A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
a study on Metastatic Castration-Resistant Prostate Cancer Prostate Cancer
Summary
- Eligibility
- for males ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedstudy ends around
Description
Summary
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.
Official Title
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)
Keywords
Metastatic Castrate Resistant Prostate Cancer (mCRPC), Prostate cancer, Enhancer of zeste homolog 2, castrate resistant prostate cancer, Hormone resistant, Metastatic hormone resistant prostate cancer, Metastatic castrate resistant prostate cancer, PF-06821497, Enzalutamide, Docetaxel, Advanced prostate cancer, Efficacy, Safety, Open-label, Relapsed, refractory, Prostatic Neoplasms, Recurrence, PF06821497
Eligibility
You can join if…
Open to males ages 18 years and up
- 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 surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
- Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
You CAN'T join if...
- 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 or other systemic anti-cancer treatment, with the following exceptions:
- Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
- 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 within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
- Inadequate organ function.
Locations
- UCSF Cancer Center Berkeley
accepting new patients
Berkeley 5327684 California 5332921 94702 United States - UCSF Cancer Center Burlingame
accepting new patients
Burlingame 5331920 California 5332921 94010 United States - UCSF Investigational Drug Pharmacy
accepting new patients
San Francisco 5391959 California 5332921 94158 United States - UCSF Medical Center at Mission Bay
accepting new patients
San Francisco 5391959 California 5332921 94158 United States - UCSF Cancer Center San Mateo
accepting new patients
San Mateo 5392423 California 5332921 94402 United States - Los Angeles Cancer Network
accepting new patients
Los Angeles 5368361 California 5332921 90067 United States - Los Angeles Cancer Network
accepting new patients
Fountain Valley 5350207 California 5332921 92708 United States - Los Angeles Cancer Network
accepting new patients
Los Angeles 5368361 California 5332921 90017 United States - Los Angeles Cancer Network
accepting new patients
Glendale 5352423 California 5332921 91204 United States - Los Angeles Cancer Network
accepting new patients
Glendale 5352423 California 5332921 91206 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Pfizer
- ID
- NCT06551324
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 600 study participants
- Last Updated