Details
Description
Inclusion Criteria
Exclusion Criteria
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
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.
- 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.
- 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
- 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
- Male or female subjects ≥18 years of age at the time of enrollment
- Subjects must have a pathologically confirmed advanced (locally advanced or metastatic) G/GEJ/E adenocarcinoma or other solid tumor types to be specified
- Subject has available either recent (preferred) or archival tumor tissue sufficient for submission to the central laboratory for MET-amplification testing
- Chemotherapy-naive subjects and those with any number of prior lines of chemotherapy are allowed.
Exclusion Criteria
- Early disease with the potential for cure by surgical resection or definitive chemoradiation
- Subject previously has entered this study