An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 33
- 主要终点
- Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12
研究概览
简要总结
The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically confirmed NSCLC with activated PI3K pathway
- •Progressive disease after prior systemic antineoplastic treatment(s) for advanced NSCLC
- •Archival or fresh tumor biopsy must be available for profiling
- •Measurable and/or non-measurable disease as per RECIST 1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Adequate organ function as assessed by laboratory tests
排除标准
- •Patient has received previous treatment with PI3K inhibitors
- •Patient with squamous NSCLC has received more than one line of chemotherapy treatment for metastatic disease; patient with non-squamous NSCLC has received more than two lines of systemic antineoplastic treatment for metastatic disease
- •Uncontrolled or symptomatic CNS metastases
- •Concurrent use of any other approved or investigational antineoplastic agent
- •Radiotherapy ≤ 28 days prior to starting study drug
- •Major surgery within 28 days prior to starting study drug
- •History of clinically significant cardiac dysfunction, mood disorders, or poorly controlled diabetes mellitus
- •Current treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes
- •Impairment of gastrointestinal (GI) function
- •Chronic treatment with steroids or another immunosuppressive agent.
- •Concurrent severe and/or uncontrolled medical condition
- •Currently receiving Warfarin or another coumarin derivative
- •Known history of HIV infection
- •Sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
- •Pregnancy, lactation, or breastfeeding
- •Woman of child-bearing potential
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Squamous BKM120 100mg qd
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
干预措施: BKM120 (Drug)
Non-Squamous BKM120 100mg qd
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
干预措施: BKM120 (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12
时间窗: Week 12
PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a "success" for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate \<50% at 12 weeks was observed. No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group.
次要结局
- Overall Survival (OS) Using Kaplan-Meier Estimates(Every 8 weeks up to 24 months)
- Overall Response Rate (ORR) Based on Investigator Assessment(Every 6 weeks up to 24 months)
- Disease Control Rate (DCR)(Every 6 weeks up tp 24 months)
- Time to Response (TTR)(Every 6 weeks up to 24 months)
- Duration of Response (DoR)(Every 6 weeks up to 24 months)