NCT00779428已完成2 期
Phase 2 Clinical Trial of Tanespimycin in Patients With Advanced Malignancies After Failure of Previous Anti-cancer Therapy Regimens Who Have Participated on a Prior Protocol Investigating Tanespimycin
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- There is no Primary Outcome
研究概览
简要总结
The primary purpose of this study is to provide treatment to patients who have participated on a prior protocol investigating Tanespimycin (KOS-953,17-AAG)
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
- •Age >= 18 years
- •Participated in and completed a previous Tanespimycin protocol without evidence of unacceptable toxicity and is deemed by the Investigator to be deriving benefit from the Tanespimycin drug as defined in the previous protocol
- •All patients must rollover to this continuation protocol within 30 days of the last dose of Tanespimycin in the previous protocol, unless previously approved by the Medical Monitor
- •All Adverse Events from the prior protocol, must have resolved to NCI CTCAE (v. 3.0) Grade <= 2
- •The following laboratory results, within 10 days of Tanespimycin administration:
- •Hemoglobin >= 8 g/dL
- •Absolute neutrophils count >= 1.0x 10*9* /L
- •Platelet count >= 50 x 10*9* /L
- •Serum bilirubin <= 2 x ULN
- •AST <= 2.5 ULN
- •Serum creatinine <= 2 x ULN
- •ECOG performance status of 0, 1 or 2
- •Signed informed consent
排除标准
- •Pre-existing neuropathy of CTCAE Grade >= 3 due to any cause
- •Documented hypersensitivity reaction of CTCAE Grade >= 3 to prior therapy containing Cremophor (for those patients receiving Tanespimycin Injection)
- •Pregnant or breast-feeding women
- •Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic), excluding Tanespimycin within 21 days prior to receipt of study medication
- •Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient
研究组 & 干预措施
A1
Experimental
干预措施: Tanespimycin (Drug)
结局指标
主要结局
There is no Primary Outcome
时间窗: No formal analysis of efficacy will occur
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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