Status:
RECRUITING
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Lead Sponsor:
Pfizer
Conditions:
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to ph...
Eligibility Criteria
Inclusion
- 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 surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
- Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
Exclusion
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant inappropriate for the study.
- Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
- Clinically significant cardiovascular disease.
- Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
- Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment, with the following exceptions:
- Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
- Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
- Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
- Inadequate organ function.
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06551324
Start Date
October 21 2024
End Date
October 29 2028
Last Update
January 9 2026
Active Locations (235)
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1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
2
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
3
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States, 85297
4
Ironwood Cancer & Research Centers
Glendale, Arizona, United States, 85306