Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT02096666
Eligibility Criteria:
Inclusion Criteria:
* Able to self administer daily AMG 337 as a whole capsule
* Male or female 20 years of age or over
* Phase 1: Subjects must have a pathologically confirmed, advanced solid tumor for which the subjects have received prior therapy for advanced disease, for which no standard therapy exists, or the subject refuses standard therapy.
* Phase 2: Subjects must have a pathologically confirmed, advanced G/GEJ/E adenocarcinoma (cohort 1) or other solid tumor (cohort 2) for which the subjects have received prior therapy for advanced disease, or for which no standard therapy exists, or the subject refuses standard therapy.
* Tumor MET amplified by protocol-specified centralized testing (phase 2 only).
* Phase 1: Measurable or non-measurable disease per RECIST v1.1
* Phase 2: Measurable disease per RECIST v1.1 guidelines. Cohort 2 may include 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
* Other protocol defined inclusion criteria may apply.
Exclusion Criteria:
* Known central nervous system metastases.
* Subject is a candidate for curative surgery or definitive chemoradiation.
* Peripheral edema \> grade 1.
* Subjects who have 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.
* 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 exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02096666
Study Brief:
Protocol Section:
NCT02096666