EUCTR2009-013174-41-BE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
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 of the blinded portion. 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 eligibility criterion:
- •- Willing and able to give informed consent for open-label extension period.
- •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 arm:
- •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
研究者
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