Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Berkeley, California and other locations
Dates
study started
completion 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

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:
    1. Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
    2. 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 not yet accepting patients
    Berkeley California 94702 United States
  • UCSF Cancer Center Burlingame not yet accepting patients
    Burlingame California 94010 United States
  • UCSF Investigational Drug Pharmacy not yet accepting patients
    San Francisco California 94158 United States
  • UCSF Medical Center at Mission Bay not yet accepting patients
    San Francisco California 94158 United States
  • UCSF Cancer Center San Mateo not yet accepting patients
    San Mateo California 94402 United States
  • Sutter Santa Rosa accepting new patients
    Santa Rosa California 95403 United States
  • Huntsman Cancer Institute accepting new patients
    Salt Lake City Utah 84112 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT06551324
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated