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Last Updated: November 5, 2024

CLINICAL TRIALS PROFILE FOR OLAPARIB


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505(b)(2) Clinical Trials for olaparib

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT04538378 ↗ Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors Recruiting National Cancer Institute (NCI) Phase 2 2021-07-07 Background: Lung cancers with EGFR mutations may develop resistance to therapies targeting this protein by evolving/being transformed into small cell or neuroendocrine cancers. There are no standard treatments for it. Researchers want to see if a new combination of drugs can help. Objective: To see if the combination of durvalumab and olaparib will cause tumors to shrink. Eligibility: Adults age 18 and older who had EGFR-mutated non-small-cell lung carcinoma (NSCLC) that was treated and now transformed to SCLC or another neuroendocrine tumor. Design: Participants will be screened under a separate protocol. They may have a tumor biopsy. Participants will have a physical exam. They will have a review of their symptoms, their medicines, and their ability to do their normal activities. They will have blood tests. They will have an electrocardiogram to evaluate their heart. Participants will have a computed tomography (CT) scan, a series of x-rays taken of parts of the body. Participants will get durvalumab on Day 1 of each 28-day cycle. It is given through a small plastic tube that is put in an arm vein. They will take olaparib by mouth twice every day. They will keep a medicine diary. Participants will take the study drugs until their disease gets worse or they have unacceptable side effects. About 30 days after they stop taking the study drugs, participants will have a follow-up visit. Then they will be contacted every 6 months for the rest of their life....
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for olaparib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00494234 ↗ Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Breast Cancer Active, not recruiting KuDOS Pharmaceuticals Limited Phase 2 2007-06-15 The purpose of the study is to see if the drug KU 0059436 (olaparib) is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists
NCT00494234 ↗ Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Breast Cancer Active, not recruiting AstraZeneca Phase 2 2007-06-15 The purpose of the study is to see if the drug KU 0059436 (olaparib) is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists
NCT00494442 ↗ Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer Completed KuDOS Pharmaceuticals Limited Phase 2 2007-06-11 The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.
NCT00494442 ↗ Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer Completed AstraZeneca Phase 2 2007-06-11 The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.
NCT00515866 ↗ Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer Completed AstraZeneca Phase 1 2007-08-01 The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer.
NCT00516373 ↗ A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP) Active, not recruiting AstraZeneca Phase 1 2005-07-04 To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients
NCT00516438 ↗ Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan Completed KuDOS Pharmaceuticals Limited Phase 1 2007-07-01 The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for olaparib

Condition Name

Condition Name for olaparib
Intervention Trials
Ovarian Cancer 41
Breast Cancer 37
Prostate Cancer 18
Triple Negative Breast Cancer 12
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Condition MeSH

Condition MeSH for olaparib
Intervention Trials
Ovarian Neoplasms 77
Breast Neoplasms 72
Carcinoma, Ovarian Epithelial 63
Neoplasms 58
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Clinical Trial Locations for olaparib

Trials by Country

Trials by Country for olaparib
Location Trials
Canada 166
France 139
Spain 116
United Kingdom 113
Japan 96
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Trials by US State

Trials by US State for olaparib
Location Trials
New York 78
California 77
Texas 68
Florida 64
Pennsylvania 61
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Clinical Trial Progress for olaparib

Clinical Trial Phase

Clinical Trial Phase for olaparib
Clinical Trial Phase Trials
Phase 4 6
Phase 3 33
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for olaparib
Clinical Trial Phase Trials
Recruiting 151
Active, not recruiting 82
Not yet recruiting 68
[disabled in preview] 74
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Clinical Trial Sponsors for olaparib

Sponsor Name

Sponsor Name for olaparib
Sponsor Trials
AstraZeneca 167
National Cancer Institute (NCI) 61
Merck Sharp & Dohme Corp. 38
[disabled in preview] 40
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Sponsor Type

Sponsor Type for olaparib
Sponsor Trials
Other 387
Industry 314
NIH 61
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