Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/14/2016
Start Date:February 2014
End Date:January 2017

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A Multicenter, Phase 2, Single Arm, Two Cohort Study Evaluating the Efficacy, Safety, and Pharmacokinetics of AMG337 in Subjects With MET Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma or Other MET Amplified Solid Tumors

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.

This is a phase 2, multicenter, single arm, 2 cohort study to assess the safety, efficacy
and pharmacokinetics of AMG 337 in MET amplified Gastric/esophageal adenocarcinoma or other
solid tumors. Approximately 140 subjects will be enrolled to either Cohort 1 (subjects with
MET amplified G/E adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET
amplified solid tumors with measurable tumor/up to 10 subjects with MET amplified G/E
adenocarcinoma with non-measurable tumor/up to 10 subjects who have received prior MET
antibody therapy). All subjects will self-administer AMG 337 300 mg daily until disease
progression or other protocol specified end of treatment criteria is met.

Tumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be
assessed.

Tumor assessment by RECIST 1.1 will be followed during study treatment.

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.
We found this trial at
8
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