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Terminated/Withdrawn
Sponsor ID
20130111

Phase 2 Study of AMG 337 in MET amplified Gastric/Esophageal adenocarcinoma or other solid tumors

Sponsor ID
20130111
Clinicaltrials.gov ID
NCT02016534
EUCTIS ID
N/A
EudraCT ID
2013-001277-24
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Study Details

This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.

Additional Study Details

Phase
Phase 2
Product
AMG 337
Type
Interventional
Masking
None (Open Label)
Enrollment
60
Additional Study Details

Protocol Summary

Primary Outcome Measures

Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)

Timeframe: 2.5 years

Secondary Outcome Measures

Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)

Timeframe: 2.5 years

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

Timeframe: 2.5 years

Progression free survival

Timeframe: 2.5 years

Overall survival

Timeframe: 2.5 years

Incidence and severity of adverse events and significant laboratory abnormalities

Timeframe: 2.5 years

AMG 337 exposure and dose intensity

Timeframe: 2.5 years

Pharmacokinetic parameters

Timeframe: 2.5 years

Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2).

Timeframe: 2.5 years

Study Documents

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

Locations

Location
Status
Contact Us
Location
Research Site
Kurralta Park, SA, Australia, 5037
Status
Recruiting
Location
Research Site
Leuven, Belgium, 3000
Status
Recruiting
Location
Research Site
Gent, Belgium, 9000
Status
Recruiting
Location
Research Site
Edegem, Belgium, 2650
Status
Recruiting
Location
Research Site
Bentleigh East, VIC, Australia, 3165
Status
Recruiting
Location
Research Site
Brussels, Belgium, 1000
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Gastrointestinal Cancer
    • Sex
    All
    Trial Dates
    Feb 2014 - Oct 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    -Able to daily self-administer AMG 337 orally as a whole capsule -Male or female 18 years of age or over. - Pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy -Tumor MET amplified by protocol-specified centralized testing. -Measurable disease per RECIST 1.1 guidelines. Cohort 2 may include up to 10 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
    Exclusion Criteria:
    -Known central nervous system metastases -Candidate for curative surgery or definitive chemoradiation -Peripheral edema > grade 1 -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 -Acute Hepatitis B. Chronic Hepatitis B eligible if condition is stable and, in the opinion of the investigator or Amgen physician, if consulted, would not pose a risk to subject safety -Detectable Hepatitis C virus (indicative of active Hepatitis C) -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 inclusion criteria may apply.