This trial is active, not recruiting.

Condition stomach neoplasms
Treatment amg 337
Phase phase 2
Target c-MET
Sponsor Amgen
Start date February 2014
End date January 2017
Trial size 60 participants
Trial identifier NCT02016534, 2013-001277-24, 20130111


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
AMG 337 Monotherapy
amg 337
AMG 337 300mg orally daily.

Primary Outcomes

Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)
time frame: 2.5 years

Secondary Outcomes

Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
time frame: 2.5 years
Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)
time frame: 2.5 years
Progression free survival
time frame: 2.5 years
Overall survival
time frame: 2.5 years
Incidence and severity of adverse events and significant laboratory abnormalities
time frame: 2.5 years
AMG 337 exposure and dose intensity
time frame: 2.5 years
Pharmacokinetic parameters
time frame: 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).
time frame: 2.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Additional Information

Official title 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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Amgen.
Location data was received from the National Cancer Institute and was last updated in June 2016.