RECRUITING

A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

Talk to us

Conditions

Metastatic Castration-Resistant Prostate CancerMEVROMETOSTATMETASTATIC CASTRATION RESISTANT PROSTATE CANCERPF-06821497EZH2enhancer of zeste homologue-2enzalutamidemCRPCProstrate Cancercastrate resistant prostate cancerprostatecancer-study.comefficacysafetypharmacokineticspharmacodynamics

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)

Quick Facts

Study Start:2024-10-22
Study Completion:2028-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06629779

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
  2. * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
  3. * Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  4. * Surgically or medically castrated, with serum testosterone ≤50 ng/dL (≤1.73 nmol/L) at screening.
  5. * Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  6. * Progressive disease in the setting of medical or surgical castration.
  7. * Prior to randomization, there must be resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1.
  8. * ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.
  1. * 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.
  2. * Clinically significant cardiovascular disease.
  3. * Known or suspected brain metastasis or active leptomeningeal disease.
  4. * 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.
  5. * Previous administration with an investigational product (drug or vaccine) within 30 days.
  6. * 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).
  7. * Major surgery or palliative localized radiation therapy within 14 days before randomization.
  8. * Inadequate organ function.

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Arizona Urology Specialists (East Side Location)
Tucson, Arizona, 85715
United States
Arizona Urology Specialists (AUS)-Orange Grove
Tucson, Arizona, 85741
United States
NextStage Clinical Research-Chicago-(04)
Lisle, Illinois, 60532
United States
Adult & Pediatric Urology, PC
Omaha, Nebraska, 68114
United States
AUC Urologists, LLC
Myrtle Beach, South Carolina, 29572
United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
United States
Grand Strand Medical Center
Myrtle Beach, South Carolina, 29572
United States
Parkway Surgery Center
Myrtle Beach, South Carolina, 29572
United States
USA Clinical Trials
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-22
Study Completion Date2028-11-30

Study Record Updates

Study Start Date2024-10-22
Study Completion Date2028-11-30

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Metastatic Castration-Resistant Prostate Cancer