Copanlisib + Rucaparib for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byBenedito Carneiro, MD, MS

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Brown University

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with metastatic castration-resistant prostate cancer who've progressed after certain treatments can join. They need a life expectancy of at least 3 months, acceptable organ function, and no recent serious cardiovascular events or other cancers in the last 5 years. Men must use contraception during and post-treatment for 6 months.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My cancer has worsened despite treatment with abiraterone, enzalutamide, or apalutamide.

My organs and bone marrow are functioning well.

+21 more

Exclusion Criteria

I am on immunosuppressive therapy but take 10mg/day or less of prednisone.

I have had cancer within the last 5 years.

I haven't had radiotherapy or chemo/immunotherapy in the last 2 weeks.

+24 more

Participant Groups

The trial is testing a combination of two drugs: Copanlisib and Rucaparib. It's an open-label study where all participants receive the same treatment to assess safety, how the body processes the drugs, and their effectiveness against prostate cancer.

6Treatment groups

Experimental Treatment

Group I: Dose Level 4Experimental Treatment2 Interventions

600 mg Rucaparib, 60 mg Copanlisib

Group II: Dose Level 3Experimental Treatment2 Interventions

600 mg Rucaparib, 45 mg Copanlisib

Group III: Dose Level 2Experimental Treatment2 Interventions

500 mg Rucaparib, 45 mg Copanlisib

Group IV: Dose Level 1Experimental Treatment2 Interventions

400 mg Rucaparib, 45 mg Copanlisib

Group V: Dose Level -2Experimental Treatment2 Interventions

300 mg Rucaparib, 45 mg (day 1 \& 15) Copanlisib