Overview

This trial is active, not recruiting.

Condition stomach neoplasms
Treatment amg 337
Phase phase 1/phase 2
Target c-MET
Sponsor Amgen
Start date April 2014
End date November 2015
Trial size 11 participants
Trial identifier NCT02096666, 20120370

Summary

This is a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal adenocarcinoma (Phase 2).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
amg 337
Phase 1- AMG 337 150 mg, 200mg and 300 mg orally daily. Additional 150 mg and 200 mg orally twice daily. Phase 2- AMG 337 (dose determined by Phase 1)

Primary Outcomes

Measure
Phase 1- Adverse events and clinical laboratory abnormalities
time frame: 17 months
Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with MET amplified measurable gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)
time frame: 17 months

Secondary Outcomes

Measure
Phase 1- Pharmacokinetic parameters
time frame: 17 months
Phase 1- Other adverse events, clinical laboratory abnormalities and ECG parameters
time frame: 17 months
Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2)
time frame: 17 months
Phase 2- Duration of Response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
time frame: 17 months
Phase 2- Time to response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
time frame: 17 months
Phase 2- Progression Free Survival
time frame: 17 months
Phase 2- Overall Survival
time frame: 17 months
Phase 2- Incidence and severity of adverse events and significant laboratory abnormalities
time frame: 17 months
Phase 2- AMG 337 exposure and dose intensity
time frame: 17 months
Phase 2- Pharmacokinetic parameters
time frame: 17 months
Phase 1- Overall Response Rate
time frame: 17 months
Phase 1- Duration of Response
time frame: 17 months
Phase 1- Time to Response
time frame: 17 months
Phase 1- Progression-Free Survival (per RECIST v1.1)
time frame: 17 months
Phase 1- Overall Survival
time frame: 17 months

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title A Multicenter, Phase 1/2, Open-Label Study Evaluating the Tolerability, Safety, Pharmacokinetics, and Efficacy of AMG 337 in Asian Subjects
Description This is a Phase 1/2, multicenter, single arm, open-label study to assess the safety, efficacy and pharmacokinetics of AMG 337 in solid tumors. In the Phase 1, approximately 3 to 45 subjects enrolled in a 3+3+3 dose escalation scheme evaluating two dose levels. In the Phase 2, approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified /gastroesophageal junction/esophageal (G/GEJ/E) adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor and subjects with MET amplified G/GEJ/E adenocarcinoma with non-measurable tumor). All subjects will self-administer AMG 337 daily until disease progression or other protocol specified end of treatment criteria are met. Tumor assessment by RECIST 1.1 will be followed during study treatment. Tumor tissue, biomarkers, pharmacokinetics and Patient Reported Outcomes will be assessed.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Amgen.