BENITIONSClinical Trial Intelligence

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
第1/2相
スポンサーNational Cancer Institute (NCI)
ステータス実施中(募集終了)
参加者数132 名
介入(薬剤)Biopsy Procedure, Biospecimen Collection, Computed Tomography, Laboratory Biomarker Analysis, Magnetic Resonance Imaging
開始日2019年2月4日
完了日2025年3月31日
結果公開日2026年5月5日

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 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

BENITIONS で見る ClinicalTrials.gov の原文を見る

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