BENITIONSClinical Trial Intelligence

Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis

1/2상 진행 중(모집 완료) NCT03317392

대상 질환Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
임상 단계1/2상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수132 명
중재(약물)Biopsy Procedure, Biospecimen Collection, Computed Tomography, Laboratory Biomarker Analysis, Magnetic Resonance Imaging
시작일2019년 2월 4일
완료일2025년 3월 31일
결과 공개일2026년 5월 5일

요약

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

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