Status:
RECRUITING
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
Lead Sponsor:
Pfizer
Conditions:
Metastatic Castration-Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 abirat...
Detailed Description
This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCR...
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 medical or surgical castration.
- ECOG performance status 0 or 1, with a life expectancy of ≥12 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 make the participant inappropriate for the study.
- Known 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.
- Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.
- Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, 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 (ADT) agents;
- 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 (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
- Inadequate organ function.
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT06629779
Start Date
October 22 2024
End Date
November 30 2028
Last Update
March 4 2026
Active Locations (240)
Enter a location and click search to find clinical trials sorted by distance.
1
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
2
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States, 85297
3
Palo Verde Hematology Oncology
Glendale, Arizona, United States, 85304
4
Ironwood Cancer & Research Centers
Glendale, Arizona, United States, 85306