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Clinical Trials List

Protocol NumberC2321014
NCT Number(ClinicalTrials.gov Identfier)NCT06551324

2024-10-01 - 2029-09-30

Phase III

Recruiting6

ICD-10C61

Malignant neoplasm of prostate

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9185

Malignant neoplasm of prostate

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)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/11/05

Investigators and Locations

Principal Investigator Chuan-Shu Chen Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHUNG-HSIN CHEN Division of Urology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shu-Pin Huang Division of Urology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsiao-Jen Chung Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Jung Su Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Objectives

A trial to investigate the efficacy of the investigational drug PF-06821497 (mevrometostat) in men with mCRPC who had previously received Abiraterone Acetate for prostate cancer. (MEVPRO-1)

Test Drug

PF-06821497 (MEVROMETOSTAT)EnzalutamideDocetaxel

Active Ingredient

PF-06821497
PF-06821497
6808400400
1013000200

Dosage Form

110
132
27C

Dosage

125 mg
250 mg
40mg
80 mg/4 ml

Endpoints

BICR (Blinded Independent Central Review) assessed rPFS according to RECIST (Solid Tumor Response Evaluation Criteria) version 1.1 (soft tissue diseases) and PCWG3 (Prostate Cancer Clinical Trials Working Group 3) (bone diseases).

Inclution 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 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.

Exclusion Criteria

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.
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.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    600 participants

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