NCT01070927已完成2 期
An Exploratory Study on Anti-tumour Activity of Orally Administered RO4929097, a Gamma-secretase Inhibitor, as a Single Agent in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer (NSCLC).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 主要终点
- Tumour blood flow and tumour metabolic response rate
研究概览
简要总结
This study will evaluate the anti-tumour activity, safety and tolerability of RO4929097 as monotherapy in patients with recurrent or refractory non-small cell lung cancer. Patients will receive oral doses of RO4929097 of 80mg (cohort 1) or recommended Phase II dose (cohort 2) on a 3 days on 4 days off schedule. Anticipated time on study treatment is until disease progression or unacceptable toxicity. Target sample size is <50.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >/= 18 years of age
- •stage IIIB/IV recurrent or refractory non-small cell lung cancer
- •at most 2 lines of prior therapy in the metastatic setting (first line: platinum containing regimen and bevacizumab; second line: EGFR-targeted therapy)
- •ECOG performance status 0-2
- •adequate liver, renal and bone marrow function
排除标准
- •prior chemotherapy or radiotherapy </= 4 weeks before first dose of study drug
- •history of other malignancy within the past 2 years, except for basal cell skin carcinoma or in situ cervical carcinoma
- •history of CNS metastases or leptomeningeal metastases, except for clinically stable disease
- •serious cardiovascular illness
研究组 & 干预措施
cohort 1
Experimental
干预措施: RO4929097 (Drug)
cohort 2
Experimental
干预措施: RO4929097 (Drug)
结局指标
主要结局
Tumour blood flow and tumour metabolic response rate
时间窗: PET and CT assessments on day 4 (cycle 1) and day 16 (cycles 1 and 2)
次要结局
- Pharmacokinetic profile and pharmacodynamic parameters (e.g. changes in circulating endothelial and hematopoietic precursors)(pharmacokinetics: cycle 1 on days 1, 2, 4, 10, 11, 16; cycle 2 on days 1, 2, 16\npharmacodynamics: cycle 1 on days 1, 2, 4, 11, 16; cycle 2 on days 1, 16)
- Tumour response according to RECIST criteria(assessments once every 2nd cycle on day 16)
- Safety and tolerability: AEs, laboratory parameters(throughout study, laboratory assessments on days 1, 8 and 15 of each cycle)
研究者
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