Clinical Trial

A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer

Active, Not Recruiting Phase 1/2
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Summary
This is a single arm Phase Ib/II, open label, safety, pharmacokinetic and efficacy clinical study in adult patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with the combination of copanlisib and rucaparib for as long as the patient does not have clinically significant progressive disease and/or unacceptable toxicity and/or as long as the investigator deems that the patient is benefiting from treatment. Treatment may also be stopped if the patient withdraws consent, or study termination occurs.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2020-01-31; most recent amendment 2025-05-02.
Status change: Recruiting → Active, Not Recruiting 2022-11-22
Status change: Not Yet Recruiting → Recruiting 2020-04-09
Trial Details
NCT Number NCT04253262
Lead Sponsor Brown University
Collaborators: Rhode Island Hospital, The Miriam Hospital, Bayer, Clovis Oncology, Inc.
Conditions Metastatic Castration-resistant Prostate Cancer
Enrollment 13 participants
Start Date 2020-04-03
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-04