BENITIONSClinical Trial Intelligence

Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer

Phase 2 Active, not recruiting NCT02893917

ConditionAdvanced Prostate Adenocarcinoma With Neuroendocrine Differentiation, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation, Metastatic Prostate Carcinoma
PhasePhase 2
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment90 participants
InterventionsCediranib, Olaparib
Start dateAug 11, 2017
Completion dateMar 14, 2023
Results postedMar 30, 2025

Summary

This randomized phase II trial studies how well olaparib with or without cediranib works in treating patients with castration-resistant prostate cancer that has spread to 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. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving olaparib and cediranib may help treat patients with castration-resistant prostate cancer.

Radiographic Progression Free Survival

Time interval from random assignment to the date when the first site of disease is found to progress, or death, whichever occurs first, assessed up to 5 years · months

Arm A (Olaparib, Cediranib)8.5 months
Arm B (Olaparib)4.0 months
p-value0.0359
Hazard Ratio (HR)0.617 (95% CI 0.392–0.969)

Open in BENITIONS View on ClinicalTrials.gov

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