A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 80
- 主要终点
- Progression-free survival (PFS) in the randomized population
研究概览
简要总结
This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS mutant lung cancer. Following 8 weeks of open-label ridaforolimus lead-in there will be an assessment of disease status. Patients assessed by the investigator to have stable disease after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo. Patients assessed to have partial or complete response will continue on open-label ridaforolimus. Patients assessed to have disease progression will be discontinued from study.
详细描述
Allocation and Arms Additional Information: All Patients will receive an 8-week
open-label lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed for disease status. Patients who are stable after 8 weeks are randomized in a double-blind fashion to continue treatment with ridaforolimus or to a placebo until disease progression. (Those patients who have stable disease but are randomized to placebo may cross-over to open-label ridaforolimus at the time of disease progression.)
Those patients with tumor shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus, while those patients who have disease progression at 8-weeks are taken off-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
- Double (Participant, Investigator)
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
- •Patient has histologically confirmed stage IIIB/IV non-small cell lung cancer
- •Patient has a documented mutation of the KRAS gene
- •Patient has evidence of disease progression following 1 but no more than 3 prior chemotherapy regimens
- •A minimum of 4 weeks has passed since the most recent anti-cancer treatment
- •Women of childbearing potential must have a negative pregnancy test prior to start of therapy and must use an approved contraceptive method for the duration of the study
- •Patient has adequate organ function
- •Patient has performance status of <=2 on Eastern Cooperative Oncology Group (ECOG) performance scale
- •Patient is >=18 years of age
排除标准
- •Patient has received more than 2 prior chemotherapy regimens for the treatment lung cancer
- •Patient is known to have active brain metastases
- •Patient is currently participating or has participated in an investigational drug study within 30 days
- •Patient is known to be Human Immunodeficiency Virus (HIV) positive or has a known history of Hepatitis B or C
- •Patient has an active infection requiring prescribed intervention
- •Patient has newly diagnosed or un-controlled Type 1 or 2 diabetes
研究组 & 干预措施
Ridaforolimus
干预措施: Lead-In Ridaforolimus (Drug)
Placebo
干预措施: Lead-In Ridaforolimus (Drug)
结局指标
主要结局
Progression-free survival (PFS) in the randomized population
时间窗: Randomization (Week 8) and every 8 weeks until progressive disease or death
次要结局
- PFS in the full analysis population(Study entry (Visit 1) and every 8 weeks until progressive disease or death)
- Overall response rate (ORR) in the full analysis population(Study entry (Visit 1) and every 8 weeks until progressive disease or death)
- OS in the randomized population(From study entry (Visit 1) to death due to any cause)
- Overall survival (OS) in the full analysis population(From study entry (Visit 1) to death due to any cause)