NCT00974311已完成3 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,199
- 试验地点
- 220
- 主要终点
- Overall Survival
研究概览
简要总结
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Progressive prostate cancer
- •Medical or surgical castration with testosterone less than 50 ng/dl
- •One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate bone marrow, hepatic, and renal function
- •Able to swallow the study drug and comply with study requirements
- •Informed consent
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
研究组 & 干预措施
Enzalutamide
Experimental
Formerly MDV3100
干预措施: Enzalutamide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: During study period (up to 101 months)
Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).
次要结局
- Radiographic Progression-free Survival(During DB phase (up to 24 months))
- Time to First Skeletal-related Event(During DB Phase (up to 24 months))
- Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)(Baseline up to 24 months)
- Time to Prostate-specific Antigen (PSA) Progression(Baseline and at every study visit from Week 13 while on study drug (up to 24 months))
- Percentage of Participants With Pain Palliation(Baseline up to 24 months)
- Percentage of Participants With Prostate Specific Antigen (PSA) Response(During DB phase (up to 24 months))
- Percentage of Participants With Soft-tissue Objective Response(During DB phase (up to 24 months))
- European Quality of Life Five-Domain (EQ-5D) Scale(Week 13)
- Percentage of Participants With Circulating Tumor Cell (CTC) Conversion(Baseline up to 24 months)
研究者
研究点 (220)
Loading locations...
相似试验
进行中（未招募）
3 期
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum ChemotherapyPlatinum SensitiveBRCA MutatedRelapsed Ovarian CancerFollowing Complete or Partial Response to Platinum Based ChemotherapyNCT01874353AstraZeneca327
已完成
3 期
A Study to Evaluate the Efficacy and Safety of AK102 in Patients With HyperlipidemiaHyperlipidemiaNCT05255094Akeso464
Unknown
3 期
Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal CancerEsophageal CancerNCT04426955Jiangsu HengRui Medicine Co., Ltd.396
进行中（未招募）
3 期
A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast CancerMetastatic Breast CancerNCT03863223Jiangsu HengRui Medicine Co., Ltd.590
招募中
3 期
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)Sickle Cell DiseaseNCT06439082Novartis Pharmaceuticals354