.38 months for prostate cancer patients and 16.62 months for ovarian cancer patients. Progression-free survival was a median of 7.15 months for prostate cancer and 7.03 months for ovarian cancer.

Advanced Ovarian Cancer

A study (NCT01081951) in advanced ovarian cancer compared Olaparib combined with carboplatin and paclitaxel to carboplatin and paclitaxel alone. Patients receiving the Olaparib combination had a median progression-free survival of 12.2 months, compared to 9.6 months for those on chemotherapy alone. However, the number of deaths was higher in the Olaparib combination arm (54 out of 162 patients, or 33.3%) compared to the chemotherapy-alone arm (47 out of 163 patients, or 28.8%). The percentage change in tumor size was similar between both groups, with a 38.4% reduction for the Olaparib combination and a 39.1% reduction for chemotherapy alone.

Currently Recruiting Trials

Olaparib is currently being investigated in numerous clinical trials to explore its potential as a treatment for various cancers, often in combination with other therapies. These studies aim to understand the safety, effectiveness, and optimal dosages of Olaparib for patients.

• A Phase 1 bioequivalence study, NCT07371104, is comparing different formulations of Olaparib (DWZ2501 and DWC202510) in 40 patients with advanced BRCA-mutated high-grade ovarian cancer. This open-label, randomized, multi-dose crossover study is sponsored by Daewoong Pharmaceutical Co. LTD.
• The M.D. Anderson Cancer Center is sponsoring a Phase 1b trial, NCT07382544, combining BMS-986504 with Olaparib in 36 patients with advanced solid tumors that have MTAP loss. The study will evaluate the safety and effects of this combination.
• The University of Colorado, Denver is conducting a Phase 1 study, NCT06856499, to assess the safety and tolerability of Cirtuvivint in combination with Olaparib for 50 patients with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer.
• A Phase 1 study, NCT07156253, sponsored by Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd, is evaluating SYN818 with Olaparib in 110 adult patients with locally advanced or metastatic solid tumors, including ovarian and breast cancer with BRCA 1/2 and/or HRD.
• AbbVie is sponsoring a Phase 2 study, NCT07024784, of IMGN151 as monotherapy or in combination with other therapies, including Olaparib, in 377 adult participants with gynecologic cancers, specifically platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer.
• A Phase 3 trial, NCT06580314, sponsored by NRG Oncology, is comparing Olaparib for one year versus two years, with or without bevacizumab, in 880 patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer.
• The University of Alabama at Birmingham is running a Phase 2 trial, NCT05952453, for 20 patients with newly diagnosed stage III/IV ovarian cancer, evaluating neoadjuvant carboplatin/paclitaxel/pembrolizumab followed by maintenance Olaparib/pembrolizumab post-surgery.
• A Phase 2 study, NCT06686030, sponsored by Akeso, is exploring combination therapy of AK112 with chemotherapy and/or Olaparib in 150 patients with platinum-sensitive ovarian cancer.
• Pathos AI, Inc. is sponsoring a Phase 1/Phase 2 dose-finding study, NCT06785636, of Pocenbrodib alone and in combination with Olaparib or other agents in 252 patients with metastatic castration-resistant prostate cancer.
• GBG Forschungs GmbH is conducting a Phase 2 study, NCT06201234, evaluating the addition of elacestrant to Olaparib in 176 patients with advanced/metastatic HR+/HER2- breast cancer with gBRCA1/2 mutation.
• A Phase 1 study, NCT06686745, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd., is evaluating SIM0508 alone and in combination with Olaparib in 130 patients with advanced solid tumors.
• The University of Cologne is sponsoring a Phase 2 study, NCT06419179, of maintenance durvalumab and Olaparib after standard first-line treatment in 29 patients with HRD positive extensive disease small-cell lung cancer.
• The Australasian Gastro-Intestinal Trials Group is conducting a Phase 2 study, NCT06441747, investigating the combination of durvalumab and Olaparib in 40 patients with advanced cholangiocarcinoma after initial chemotherapy and durvalumab.
• Fundación de investigación HM is sponsoring a Phase 1/Phase 2 study, NCT06607692, combining 177Lu-DOTATATE (Lutathera®) with Olaparib for 25 children and adolescents with recurrent or relapsed solid tumors expressing somatostatin receptor.
• Eisbach Bio GmbH is investigating EIS-12656 as a single agent and in combination with Olaparib in a Phase 1/Phase 2 trial, NCT06525298, for 144 patients with specified advanced solid tumors, including those with homologous recombination deficiency.
• Dana-Farber Cancer Institute is sponsoring a Phase 1b study, NCT06488378, of axatilimab in combination with Olaparib in 20 patients with BRCA1/2 and PALB2-associated metastatic HER2-negative breast cancer.
• A Phase 2 study, NCT05485766, sponsored by Okayama University, is evaluating Olaparib plus pembrolizumab following platinum-based chemotherapy plus pembrolizumab as neoadjuvant therapy for 23 patients with germline BRCA 1/2 mutated triple-negative breast cancer.
• Mary D Chamberlin is sponsoring a Phase 1 study, NCT05900895, to determine the safety and recommended Phase 2 dose of Olaparib in combination with 17b-estradiol in 6 post-menopausal patients with advanced ER+/HER2- breast cancer.
• The National Cancer Centre, Singapore, is conducting a Phase 2 trial, NCT06160843, to evaluate the efficacy and safety of pembrolizumab in combination with Olaparib in 24 participants with relapsed/refractory Peripheral T-cell Lymphoma.
• Gustave Roussy, Cancer Campus, Grand Paris, is sponsoring a randomized Phase 3 trial, NCT06712472, testing maintenance Olaparib versus observation after adjuvant chemoradiation for 554 patients with p53abn endometrial cancer.
• Merck Sharp & Dohme LLC is sponsoring a Phase 1/Phase 2 substudy, NCT06353386, evaluating the safety and efficacy of opevesostat-based treatment combinations, including Olaparib + Opevesostat, in 220 participants with metastatic castration-resistant prostate cancer.
• A Phase 1/Phase 2 study, NCT06217757, sponsored by Sichuan University, is evaluating the safety and efficacy of low-dose radiotherapy combined with sugemalimab, Olaparib, etoposide, and cisplatin for 45 patients with SLFN-11 positive extensive stage small cell lung cancer.
• Exelixis is sponsoring a Phase 1 study, NCT05932862, to investigate XL309 (ISM3091) alone and in combination with Olaparib in 429 participants with advanced solid tumors.
• Varun Monga, MBBS, is sponsoring a Phase 1/Phase 1b clinical trial, NCT06177171, evaluating the combination of Olaparib with ASTX727 in 18 patients with BRCA1/2- and homologous recombination deficient (HRD)-mutated tumors.
• The University of Colorado, Denver, is sponsoring a Phase 2 study, NCT05887609, evaluating the combination of mirvetuximab soravtansine and Olaparib as maintenance therapy in 53 patients with platinum-sensitive recurrent ovarian, peritoneal, or fallopian tube cancer.
• A Phase 2 study, NCT06078787, sponsored by Azienda Ospedaliero-Universitaria di Modena, is evaluating Olaparib monotherapy in 16 participants with advanced PALB2-related pancreatic cancer that has progressed after at least one prior treatment.
• Zin W Myint is sponsoring a Phase 2 trial, NCT05568550, evaluating pembrolizumab with radiation, with or without Olaparib, in 64 men with high-risk localized prostate cancer.
• Artios Pharma Ltd is sponsoring a Phase 1/Phase 2 study, NCT05898399, to evaluate ART6043 as monotherapy or in combination with Olaparib in 181 patients with advanced/metastatic solid tumors.
• The German Cancer Research Center is sponsoring a Phase 2 study, NCT05332561, evaluating genomics-guided targeted post-neoadjuvant therapy, including Olaparib, in 240 patients with early breast cancer.
• A Phase 2 ComboMATCH treatment trial, NCT05554328, sponsored by the National Cancer Institute (NCI), is comparing selumetinib plus Olaparib to selumetinib alone in 165 women with recurrent or persistent ovarian and endometrial cancers with RAS pathway mutations.
• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS is sponsoring a Phase 2 trial, NCT05623319, evaluating pembrolizumab and Olaparib in 60 patients with untreated extensive-stage small-cell lung cancer.
• Rana McKay, MD, is sponsoring a Phase 2 study, NCT05498272, evaluating neoadjuvant Olaparib + LHRH agonist prior to radical prostatectomy in 32 men with unfavorable intermediate-risk or high-risk localized prostate cancer with select HRR gene alterations.
• Santa Chiara Hospital is conducting an observational study, NCT06783127, to define clinical outcomes and predictive factors for 3000 mCRPC patients treated with Olaparib in clinical practice.
• Seoul National University Hospital is sponsoring a Phase 2 study, NCT05536128, evaluating the efficacy and safety of fulvestrant plus DNA damage repair inhibitors, including Olaparib, in 64 patients with hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor.
• L. Nicolas Gonzalez Castro, MD, PhD, is sponsoring a Phase 2 trial, NCT05463848, of surgical pembrolizumab +/- Olaparib with temozolomide for 78 patients with recurrent glioblastoma.
• H. Lee Moffitt Cancer Center and Research Institute is sponsoring a Phase 2 trial, NCT05524935, of Olaparib in combination with pembrolizumab for 37 patients with advanced uveal melanoma.
• The National Cancer Institute (NCI) is sponsoring a Phase 1/Phase 2 study, NCT04086485, of Lu-177-DOTATATE (Lutathera) in combination with Olaparib in 56 patients with inoperable gastroenteropancreatic neuroendocrine tumors.
• Incyte Corporation is sponsoring a Phase 1 study, NCT05238922, of INCB123667 as monotherapy and in combination with anticancer therapies, including Olaparib, in 604 subjects with advanced solid tumors.
• Erasmus Medical Center is sponsoring a Phase 1 dose-escalation study, NCT05870423, to determine the maximum tolerated dose of Olaparib in combination with PRRT in 24 patients with well-differentiated advanced gastroenteropancreatic NET progressive after PRRT.
• AGO Research GmbH is sponsoring a Phase 2 "Window of Opportunity" trial, NCT04644289, of Olaparib and durvalumab in 60 patients with histologically proven epithelial ovarian cancer.
• Asan Medical Center is sponsoring a Phase 2 study, NCT05222971, of Olaparib with or without durvalumab for 62 patients with DDR gene mutated biliary tract cancer following platinum-based chemotherapy.
• Colette Shen is sponsoring a Phase 1/Phase 2 study, NCT04711824, of stereotactic radiosurgery with Olaparib followed by durvalumab and physician's choice systemic therapy in 41 subjects with breast cancer brain metastases.
• The National Cancer Institute, Naples, is sponsoring a randomized, open-label, Phase 3 trial, NCT05255471, comparing Olaparib beyond progression to platinum chemotherapy after secondary cytoreductive surgery in 200 recurrent ovarian cancer patients.
• Memorial Sloan Kettering Cancer Center is sponsoring a Phase 2 study, NCT05188508, of pembrolizumab, Olaparib, and temozolomide for 57 people with glioma.
• Radboud University Medical Center is sponsoring a Phase 4 pharmacokinetic boosting study, NCT05078671, of Olaparib to improve exposure, tolerance, and cost-effectiveness in 160 cancer patients.
• Leiden University Medical Center is sponsoring a Phase 2/Phase 3 umbrella program, NCT05255653, refining adjuvant treatment in 1615 endometrial cancer patients based on molecular features, including a p53abn-RED trial with Olaparib.
• Yonsei University is sponsoring a Phase 1/Phase 2 study, NCT04592211, of Olaparib, pembrolizumab, and paclitaxel for 71 patients with recurrent/advanced gastric and gastro-esophageal junction cancer.
• The National Cancer Institute (NCI) is sponsoring a Phase 1 trial, NCT04633239, testing the addition of abemaciclib to Olaparib for 42 women with recurrent platinum-resistant ovarian cancer.
• The National Cancer Institute (NCI) is sponsoring a randomized Phase 2 double-blind study, NCT04858334, of Olaparib versus placebo following curative intent therapy in 152 patients with resected pancreatic cancer and a pathogenic BRCA1, BRCA2, or PALB2 mutation.
• The National Cancer Institute (NCI) is sponsoring a Phase 1 trial, NCT04585958, testing the combination of DS-8201a and Olaparib in 55 patients with HER2-expressing cancers, with expansion in platinum-resistant ovarian cancer.
• Memorial Sloan Kettering Cancer Center is sponsoring a Phase 2 study, NCT04683679, of radiation therapy with pembrolizumab and Olaparib or other radiosensitizers in 34 women with triple-negative or hormone-receptor positive/HER2-negative breast cancer.
• The University of Leeds is sponsoring a Phase 1 platform study, NCT04550104, of novel agents in combination with radiotherapy in 200 patients with non-small cell lung cancer, including an arm with Olaparib + radiotherapy.
• The University of Chicago is sponsoring a Phase 2 study, NCT04515836, of Olaparib in 56 patients with HRD malignant mesothelioma.
• Yonsei University is sponsoring a Phase 2 study, NCT04361370, of Olaparib maintenance with pembrolizumab and bevacizumab in 44 BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer.
• The M.D. Anderson Cancer Center is sponsoring a Phase 2 trial, NCT04090567, of Olaparib with cediranib or AZD6738 for the treatment of advanced or metastatic germline BRCA mutated breast cancer in 60 patients.
• University Health Network, Toronto, is sponsoring a Phase 2 study, NCT03991832, of Olaparib and durvalumab in 58 patients with IDH-mutated solid tumors, including glioma and cholangiocarcinoma.
• The VA Office of Research and Development is sponsoring a Phase 2 randomized clinical study, NCT04038502, comparing carboplatin or Olaparib for 100 patients with BRCA deficient metastatic castrate resistant prostate cancer.
• OHSU Knight Cancer Institute is sponsoring an Early Phase 1 trial, NCT04005690, of targeted pathway inhibition, including Olaparib, in 90 patients with pancreatic cancer.
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is sponsoring a Phase 2 study, NCT03786796, of Olaparib in 20 metastatic renal cell carcinoma patients with DNA repair gene mutations.
• National University Hospital, Singapore, is sponsoring a Phase 1 dose-escalation study, NCT03772561, of AZD5363 + Olaparib + Durvalumab in 40 patients with advanced or metastatic solid tumor malignancies.
• Merck Sharp & Dohme LLC is sponsoring a long-term safety and efficacy extension study, NCT03486873, for 3500 participants with advanced tumors who are currently on treatment or in follow-up in a pembrolizumab (MK-3475) study, with some arms including Olaparib.
• The Canadian Cancer Trials Group is sponsoring a Phase 2 "Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)", NCT03297606, for 720 patients with lymphoma, non-Hodgkin, multiple myeloma, and advanced solid tumors, which includes Olaparib as a potential targeted therapy.
• Merck Sharp & Dohme LLC is sponsoring a Phase 1/Phase 2 study, NCT02861573, of pembrolizumab combination therapies, including pembrolizumab + Olaparib, in 1200 participants with metastatic castration-resistant prostate cancer.
• The Netherlands Cancer Institute is sponsoring "The Drug Rediscovery Protocol (DRUP Trial)", NCT02925234, a Phase 2 study for 1550 patients with advanced cancer, where Olaparib is one of the commercially available targeted anticancer drugs prescribed based on genomic or protein expression variants.
• Gustave Roussy, Cancer Campus, Grand Paris, is sponsoring a Phase 1/Phase 2 European Proof-of-Concept Therapeutic Stratification Trial, NCT02813135, for 472 pediatric cancer patients with relapsed or refractory tumors, including an arm with Olaparib + Irinotecan.
• Cambridge University Hospitals NHS Foundation Trust is sponsoring a Phase 2/Phase 3 neoadjuvant trial, NCT03150576, investigating concurrent platinum-based chemotherapy with Olaparib in 780 patients with triple-negative breast cancer and/or germline BRCA positive breast cancer.
• The American Society of Clinical Oncology is sponsoring the "TAPUR" Phase 2 study, NCT02693535, testing FDA-approved drugs, including Olaparib, that target specific abnormalities in tumor genes in 4200 people with advanced stage cancer.
• Centre Leon Berard is sponsoring a Phase 2 study, NCT02029001, "MyOwnSpecificTreatment," for 900 patients with progressive solid tumors, with an arm for maintenance treatment including targeted therapies like Olaparib.
• QuantumLeap Healthcare Collaborative is sponsoring the "I-SPY TRIAL", NCT01042379, a Phase 2 study for 5000 patients with breast cancer, which includes an arm for durvalumab plus Olaparib.

Where to Participate

Clinical trials involving Olaparib are widely available across the United States, with studies being conducted at 1436 sites in 707 cities across 51 states. This broad reach aims to make participation accessible to a diverse patient population.

Some of the top cities with active Olaparib trials include:

• Las Vegas, Nevada (36 sites)
• Honolulu, Hawaii (31 sites)
• New York, New York (30 sites)
• Houston, Texas (26 sites)
• Chicago, Illinois (24 sites)
• Philadelphia, Pennsylvania (22 sites)
• Portland, Oregon (21 sites)
• St Louis, Missouri (20 sites)
• Seattle, Washington (19 sites)
• Columbus, Ohio (19 sites)

Eligibility for these trials generally includes individuals aged 3 to 120 years, of all genders. Healthy volunteers are typically not recruited for these studies, as they focus on patients with specific cancer diagnoses, and children are eligible for participation in some trials.

Development Timeline

The journey of Olaparib began with its first clinical trial on June 29, 2007, marking the start of extensive research into its therapeutic potential. Initially, the drug's development explored conditions such as IBS-C and hyperphosphatemia, but its focus quickly shifted and expanded to a wide range of cancers.

Over the years, the pipeline for Olaparib grew significantly, with a strong emphasis on cancers associated with DNA repair deficiencies, particularly those with BRCA mutations. Key conditions that became central to its development include ovarian cancer, breast cancer, prostate cancer, and metastatic castration-resistant prostate cancer. The drug's mechanism as a PARP inhibitor proved promising in these areas, leading to numerous studies.

Development has progressed through various phases, with Phase 2 trials being the most prevalent, accounting for 206 studies. There have also been 88 Phase 1 trials, 41 Phase 3 trials, and 40 Phase 1/Phase 2 trials, demonstrating a comprehensive approach to evaluating Olaparib's safety and efficacy. The latest trial is projected to conclude on March 20, 2026, indicating ongoing research and commitment to its potential.

AstraZeneca has been a primary driver of Olaparib's development, sponsoring 61 trials, while the National Cancer Institute (NCI) has also played a significant role, sponsoring 44 studies. In total, 409 trials have been conducted or are ongoing, enrolling a remarkable 87,757 participants, highlighting the extensive effort invested in understanding and utilizing Olaparib in cancer treatment.