Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors

Stopped early · Phase 2

Conditions studied: Stomach Neoplasms

In brief

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.

Key facts

Study ID

NCT02016534

Run by

Amgen

People needed

60

Starts

2014-02-01

Expected to finish

2016-10-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Seattle, Washington, United States
• Research Site — Camperdown, New South Wales, Australia
• Research Site — Kurralta Park, South Australia, Australia
• Research Site — Bentleigh East, Victoria, Australia
• Research Site — Heidelberg, Victoria, Australia
• Research Site — Innsbruck, Austria
• Research Site — Linz, Austria
• Research Site — Salzburg, Austria
• Research Site — Wels, Austria
• Research Site — Brussels, Belgium
• Research Site — Brussels, Belgium
• Research Site — Charleroi, Belgium
• Research Site — Edegem, Belgium
• Research Site — Ghent, Belgium
• Research Site — Leuven, Belgium
• Research Site — Liège, Belgium
• Research Site — Edmonton, Alberta, Canada
• Research Site — Santiago, Chile
• Research Site — Santiago, Chile
• Research Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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