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

RecruitingPhase 3

Sponsor: Pfizer

Conditions: Metastatic Castration-Resistant Prostate Cancer

Interventions: PF-06821497, Placebo, Enzalutamide

Countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, China, Czechia

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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.
* 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.
* 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.

Locations (240)

Chandler, Arizona, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Glendale, Arizona, United States
Goodyear, Arizona, United States
Mesa, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Fayetteville, Arkansas, United States
Little Rock, Arkansas, United States
Rogers, Arkansas, United States
Springdale, Arkansas, United States
Anaheim, California, United States
Fountain Valley, California, United States
Glendale, California, United States
Glendale, California, United States
Laguna Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
Lisle, Illinois, United States
Lisle, Illinois, United States
Quincy, Illinois, United States
Quincy, Illinois, United States
Westmont, Illinois, United States
Omaha, Nebraska, United States
Santa Fe, New Mexico, United States
The Bronx, New York, United States
The Bronx, New York, United States
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