Details

Details

Title Identification and Characterization of Molecular and Clinical Profiles, and Outcomes in Subjects With MET-Amplified Cancers

IRB AMGN1214

CC 14-933

Hospital Main Campus

Disease All Cancer Types

Description

Description

Primary Objectives
  • Estimate the prevalence of subjects with MET-amplified tumors in advanced gastric/gastroesophageal junction/esophageal adenocarcinoma (G/GEJ/E) and other cancer tumor types to be specified.
  • Screen subjects for MET-amplified tumors for potential treatment in AMG 337 (MET tyrosine kinase inhibitor) therapeutic trials.
Secondary Objectives
  • Describe the demographic and clinical characteristics of subjects who have MET-amplified and non-MET-amplified tumors, and evaluate the clinical course in advanced G/GEJ/E subjects including outcomes to therapy (objective response rate [ORR], progression-free survival [PFS], and overall survival [OS]) in subjects with MET-amplified and subjects with non-MET-amplified tumors.
Exploratory Objectives
  • Evaluation of other biomarkers in tumors and blood samples including but not limited to MET expression, MET mutations and HER 2 status and their association with other baseline characteristics and outcome.
Inclusion Criteria

Inclusion Criteria

  1. Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent
  2. Male or female subjects ≥18 years of age at the time of enrollment
  3. Subjects must have a pathologically confirmed advanced (locally advanced or metastatic) G/GEJ/E adenocarcinoma or other solid tumor types to be specified
  4. Subject has available either recent (preferred) or archival tumor tissue sufficient for submission to the central laboratory for MET-amplification testing
  5. Chemotherapy-naive subjects and those with any number of prior lines of chemotherapy are allowed.
Exclusion Criteria

Exclusion Criteria

  1. Early disease with the potential for cure by surgical resection or definitive chemoradiation
  2. Subject previously has entered this study