A PHASE 1B, OPEN-LABEL, SAFETY AND TOLERABILITY STUDY OF ORAL MDV3100 IN COMBINATION WITH DOCETAXEL IN MEN WITH ADVANCED PROSTATE CANCER
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2
研究概览
简要总结
The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Willing and able to provide informed consent;
- •Men, 18 years of age or older;
- •Histologically or cytologically confirmed adenocarcinoma of the prostate;
- •Ongoing androgen deprivation therapy
排除标准
- •Severe concurrent disease;
- •Known or suspected brain metastasis;
- •History of another malignancy within the previous 5 years;
- •Prior treatment with docetaxel-based chemotherapy
研究组 & 干预措施
MDV3100
干预措施: MDV3100 (Drug)
结局指标
主要结局
Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2
时间窗: Treatment Period 1 (Day 1) up to end of Treatment Period 2 (42 days)
Percentage of participants that required dose reductions of Docetaxel and Enzalutamide treatment were reported in this outcome measure. Dose modifications (interruptions or dose reductions) were permitted for participants who had adverse events that were intolerable or could not be improved by other means. Dose reductions or delays were determined according to the prescribing information and at the discretion of the investigator.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
时间窗: Treatment Period 1 (Day 1) up to end of study treatment (maximum 70 months)
AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Percentage of participants that discontinued study drug due to adverse events were reported in this outcome measure.
次要结局
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5)
- Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECG)(T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5)
- Maximum Plasma Concentration (Cmax) of Docetaxel With and Without Enzalutamide Treatment(Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2)
- Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Docetaxel With and Without Enzalutamide Treatment(Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2)
- Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Docetaxel With and Without Enzalutamide Treatment(Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2)