NCT00644488已完成1 期
A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
研究概览
简要总结
The purpose of this clinical study is to assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients with castration-resistant prostate cancer and serum testosterone ≤50 ng/dL progressive to current therapy who satisfy the inclusion and exclusion criteria
排除标准
- 未提供
研究组 & 干预措施
A1
Experimental
Active
干预措施: BMS-641988 (AR#2) (Drug)
结局指标
主要结局
To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
时间窗: throughout the study
次要结局
- To evaluate the pharmacokinetics of BMS-641988 and the metabolites BMS-501949 and BMS-570511(at cycle 1 day 1, day 15 and day 29)
- To identify the dose(s) of BMS-641988 for Phase II(at the end of study)
- To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans(throughout the study)
- To assess the effects of BMS-641988 on pharmacodynamic markers (LH, total and free testosterone, 5(alpha)-DHT, estradiol, prolactin, FSH, and SHBG)(throughout the study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase I Study of BMS-690514 in Japanese Patients With Solid TumorsCancerNCT00516451Bristol-Myers Squibb9
已完成
3 期
An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe PsoriasisPsoriasisNCT03924427Bristol-Myers Squibb74
终止
1 期
A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced MalignanciesTumorsNCT00207025Bristol-Myers Squibb60
已完成
1 期
To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese ParticipantsThrombosisNCT03224260Bristol-Myers Squibb33
已完成
1 期
A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid TumorsAdvanced Solid TumorsNCT05625412Bristol-Myers Squibb70