A Multicenter, Phase 2, Single Arm, Two Cohort Study Evaluating the Efficacy, Safety, and Pharmacokinetics of AMG337 in Subjects With MET Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma or Other MET Amplified Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)
研究概览
简要总结
This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.
详细描述
This is a phase 2, multicenter, single arm, 2 cohort study to assess the safety, efficacy and pharmacokinetics of AMG 337 in MET amplified Gastric/esophageal adenocarcinoma or other solid tumors. Approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified G/E adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor/up to 10 subjects with MET amplified G/E adenocarcinoma with non-measurable tumor/up to 10 subjects who have received prior MET antibody therapy). All subjects will self-administer AMG 337 300 mg daily until disease progression or other protocol specified end of treatment criteria is met.
Tumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be assessed.
Tumor assessment by RECIST 1.1 will be followed during study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Able to daily self-administer AMG 337 orally as a whole capsule
- •Male or female 18 years of age or over.
- •Pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy
- •Tumor MET amplified by protocol-specified centralized testing.
- •Measurable disease per RECIST 1.1 guidelines. Cohort 2 may include up to 10 subjects with advanced MET amplified, G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1
- •(ECOG) Performance Status of 0, 1 or 2
排除标准
- •Known central nervous system metastases
- •Candidate for curative surgery or definitive chemoradiation
- •Peripheral edema > grade 1
- •Persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. Significant gastrointestinal disorder(s) that in the opinion of the Investigator may influence drug absorption
- •Acute Hepatitis B. Chronic Hepatitis B eligible if condition is stable and, in the opinion of the investigator or Amgen physician, if consulted, would not pose a risk to subject safety
- •Detectable Hepatitis C virus (indicative of active Hepatitis C)
- •Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment
- •Prior treatment with small molecule inhibitors of the MET pathway.
- •Other protocol defined inclusion criteria may apply.
研究组 & 干预措施
Single arm
AMG 337 Monotherapy
干预措施: AMG 337 (Drug)
结局指标
主要结局
Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)
时间窗: 2.5 years
Determine antitumor activity of AMG 337 in subjects with MET amplified G/GEJ/E adenocarcinoma
次要结局
- Progression free survival(2.5 years)
- Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)(2.5 years)
- Overall survival(2.5 years)
- Incidence and severity of adverse events and significant laboratory abnormalities(2.5 years)
- Pharmacokinetic parameters(2.5 years)
- Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)(2.5 years)
- Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2).(2.5 years)
- AMG 337 exposure and dose intensity(2.5 years)