Trial Title:
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
NCT ID:
NCT06629779
Condition:
Metastatic Castration-Resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
MEVROMETOSTAT
METASTATIC CASTRATION RESISTANT PROSTATE CANCER
PF-06821497
EZH2
enhancer of zeste homologue-2
enzalutamide
mCRPC
Prostrate Cancer
castrate resistant prostate cancer
prostatecancer-study.com
efficacy
safety
pharmacokinetics
pharmacodynamics
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
This is a double-blind study. Participants will receive PF-06821497 or matching placebo
in a blinded fashion, as indicated in Section 6.1. Participants, investigators and site
staff, and sponsor staff will be aware that participants in both study arms are receiving
enzalutamide. Enzalutamide will be provided in an open-label manner to participants in
each treatment arm.
Participants and their caregivers will be blinded to their assigned study intervention.
Investigators and other site staff will be blinded to participants' assigned study
intervention Sponsor staff will be blinded to participants' assigned study intervention,
except for sponsor staff involved in the assignment or distribution of study
intervention.
Intervention:
Intervention type:
Drug
Intervention name:
PF-06821497
Description:
Oral continuous
Arm group label:
Arm A
Other name:
Mevrometostat
Intervention type:
Drug
Intervention name:
Placebo
Description:
Oral continuous
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Enzalutamide
Description:
Oral continuous
Arm group label:
Arm A
Arm group label:
Arm B
Other name:
Xtandi
Summary:
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.
Detailed description:
This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497
(mevrometostat) in combination with enzalutamide versus placebo in combination with
enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have
been initiated after documentation of mCRPC with the exception of ADT (androgen
deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any
of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not
permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting.
This study consists of a Screening Phase, Randomization, Treatment Phase, Safety
Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to
receive (Arm A) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in
combination with enzalutamide.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male participants aged ≥18 years (or the minimum age of consent in accordance with
local regulations) at screening.
- 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.
- Surgically or medically castrated, with serum testosterone ≤50 ng/dL (≤1.73 nmol/L)
at screening.
- 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.
- Prior to randomization, there must be resolution of acute effects of any prior
therapy to either baseline severity or CTCAE Grade ≤1.
- 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/behavior or laboratory abnormality that may increase the
risk of study participation or, in the investigator's judgment, make the participant
inappropriate for the study.
- Clinically significant cardiovascular disease.
- Known or suspected brain metastasis or active leptomeningeal disease.
- Participants must be treatment naïve at the mCRPC stage, eg, participants cannot
have received any cytotoxic chemotherapy with the following exceptions: Treatment
with first-generation antiandrogen (ADT) agents and. Docetaxel treatment is allowed
for mCSPC.
- Previous administration with an investigational product (drug or vaccine) within 30
days.
- Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors
and inducers (with exception of enzalutamide as part of this study).
- Major surgery or palliative localized radiation therapy within 14 days before
randomization.
- Inadequate organ function.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona Urology Specialists (East Side Location)
Address:
City:
Tucson
Zip:
85715
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Arizona Urology Specialists (AUS)-Orange Grove
Address:
City:
Tucson
Zip:
85741
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Duly Health and Care (Bone Scintigraphy)
Address:
City:
Lisle
Zip:
60532
Country:
United States
Status:
Recruiting
Facility:
Name:
NextStage Clinical Research-Chicago-(04)
Address:
City:
Lisle
Zip:
60532
Country:
United States
Status:
Recruiting
Facility:
Name:
Duly Health and Care (CT and MRI)
Address:
City:
Westmont
Zip:
60559
Country:
United States
Status:
Recruiting
Facility:
Name:
Adult & Pediatric Urology, PC
Address:
City:
Omaha
Zip:
68114
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:
Huai'an First People's Hospital
Address:
City:
Huai'an
Zip:
223300
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:
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:
Recruiting
Facility:
Name:
National Hospital Organization Kyushu Cancer Center
Address:
City:
Fukuoka
Zip:
811-1395
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
National Hospital Organization Kumamoto Medical Center
Address:
City:
Kumamoto
Zip:
860-0008
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yamagata University Hospital
Address:
City:
Yamagata
Zip:
990-9585
Country:
Japan
Status:
Recruiting
Start date:
October 22, 2024
Completion date:
November 30, 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/NCT06629779
https://pmiform.com/clinical-trial-info-request?StudyID=C2321003
