A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)
A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)
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 physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment.
The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.
Inclusion Criteria:
Exclusion Criteria:
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, CDK4/6 inhibitors, or other systemic anti-cancer treatment, with the following exceptions:
Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
Inadequate organ function.
Aventura, Florida 33180, United States
Coral Gables, Florida 33146, United States
Deerfield Beach, Florida 33442, United States
Kendall, Florida 33176, United States
Miami, Florida 33136, United States
Miami, Florida 33136, United States
N. Venice, Florida 34275, United States
Plantation, Florida 33324, United States
Louisville, Kentucky 40202, United States
Lancaster, Pennsylvania 17604, United States
CABA, Buenos Aires C1120AAT, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ, Argentina
Capital, Córdoba Province X5008HHW, Argentina
Buenos Aires, C1431FWO, Argentina
Santo André, São Paulo 09060-650, Brazil
Wuhan, Hubei 430022, China
Nanjing, Jiangsu 210008, China
Lyon Cedex08, Auvergne-Rhône-Alpes 69373, France
Nîmes, GARD 30029, France
Clermont-Ferrand, 63011, France
Münster, North Rhine-Westphalia 48149, Germany
Chaïdári, Attikí 124 62, Greece
Budapest, Pest County 1122, Hungary
Meldola, Emilia-Romagna 47014, Italy
Shinjuku-ku, Tokyo 1608582, Japan
Grudziądz, Kuyavian-Pomeranian Voivodeship 86-300, Poland
Krakow, Lesser Poland Voivodeship 30-348, Poland
Krakow, Lesser Poland Voivodeship 31-826, Poland
Opole, Opole Voivodeship 45-061, Poland
Seoul, Seoul-teukbyeolsi [seoul] 03722, South Korea
Istanbul, İ̇stanbul 34722, Turkey (Türkiye)