临床试验/NCT03240393

NCT03240393撤回2 期

Phase II Multicenter 3-cohort Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Received 1 or 2 Prior Lines of Systemic Therapy for Advanced/Metastatic Disease

Novartis Pharmaceuticals0 个研究点开始时间: 2018年7月31日最近更新: 2018年7月26日

适应症

干预措施

试验速览

阶段: 2 期
状态: 撤回
发起方: Novartis Pharmaceuticals
主要终点: ORR based on Central Radiology review/assessment (BIRC)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.

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: 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

•Stage IIIB or IV NSCLC (any histology) at the time of study entry
•Histologically or cytologically confirmed diagnosis of NSCLC that is:
•EGFR wt as per patient standard of care by a validated test
•AND ALK-negative rearrangement as part of the patient standard of care by a validated test
•AND (by central assessment) either:
•Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
•Cohort 2: Pre-treated patients with cMET GCN ≥4 and < 6, or
•Cohort 3: Pre-treated patients with cMET mutations regardless of cMET GCN, or
•Patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
•At least one measurable lesion as defined by RECIST 1.1
•Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
•Patients must have adequate organ function
•ECOG performance status (PS) of 0 or 1
•Details and other protocol-defined inclusion criteria may apply

排除标准

•Prior treatment with crizotinib, or any other cMET or HGF inhibitor
•Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
•Patients with characterized ALK-positive rearrangement
•Clinically significant, uncontrolled heart diseases.
•Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
•Strong and moderate inhibitors of CYP3A4
•Strong inducers of CYP3A4
•Impairment of GI function or GI disease that may significantly alter the absorption of INC280
•Patients receiving treatment with any enzyme-inducing anticonvulsant
•Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
•Pregnant or nursing women
•Women of child-bearing potential, unless they are using highly effective methods of contraception
•Sexually active males unless they use a condom during intercourse
•Other protocol-defined exclusion criteria may apply

研究组 & 干预措施

cMET GCN ≥ 6

Experimental

Pre-treated patients with cMET GCN ≥ 6 treated with INC280 at 400mg BID

干预措施: INC280 (Drug)

cMET GCN ≥ 4 and < 6

Experimental

Pre-treated patients with cMET GCN ≥ 4 and < 6 treated with INC280 at 400 mgBID

干预措施: INC280 (Drug)

cMET mutations

Experimental

Pre-treated patients with cMET mutations regardless of cMET GCN treated with INC280 at 400mg BID

干预措施: INC280 (Drug)

结局指标

主要结局

ORR based on Central Radiology review/assessment (BIRC)

时间窗: at least 18 weeks

Proportion of patients with a best overall response defined as complete response (CR) or partial response (PR) by Blinded Independent Review Committee (BIRC) assessment per RECIST 1.1

次要结局

ORR by Investigator(at least 18 weeks)
Disease Control Rate (DCR) by BIRC(at least 18 weeks)
Progression-free Survival (PFS) by BIRC(at least 18 weeks)
Progression-free Survival (PFS) by investigator(at least 18 weeks)
Duration of Response (DOR) by investigator(at least 18 weeks)
Overall Survival (OS)(at least 18 weeks)
Cmax profile of INC280(6 weeks)
Cmin profile of INC280(6 weeks)
Duration of Response (DOR) by BIRC - Key Secondary(at least 18 weeks)
Cmax profile of INC280 metabolite CMN288(6 weeks)
Time to Response (TTR) by BIRC(at least 18 weeks)
Time to Response (TTR) by investigator(at least 18 weeks)
Cmin profile of INC280 metabolite CMN288(6 weeks)
Disease Control Rate (DCR) by investigator(at least 18 weeks)
Plasma concentration-time profiles of INC280(6 weeks)
Plasma concentration-time profiles of INC280 metabolite CMN288(6 weeks)

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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