Back to Search Results
Study Complete
Sponsor ID
20120370

A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects

Sponsor ID
20120370
Clinicaltrials.gov ID
NCT02096666
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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).

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 337
Type
Interventional
Masking
None (Open Label)
Enrollment
11
Additional Study Details

Protocol Summary

Primary Outcome Measures

Phase 1- Adverse events and clinical laboratory abnormalities

Timeframe: 17 months

Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with MET amplified measurable gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)

Timeframe: 17 months

Secondary Outcome Measures

Phase 1- Pharmacokinetic parameters

Timeframe: 17 months

Phase 1- Other adverse events, clinical laboratory abnormalities and ECG parameters

Timeframe: 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)

Timeframe: 17 months

Phase 2- Duration of Response (cohort 1 and subjects with measurable disease at baseline in cohort 2)

Timeframe: 17 months

Phase 2- Time to response (cohort 1 and subjects with measurable disease at baseline in cohort 2)

Timeframe: 17 months

Phase 2- Progression Free Survival

Timeframe: 17 months

Phase 2- Overall Survival

Timeframe: 17 months

Phase 2- Incidence and severity of adverse events and significant laboratory abnormalities

Timeframe: 17 months

Phase 2- AMG 337 exposure and dose intensity

Timeframe: 17 months

Phase 2- Pharmacokinetic parameters

Timeframe: 17 months

Phase 1- Overall Response Rate

Timeframe: 17 months

Phase 1- Duration of Response

Timeframe: 17 months

Phase 1- Time to Response

Timeframe: 17 months

Phase 1- Progression-Free Survival (per RECIST v1.1)

Timeframe: 17 months

Phase 1- Overall Survival

Timeframe: 17 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Suntou-gun, Shizuoka, Japan, 411-8777
Status
Recruiting
Location
Research Site
Kashiwa-shi, Chiba, Japan, 277-8577
Status
Recruiting
Location
Research Site
Kawasaki-shi, Kanagawa, Japan, 216-8511
Status
Recruiting
Location
Research Site
Sapporo-shi, Hokkaido, Japan, 060-8648
Status
Recruiting
Study Info
Age
20+ years
Condition
  • Gastrointestinal Cancer
    • Sex
    All
    Trial Dates
    Apr 2014 - Nov 2015
    Inclusion and Exclusion 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.