Esophageal Cancer Clinical Trial
Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors
Summary
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.
Full Description
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.
Eligibility 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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 96 Locations for this study
New Haven Connecticut, 06520, United States
New York New York, 10021, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
The Bronx New York, 10467, United States
Cleveland Ohio, 44106, United States
Seattle Washington, 98109, United States
Camperdown New South Wales, 2050, Australia
Kurralta Park South Australia, 5037, Australia
Bentleigh East Victoria, 3165, Australia
Heidelberg Victoria, 3084, Australia
Innsbruck , 6020, Austria
Linz , 4010, Austria
Salzburg , 5020, Austria
Wels , 4600, Austria
Brussels , 1000, Belgium
Bruxelles , 1070, Belgium
Charleroi , 6000, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Edmonton Alberta, T6G 1, Canada
Santiago , 75009, Chile
Santiago , 76303, Chile
Santiago , 84203, Chile
Hradec Kralove , 500 0, Czechia
Olomouc , 775 2, Czechia
Praha 2 , 120 0, Czechia
Angers , 49933, France
Bordeaux , 33075, France
Lille Cedex , 59020, France
Lyon cedex 8 , 69373, France
Marseille cedex 5 , 13385, France
Reims , 51092, France
Saint Herblain , 44800, France
Villejuif , 94805, France
Köln , 50937, Germany
Leipzig , 04103, Germany
Mainz , 55131, Germany
München , 81675, Germany
Athens , 11527, Greece
Athens , 11528, Greece
Athens , 14564, Greece
Heraklion - Crete , 71110, Greece
Ioannina , 45500, Greece
Piraeus , 18537, Greece
Budapest , 1097, Hungary
Debrecen , 4032, Hungary
Kaposvar , 7400, Hungary
Szolnok , 5004, Hungary
Ancona , 60126, Italy
Bologna , 40138, Italy
Brescia , 25123, Italy
Cremona , 26100, Italy
Firenze , 50134, Italy
Genova , 16132, Italy
Milano , 20133, Italy
Milano , 20162, Italy
Napoli , 80131, Italy
Parma , 43126, Italy
Pisa , 56126, Italy
Roma , 00189, Italy
Rozzano MI , 20089, Italy
Torino , 10126, Italy
Udine , 33100, Italy
Goyang-si, Gyeonggi-do , 410-7, Korea, Republic of
Hwasun , 519-7, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 137-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Lima , Lima , Peru
Lima , Lima , Peru
Bialystok , 15-02, Poland
Elblag , 82-30, Poland
Konin , 62-50, Poland
Lodz , 93-51, Poland
Warszawa , 02-78, Poland
Krasnodar , 35004, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 11999, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Malaga AndalucÃa, 29010, Spain
Sevilla AndalucÃa, 41013, Spain
Barcelona Cataluña, 08035, Spain
Barcelona Cataluña, 08036, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Edinburgh , EH4 2, United Kingdom
Leicester , LE1 5, United Kingdom
London , SE1 7, United Kingdom
Manchester , M20 4, United Kingdom
Northwood , HA6 2, United Kingdom
Sutton , SM2 5, United Kingdom
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.