EUCTR2009-013174-41-AT进行中（未招募）1 期
AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy - AFFIRM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,199
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •-Progressive prostate cancer;
- •-One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel;
- •-Medical or surgical castration with a testosterone level < 1.7 nmol/L (50 ng/dL);
- •-ECOG performance status of 0-2;
- •-Adequate bone marrow, hepatic, and renal function;
- •-Able to swallow the study drug and comply with study requirements;
- •-Willing and able to give informed consent.
- •Open-Label Extension Criteria for Patients Randomized to the Placebo
- •Arm Patients randomized to the placebo arm of the blinded portion of
- •the study must meet the following inclusion criteria:
- •-Willing and able to give informed consent;
- •-No more than a total of two prior chemotherapy regimens;
- •-ECOG performance status of 0–2;
- •-Able to swallow the study drug and comply with study requirements;
- •Open-Label Extension Eligibility Criteria for Patients Continuing
- •MDV3100 Patients continuing MDV3100 must meet the following
- •XML File Identifier: sKc+J3reEJrmGIlUpi9R8+oWEK4=
- •eligibility criterion:
- •-Willing and able to give informed consent for open-label extension
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 359
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 840
排除标准
- •-Metastases in the brain or active epidural disease;
- •-Another malignancy within the previous 5 years;
- •-Clinically significant cardiovascular disease;
- •-Gastrointestinal disorder affecting absorption.
- •Open-Label Extension Criteria for Patients Randomized to the Placebo
- •Patients randomized to the placebo arm of the blinded portion of the
- •study must NOT meet any of the following exclusion criteria:
- •-Known or suspected brain metastasis;
- •-Clinically significant cardiovascular disease including
研究者
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