A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-r
This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.
| Condition(s) | Metastatic Castration-Resistant Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve. |
| Who can participate | Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan. * Progressive disease in the setting of medical or surgical castration. * ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator. Exclusion Criteria: * Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study. * Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery. * |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Pfizer |
| Locations | Chandler, Arizona, United States; Gilbert, Arizona, United States; Glendale, Arizona, United States; Glendale, Arizona, United States; Goodyear, Arizona, United States; Mesa, Arizona, United States (+234 more sites) |
| Start date | 2024-10-22 |
| NCT ID | NCT06629779 |
| Official listing | https://clinicaltrials.gov/study/NCT06629779 |