A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer
Hoffmann-La Roche
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features * Progressive metastatic CRPC, defined as any of the following: PSA progression, defined by a minimum of two rising PSA values from three consecutive assessments with an interval of at least 7 days between assessments and with a minimal starting value of PSA \>=1 ng/mL; The most recent qualifying PSA value must be determined within 14 days of enrollment; Soft tissue disease progression, defined by Response Evaluation Criteria in Solid Tumors, Version 1.1…
Interventions
- DrugInavolisib
Inavolisib will be administered orally as per the schedule specified in the protocol.
- DrugEnzalutamide
Enzalutamide will be administered orally as per the schedule specified in the protocol.
- DrugAbiraterone
Abiraterone will be administered orally as per the schedule specified in the protocol.
- DrugDocetaxel
Docetaxel will be administered intravenously as per the schedule specified in the protocol.
Locations (20)
- UCSFSan Francisco, California
- Holden Comprehensive Cancer CenterIowa City, Iowa
- Montefiore Einstein Cancer CenterThe Bronx, New York
- Carolina Urologic Research CenterMyrtle Beach, South Carolina
- Sunshine Coast University HospitalBirtinya, Queensland
- Royal Brisbane & Womens HospitalHerston, Queensland