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临床试验/jRCT2051240128
jRCT2051240128招募中不适用

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)

Pfizer Japan Inc.0 个研究点目标入组 600 人开始时间: 2024年10月22日最近更新:
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试验速览

阶段
不适用
状态
招募中
入组人数
600
主要终点
Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit（—）
性别
Male

入选标准

  • •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.
  • •Surgically or medically castrated, with serum testosterone <=50 ng/dL (<=1.73 nmol/L) at screening.
  • •Progressive disease in the setting of surgical or medical castration. Note: Evidence of disease progression with at least 12 weeks of abiraterone acetate in the metastatic castrate sensitive prostate cancer (mCSPC) setting, or first line metastatic castrate resistant prostate cancer (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.

排除标准

  • •Exclusion Criteria:
  • •Any medical (including active or clinically significant bacterial, fungal or viral infection) 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.
  • •Central nervous system (CNS) pathology/neurological findings including known or suspected brain metastasis or active leptomeningeal disease, symptomatic or impending spinal cord compression or cauda equina syndrome, or clinically significant history of seizure or any condition that may predispose to 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 (approved drugs or experimental compounds such as, antibody therapy, immunotherapy, gene therapy, angiogenesis inhibitors, EZH2 inhibitors).
  • •Inadequate renal function defined by an estimated glomerular filtration rate (eGFR) <45 mL/min.
  • •Hepatic dysfunction.
  • •Hematologic abnormalities

结局指标

主要结局

Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

时间窗: Randomization up to approximately 2 years.

rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.

次要结局

未报告次要终点

研究者

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