Phase 2, Parallel-Arm Study of MGCD265 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 93
- 主要终点
- Objective Response Rate
研究概览
简要总结
MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments.
详细描述
If testing has not already been performed, the study will provide for the testing.
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
- •Diagnosis of non-small cell lung cancer
- •Metastatic or locally advanced disease
- •Prior platinum chemotherapy or immunotherapy
- •Test result showing genetic change in MET tumor gene
- •At least one tumor that can be measured on a radiographic scan
排除标准
- •Prior treatment with inhibitor of MET or HGF
- •Prior positive test for EGFR mutation or ALK gene rearrangement
- •Uncontrolled tumor in the brain
研究组 & 干预措施
Arm 1
MGCD265 in patients with MET activating mutations in tumor tissue
干预措施: MGCD265 (Drug)
Arm 2
MGCD265 in patients with MET gene amplifications in tumor tissue
干预措施: MGCD265 (Drug)
Arm 3
MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)
干预措施: MGCD265 (Drug)
Arm 4
MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)
干预措施: MGCD265 (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Up to 3 months
Objective disease response is defined as the percent of patients documented by investigator assessment to have a confirmed Complete Response (CR) or Partial Response (PR) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target and non-target lesions as assessed by CT or MRI. CR is defined as complete disappearance of all target lesions with the exception of nodal disease; PR is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions; Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression; Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.
次要结局
- Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax(Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.)
- Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio(Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.)
- Blood Plasma Concentration of MGCD265 - Tmax(Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.)
- Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations(At baseline)
- Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications(At baseline)
- Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population(At baseline and at time of confirmation of response to treatment)
- Blood Plasma Concentration of Soluble MET (sMET) Biomarker(Cycle 1 and Cycle 2)
- Duration of Response(From date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD, assessed up to 24 months.)
- Progression Free Survival(The time from date of first study treatment to first PD or death due to any cause in the absence of documented PD, up to 24 months.)
- 1-Year Survival Rate(From date of first study treatment to death due to any cause, assessed up to 12 months)
- Overall Survival(From date of first study treatment to death due to any cause, assessed up to 24 months.)
- Number of Patients Experiencing Treatment-emergent Adverse Events(Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.)
- Blood Plasma Concentration of MGCD265 - AUC0-6(Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.)
- Blood Plasma Concentration of MGCD265 - Cmax(Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).)
- Blood Plasma Concentration of MGCD265 - Ctrough(Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).)
- Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6(Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.)