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Last Updated: November 26, 2022

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Olaparib

Condition Name

Condition Name for Olaparib
Intervention Trials
Ovarian Cancer 38
Breast Cancer 33
Prostate Cancer 17
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Condition MeSH

Condition MeSH for Olaparib
Intervention Trials
Ovarian Neoplasms 73
Breast Neoplasms 66
Carcinoma, Ovarian Epithelial 58
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Clinical Trial Locations for Olaparib

Trials by Country

Trials by Country for Olaparib
Location Trials
Canada 159
France 136
Spain 114
United Kingdom 112
Japan 94
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Trials by US State

Trials by US State for Olaparib
Location Trials
New York 76
California 75
Texas 64
Florida 61
Pennsylvania 59
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Clinical Trial Progress for Olaparib

Clinical Trial Phase

Clinical Trial Phase for Olaparib
Clinical Trial Phase Trials
Phase 4 4
Phase 3 31
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Olaparib
Clinical Trial Phase Trials
Recruiting 139
Active, not recruiting 82
Not yet recruiting 55
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Clinical Trial Sponsors for Olaparib

Sponsor Name

Sponsor Name for Olaparib
Sponsor Trials
AstraZeneca 163
National Cancer Institute (NCI) 58
Merck Sharp & Dohme Corp. 38
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Sponsor Type

Sponsor Type for Olaparib
Sponsor Trials
Other 366
Industry 298
NIH 58
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