Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis
第1/2相
実施中(募集終了)
NCT03317392
| 対象疾患 | Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 |
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| 相 | 第1/2相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 132 名 |
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| 介入(薬剤) | Biopsy Procedure, Biospecimen Collection, Computed Tomography, Laboratory Biomarker Analysis, Magnetic Resonance Imaging |
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| 開始日 | 2019年2月4日 |
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| 完了日 | 2025年3月31日 |
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| 結果公開日 | 2026年5月5日 |
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概要
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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