NCT02016534

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	AMG 337	AMG 337 300mg orally daily.

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-12-20
• Last updated: 2017-07-02

Locations

97 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hungary, Italy, Peru, Poland, Russia, South Korea, Spain, United Kingdom