A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Stage IIIb or IV Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 385
- 试验地点
- 4
- 主要终点
- Progression-free survival in two co-primary populations
研究概览
简要总结
The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer.
详细描述
Preliminary signals of clinical activity of ganetespib as a single agent have been observed in NSCLC. A novel approach to treatment of NSCLC is the combination of Hsp90 inhibitors, such as ganetespib, and taxanes. Such combinations have shown potential for synergy in preclinical and clinical evaluations with other Hsp90 inhibitors. Preclinical studies with ganetespib and taxanes have indicated that the combination of these drugs was more effective than either drug alone at inducing cell death, and an ongoing phase 1 study indicates that the combination is well tolerated and warrants systematic evaluation in a larger study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •confirmed diagnosis of NSCLC
- •Stage IIIB or IV NSCLC
- •ECOG Performance Status 0 or 1
- •Prior therapy defined as 1 prior systemic therapy for advanced disease
- •measurable disease
- •Radiologic evidence of disease progression following most recent prior treatment.
- •Adequate hematologic, hepatic, renal function
排除标准
- •Active or untreated CNS metastases
- •Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
- •Serious cardiac illness or medical conditions
- •Pregnant or lactating women
- •Uncontrolled intercurrent illness
研究组 & 干预措施
Single agent docetaxel
干预措施: Docetaxel (Drug)
Combination of ganetespib and docetaxel
干预措施: Combination of ganetespib and docetaxel (Drug)
结局指标
主要结局
Progression-free survival in two co-primary populations
时间窗: 14 months
次要结局
- Determine plasma drug concentrations of the combination(14 months)
- Evaluate Quality of Life(14 months)
- Determine qualitative and quantitative toxicities(14 months)
- Disease Control Rate(14 months)
- Overall Response Rate(14 months)
- Tumor size change(14 months)
- Overall survival(21 months)