drugset / Trial / NCT04253262
A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer
Phase 1/2
Active not recruiting
13 enrolled
Brown University
Bayer · collabClovis Oncology, Inc. · collabRhode Island Hospital · collabThe Miriam Hospital · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2020-04-03
- Primary completion
- 2027-01
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Copanlisib | Small molecule | 45 mg | Intravenous |
| Subject | Copanlisib | Small molecule | 60 mg | Intravenous |
| Subject | Rucaparib | Small molecule | 300 mg | Oral |
| Subject | Rucaparib | Small molecule | 400 mg | Oral |
| Subject | Rucaparib | Small molecule | 500 mg | Oral |
| Subject | Rucaparib | Small molecule | 600 mg | Oral |