Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis
Phase 1/2
Active, not recruiting
NCT03317392
| Condition | Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 |
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| Phase | Phase 1/2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 132 participants |
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| Interventions | Biopsy Procedure, Biospecimen Collection, Computed Tomography, Laboratory Biomarker Analysis, Magnetic Resonance Imaging |
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| Start date | Feb 4, 2019 |
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| Completion date | Mar 31, 2025 |
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| Results posted | May 5, 2026 |
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Summary
This phase I/II trial studies the best dose and side effects of olaparib and how well it works with radium Ra 223 dichloride in treating patients with castration-resistant prostate cancer that has spread to the bone and other places in the body (metastatic). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Radioactive drugs, such as radium Ra 223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Giving olaparib and radium Ra 223 dichloride may help treat patients with castration-resistant prostate cancer.
Phase I: Maximum Tolerated Dose
56 days · mg
| Phase I Radium223+Olaparib Dose Level 1 | 200 mg |
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| Phase I Radium223+Olaparib Dose Level 2 | 200 mg |
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Phase II: Radiographic Progression-free Survival (rPFS)
From randomization to date of radiographic progression or death due to any cause, whichever occurs first, or censored at the date of last disease assessment. Up to approximately 2 years · months
| Phase II Arm I (Radium Ra 223 Dichloride, Olaparib) | 8.9 months |
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| Phase II Arm II (Radium Ra 223 Dichloride) | 4.7 months |
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Open in BENITIONS
View on ClinicalTrials.gov
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