Trial Title:
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).
NCT ID:
NCT06551324
Condition:
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Conditions: Official terms:
Prostatic Neoplasms
Docetaxel
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PF-06821497
Description:
875 mg BID (2 times a day)
Arm group label:
Arm A
Other name:
Mevrometostat
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
75 mg/m2 IV (every 21 days)
Arm group label:
Arm B
Other name:
Taxotere
Intervention type:
Drug
Intervention name:
Enzalutamide
Description:
160 mg QD
Arm group label:
Arm A
Arm group label:
Arm B
Other name:
XTANDI
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.
Criteria for 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 surgical or medical castration.
- Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life
expectancy of at least 6 months as assessed by the investigator.
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.
- 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, androgen receptor signaling inhibitors (ARSi) including
enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP)
monotherapy or other systemic anti-cancer treatment.
- Inadequate organ function.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NextStage Clinical Research-Chicago-(04)
Address:
City:
Lisle
Zip:
60532
Country:
United States
Status:
Recruiting
Facility:
Name:
Duly Health and Care
Address:
City:
Westmont
Zip:
60559
Country:
United States
Status:
Recruiting
Facility:
Name:
Keystone Urology Specialists
Address:
City:
Lancaster
Zip:
17604
Country:
United States
Status:
Recruiting
Facility:
Name:
Baptist M&S Imaging (Medical Center)
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
USA Clinical Trials
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215004
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Tongji Hospital of Tongji University
Address:
City:
Shanghai
Zip:
200065
Country:
China
Status:
Not yet recruiting
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Cheng Du
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
The first affiliated hospital of Ningbo university
Address:
City:
Ningbo
Zip:
315010
Country:
China
Status:
Recruiting
Facility:
Name:
Chiba cancer center
Address:
City:
Chiba-shi
Zip:
260-8717
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Shikoku Cancer Center
Address:
City:
Matsuyama
Zip:
791-0280
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Hokkaido Cancer Center
Address:
City:
Sapporo
Zip:
003-0804
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hokkaido University Hospital
Address:
City:
Sapporo
Zip:
060-8648
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Kobe University Hospital
Address:
City:
Kobe
Zip:
650-0017
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Yokohama City University Medical Center
Address:
City:
Yokohama
Zip:
232-0024
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yokosuka Kyosai Hospital
Address:
City:
Yokosuka
Zip:
238-8558
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka University Hospital
Address:
City:
Suita
Zip:
565-0871
Country:
Japan
Status:
Recruiting
Facility:
Name:
Keio university hospital
Address:
City:
Shinjuku-ku
Zip:
1608582
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
National Hospital Organization Kyushu Cancer Center
Address:
City:
Fukuoka
Zip:
811-1395
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Kumamoto Medical Center
Address:
City:
Kumamoto
Zip:
860-0008
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yamagata University Hospital
Address:
City:
Yamagata
Zip:
990-9585
Country:
Japan
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Not yet recruiting
Start date:
October 21, 2024
Completion date:
October 29, 2028
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06551324
https://pmiform.com/clinical-trial-info-request?StudyID=C2321014
