Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,069
- 试验地点
- 259
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 or cytologically proven diagnosis of non-small cell lung cancer
- •positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
- •may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
- •Tumors can be measurable or non measurable
排除标准
- •prior treatment with PF-02341066
- •received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
- •current enrollment in another therapeutic clinical trial
研究组 & 干预措施
PF-0231066
干预措施: PF-02341066 (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 6 years
The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.
Percentage of Participants With Adverse Events
时间窗: 6 years
Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 4.0).
次要结局
- Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182(6 years)
- Duration of Response (DR)(6 years)
- Time to Tumor Response (TTR)(6 years)
- Disease Control Rate (DCR)(6 years)
- Progression Free Survival (PFS)(6 years)
- Overall Survival (OS)(6 years)
- Probability of Survival(6 years)
- Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)(6 years)
- Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)(6 years)
- QTc Prolongation in Participants(6 years)
- Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.(6 years)
- Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores(6 years)
- Mean Change From Baseline of QLQ-LC13 Scale Scores(6 years)
- Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)(6 years)
- Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale(6 years)