RecruitingMetastatic Castration-Resistant Prostate Cancer

A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

Eligible age

18+ yrs

Accepts

Men

Locations

10 states

Healthy volunteers

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About this study

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.

Sponsor: Pfizer

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.
✕ 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:
✕ 1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
✕ 2. 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.