NCT00420186已完成1 期
A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With Paclitaxel and Carboplatin for Patients With Advanced or Metastatic Solid Tumors
Bristol-Myers Squibb3 个研究点 分布在 2 个国家目标入组 37 人开始时间: 2007年10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
- 37
- 试验地点
- 3
- 主要终点
- To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation
研究概览
简要总结
The purpose of this clinical research is to assess the safety and tolerability of BMS-690514 when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with Paclitaxel and carboplatin
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced or metastatic solid tumors for whom paclitaxel/carboplatin is considered an appropriate therapy
- •Centrally located squamous cell carcinoma of the lung is permitted
- •ECOG performance status of 0-1
- •Life expectancy of at least 3 months
- •Men and women age 18 and above
排除标准
- •Symptomatic brain metastases. Patients with signs for symptoms of brain metastases are ineligible unless brain metastases are ruled out by CT or MRI
- •Peripheral neuropathy ≥Grade 1 for any reason
- •History of thromboembolic disease or bleeding diatheses within the last 6 months
- •Women of child bearing potential without adequate contraception, breastfeeding, or pregnant
- •Serious, uncontrolled medical disorder or active infection
- •Uncontrolled or significant cardiac disease
- •Uncontrolled hypertension (150/100)
- •Allergy to Cremophor EL®
研究组 & 干预措施
1
Experimental
干预措施: BMS-690514 (Drug)
结局指标
主要结局
To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation
时间窗: upon occurrence
次要结局
- Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research(upon occurence)
- Describe anti-tumor activity(upon occurence)
研究者
研究点 (3)
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