A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT07287150 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-05-06
Summary
This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.
Conditions
Interventions
- DRUG
-
Inavolisib
Inavolisib will be administered orally as per the schedule specified in the protocol.
- DRUG
-
Enzalutamide will be administered orally as per the schedule specified in the protocol.
- DRUG
-
Abiraterone
Abiraterone will be administered orally as per the schedule specified in the protocol.
- DRUG
-
Docetaxel will be administered intravenously as per the schedule specified in the protocol.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-11
- Primary Completion
- 2028-03-31
- Completion
- 2029-07-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Brazil
- Canada
- France
- South Korea
- Spain
Study Locations
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