BENITIONSClinical Trial Intelligence

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
分期1/2期
申办方National Cancer Institute (NCI)
状态进行中(已停止招募)
受试者人数132 人
干预(药物)Biopsy Procedure, Biospecimen Collection, Computed Tomography, Laboratory Biomarker Analysis, Magnetic Resonance Imaging
开始日期2019年2月4日
完成日期2025年3月31日
结果公布日2026年5月5日

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 1200 mg
Phase I Radium223+Olaparib Dose Level 2200 mg

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
Phase II Arm II (Radium Ra 223 Dichloride)4.7 months

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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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。