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

NCT04253262 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-05-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rucaparib

Rucaparib (PO twice daily continuous)

DRUG

Copanlisib

Copanlisib (IV day 1, 8, 15; 28 day cycle)

Sponsors & Collaborators

  • Rhode Island Hospital

    collaborator OTHER

  • The Miriam Hospital

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Clovis Oncology, Inc.

    collaborator INDUSTRY

  • Brown University

    lead OTHER

Principal Investigators

  • Benedito Carneiro, MD, MS · Brown University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-03
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253262 on ClinicalTrials.gov