CLINICAL TRIALS PROFILE FOR OLAPARIB
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505(b)(2) Clinical Trials for olaparib
Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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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 | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for olaparib
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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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 | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for olaparib
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