Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors
NCT ID: NCT02016534
Last Updated: 2017-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
60 participants
INTERVENTIONAL
2014-02-28
2016-10-31
Brief Summary
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Detailed Description
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Tumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be assessed.
Tumor assessment by RECIST 1.1 will be followed during study treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
AMG 337 Monotherapy
AMG 337
AMG 337 300mg orally daily.
Interventions
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AMG 337
AMG 337 300mg orally daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Edinburgh, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Northwood, , United Kingdom
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Sutton, , United Kingdom
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Edmonton, Alberta, Canada
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Angers, , France
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Bordeaux, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Reims, , France
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Saint-Herblain, , France
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Villejuif, , France
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Cologne, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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München, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Heraklion - Crete, , Greece
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Ioannina, , Greece
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Piraeus, , Greece
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Budapest, , Hungary
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Debrecen, , Hungary
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Kaposvár, , Hungary
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Szolnok, , Hungary
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Ancona, , Italy
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Bologna, , Italy
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Brescia, , Italy
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Cremona, , Italy
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Florence, , Italy
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Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Parma, , Italy
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Pisa, , Italy
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Roma, , Italy
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Rozzano MI, , Italy
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Torino, , Italy
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Udine, , Italy
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Lima, , Peru
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Lima, , Peru
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Bialystok, , Poland
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Elblag, , Poland
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Konin, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Krasnodar, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Goyang-si, Gyeonggi-do, , South Korea
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Hwasun, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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New Haven, Connecticut, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Cleveland, Ohio, United States
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Seattle, Washington, United States
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Camperdown, New South Wales, Australia
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Kurralta Park, South Australia, Australia
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Bentleigh East, Victoria, Australia
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Heidelberg, Victoria, Australia
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Innsbruck, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Wels, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
Research Site
Liège, , Belgium
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-001277-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20130111
Identifier Type: -
Identifier Source: org_study_id
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