A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
Recruiting · NCT06629779 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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:
- Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
- 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.
Where it is running
60 locations listed across 10 US states.
- Ironwood Cancer & Research Centers - Chandler, Arizona, United States
- Ironwood Cancer & Research Centers - Gilbert, Arizona, United States
- Palo Verde Hematology Oncology - Glendale, Arizona, United States
- Ironwood Cancer & Research Centers - Glendale, Arizona, United States
- Ironwood Cancer & Research Centers - Goodyear, Arizona, United States
- Ironwood Cancer & Research Centers - Mesa, Arizona, United States
- Ironwood Cancer & Research Centers - Mesa, Arizona, United States
- Ironwood Cancer & Research Centers - Phoenix, Arizona, United States
- Ironwood Cancer & Research Centers - Scottsdale, Arizona, United States
- Highlands Oncology - Fayetteville, Arkansas, United States
- Arkansas Urology - Little Rock - Little Rock, Arkansas, United States
- Highlands Oncology - Rogers, Arkansas, United States
- Highlands Oncology Group - Springdale, Arkansas, United States
- Los Angeles Cancer Network (LACN) - Anaheim, California, United States
- Los Angeles Cancer Network (LACN) - Fountain Valley, California, United States
- Los Angeles Cancer Network (LACN) - Glendale, California, United States
- Los Angeles Cancer Network (LACN) - Glendale, California, United States
- Los Angeles Cancer Network (LACN) - Laguna Hills, California, United States
- Los Angeles Cancer Network (LACN) - Los Angeles, California, United States
- Los Angeles Cancer Network (LACN) - Los Angeles, California, United States
- Medical Oncology Associates of San Diego - San Diego, California, United States
- Accellacare of Duly - Lisle, Illinois, United States
- Duly Health and Care (Bone Scintigraphy) - Lisle, Illinois, United States
- Blessing Hospital - Quincy, Illinois, United States
- Blessing Physician Services - Quincy, Illinois, United States
- Duly Health and Care (CT and MRI) - Westmont, Illinois, United States
- Adult & Pediatric Urology, PC - Omaha, Nebraska, United States
- CHRISTUS St. Vincent Regional Cancer Center - Santa Fe, New Mexico, United States
- Montefiore Medical Center - Medical Park - The Bronx, New York, United States
- Montefiore Medical Center - The Bronx, New York, United States
- AUC Urologists, LLC - Myrtle Beach, South Carolina, United States
- Carolina Urologic Research Center, LLC - Myrtle Beach, South Carolina, United States
- Grand Strand Medical Center - Myrtle Beach, South Carolina, United States
- Parkway Surgery Center - Myrtle Beach, South Carolina, United States
- USA Clinical Trials - San Antonio, Texas, United States
- Northwest Medical Specialties, PLLC - Bonney Lake, Washington, United States
- Northwest Medical Specialties, PLLC - Federal Way, Washington, United States
- Northwest Medical Specialties, PLLC - Gig Harbor, Washington, United States
- Northwest Medical Specialties, PLLC - Puyallup, Washington, United States
- Harborview Medical Center - Seattle, Washington, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- University of Washington Medical Center - Montlake - Seattle, Washington, United States
- Northwest Medical Specialties, PLLC - Tacoma, Washington, United States
- Sbü Gülhane Eğitim Ve Araştirma Hastanesi - Ankara, Turkey (Türkiye)
- Memorial Ankara Hastanesi - Ankara, Turkey (Türkiye)
- Ankara University Health Practice and Research Hospitals - Ankara, Turkey (Türkiye)
- Auckland City Hospital - Auckland, New Zealand
- Peking University Third Hospital - Beijing, China
- CUIMED, s.r.o., Urologicka ambulancia - Bratislava, Slovakia
- IMAXE - Buenos Aires, Argentina
- Centro Medico Fleischer - Buenos Aires, Argentina
- Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne - Clermont-Ferrand, France
- Azienda Socio Sanitaria Territoriale di Cremona - Cremona, Italy
- Hospital Privado Centro Médico de Córdoba - Córdoba, Argentina
- Royal Derby Hospital - Derby, United Kingdom
- National Hospital Organization Kyushu Cancer Center - Fukuoka, Japan
- The Beatson West of Scotland Cancer Centre - Glasgow, United Kingdom
- Universitaetsklinikum Hamburg-Eppendorf - Hamburg, Germany
- Helsinki university hospital - Helsinki, Finland
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
Showing 60 of 236 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →