A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Registration Number
- NCT04253262
- Lead Sponsor
- Brown University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Level -1 Copanlisib 400 mg Rucaparib, 45 mg (day 1 \& 15) Copanlisib Dose Level -2 Rucaparib 300 mg Rucaparib, 45 mg (day 1 \& 15) Copanlisib Dose Level -1 Rucaparib 400 mg Rucaparib, 45 mg (day 1 \& 15) Copanlisib Dose Level -2 Copanlisib 300 mg Rucaparib, 45 mg (day 1 \& 15) Copanlisib Dose Level 1 Rucaparib 400 mg Rucaparib, 45 mg Copanlisib Dose Level 1 Copanlisib 400 mg Rucaparib, 45 mg Copanlisib Dose Level 2 Rucaparib 500 mg Rucaparib, 45 mg Copanlisib Dose Level 2 Copanlisib 500 mg Rucaparib, 45 mg Copanlisib Dose Level 3 Rucaparib 600 mg Rucaparib, 45 mg Copanlisib Dose Level 3 Copanlisib 600 mg Rucaparib, 45 mg Copanlisib Dose Level 4 Rucaparib 600 mg Rucaparib, 60 mg Copanlisib Dose Level 4 Copanlisib 600 mg Rucaparib, 60 mg Copanlisib
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose Cycle 1 (each cycle is 28 days) through pre-dosing cycle 2, approximately 1 month. To evaluate the maximum tolerated dose of copanlisib with rucaparib in patients with metastatic castration-resistant prostate cancer.
Response Every 28 days on treatment, then every 3 months until progression of disease up to 3 years. To estimate the overall response rate of the combination of copanlisib and rucaparib in patients with metastatic castration-resistant prostate cancer.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Helen Diller Family Comprehensive Cancer Center University of California San Francisco
🇺🇸San Francisco, California, United States
Lifespan Cancer Institute
🇺🇸Providence, Rhode Island, United States