BENITIONSClinical Trial Intelligence

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

Фаза 1/2 Идёт, набор закрыт NCT03317392

ЗаболеваниеCastration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
ФазаФаза 1/2
СпонсорNational Cancer Institute (NCI)
СтатусИдёт, набор закрыт
Участники132 участн.
ВмешательствоBiopsy Procedure, Biospecimen Collection, Computed Tomography, Laboratory Biomarker Analysis, Magnetic Resonance Imaging
Дата начала4.02.2019
Дата завершения31.03.2025
Публикация результатов5.05.2026

Кратко

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

Открыть в BENITIONS Открыть на ClinicalTrials.gov

Другие исследования по этому заболеванию

Все исследования

Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.