Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis
1/2期
进行中(已停止招募)
NCT03317392
| 适应症 | Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 |
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| 分期 | 1/2期 |
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| 申办方 | National Cancer Institute (NCI) |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 132 人 |
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| 干预(药物) | Biopsy Procedure, Biospecimen Collection, Computed Tomography, Laboratory Biomarker Analysis, Magnetic Resonance Imaging |
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| 开始日期 | 2019年2月4日 |
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| 完成日期 | 2025年3月31日 |
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| 结果公布日 | 2026年5月5日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。