Spots Global Cancer Trial Database for Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors
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Trial Identification
Brief Title: Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors
Official Title: 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
Study ID: NCT02016534
Conditions
Interventions
Study Description
Brief 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.
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, New Haven, Connecticut, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Rochester, New York, United States
Research Site, The Bronx, New York, United States
Research Site, Cleveland, Ohio, United States
Research Site, Seattle, Washington, United States
Research Site, Camperdown, New South Wales, Australia
Research Site, Kurralta Park, South Australia, Australia
Research Site, Bentleigh East, Victoria, Australia
Research Site, Heidelberg, Victoria, Australia
Research Site, Innsbruck, , Austria
Research Site, Linz, , Austria
Research Site, Salzburg, , Austria
Research Site, Wels, , Austria
Research Site, Brussels, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Charleroi, , Belgium
Research Site, Edegem, , Belgium
Research Site, Gent, , Belgium
Research Site, Leuven, , Belgium
Research Site, Liège, , Belgium
Research Site, Edmonton, Alberta, Canada
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Hradec Kralove, , Czechia
Research Site, Olomouc, , Czechia
Research Site, Praha 2, , Czechia
Research Site, Angers, , France
Research Site, Bordeaux, , France
Research Site, Lille Cedex, , France
Research Site, Lyon cedex 8, , France
Research Site, Marseille cedex 5, , France
Research Site, Reims, , France
Research Site, Saint Herblain, , France
Research Site, Villejuif, , France
Research Site, Köln, , Germany
Research Site, Leipzig, , Germany
Research Site, Mainz, , Germany
Research Site, München, , Germany
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Heraklion - Crete, , Greece
Research Site, Ioannina, , Greece
Research Site, Piraeus, , Greece
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Kaposvar, , Hungary
Research Site, Szolnok, , Hungary
Research Site, Ancona, , Italy
Research Site, Bologna, , Italy
Research Site, Brescia, , Italy
Research Site, Cremona, , Italy
Research Site, Firenze, , Italy
Research Site, Genova, , Italy
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, Napoli, , Italy
Research Site, Parma, , Italy
Research Site, Pisa, , Italy
Research Site, Roma, , Italy
Research Site, Rozzano MI, , Italy
Research Site, Torino, , Italy
Research Site, Udine, , Italy
Research Site, Goyang-si, Gyeonggi-do, , Korea, Republic of
Research Site, Hwasun, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Bialystok, , Poland
Research Site, Elblag, , Poland
Research Site, Konin, , Poland
Research Site, Lodz, , Poland
Research Site, Warszawa, , Poland
Research Site, Krasnodar, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Malaga, Andalucía, Spain
Research Site, Sevilla, Andalucía, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Edinburgh, , United Kingdom
Research Site, Leicester, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Northwood, , United Kingdom
Research Site, Sutton, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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