Trials / Active Not Recruiting
Active Not RecruitingNCT04253262
A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer
A Phase Ib/II Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Brown University · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Rucaparib | Rucaparib (PO twice daily continuous) |
| DRUG | Copanlisib | Copanlisib (IV day 1, 8, 15; 28 day cycle) |
Timeline
- Start date
- 2020-04-03
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
- First posted
- 2020-02-05
- Last updated
- 2025-05-04
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04253262. Inclusion in this directory is not an endorsement.