A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC
研究概览
简要总结
This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.
详细描述
This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort, where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts, additional patients are included in Expansion Cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy
- •Progressive disease after prior androgen deprivation therapy (medical or surgical castration)
- •For Expansion Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel
- •For Expansion Cohort, the patient must have measurable lesions by RECIST
排除标准
- •Metastases in the brain
- •History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years
- •Use of bicalutamide within 6 weeks prior to study
- •Radiation therapy within 12 weeks prior to study
- •Evidence of serious drug hypersensitivity
研究组 & 干预措施
dose-escalation cohort-1
MDV3100 low dose arm
干预措施: MDV3100 (Drug)
dose-escalation cohort-2
MDV3100 middle dose arm
干预措施: MDV3100 (Drug)
dose-escalation cohort-3
MDV3100 high dose arm
干预措施: MDV3100 (Drug)
dose-expansion cohort
dose expansion with MDV3100 middle dose
干预措施: MDV3100 (Drug)
结局指标
主要结局
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC
时间窗: 3 months during the study
This measure will be assessed on the dose escalation cohorts.
Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Day 85 and end of long term dosing period
This measure will be assessed on the dose expansion cohort
次要结局
- Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG(3 months during the study)
- Prostate Specific Antigen (PSA) Response(Day 85 and end of long term dosing period)