jRCT2011240048招募中不适用
A Phase 3, Randomized, Double Blind, Placebo Controlled Study of Pf-06821497 (Mevrometostat) With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (Mevpro-2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 主要终点
- Radiographic Progression Free Survival (rPFS)
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
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •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 <=
- •ECOG performance status 0 or 1, with a life expectancy of >=12 months as assessed by the investigator.
排除标准
- •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 naive 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.
结局指标
主要结局
Radiographic Progression Free Survival (rPFS)
时间窗: Randomization up to approximately 3 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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