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

NCT02016534 | Terminated Phase 2

• 2 other identifiers: 201301112013-001277-24
• Study Type: interventional
• Target: 60
• Locations: 17 countries
• Sites: 93

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.

Conditions

Stomach Neoplasms

Keywords

MET Amplified Gastric / Gastroesophageal Junction / Esophageal Adenocarcinoma, or other solid tumors.

Outcome Measures

Primary Outcomes (1)

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

  Determine antitumor activity of AMG 337 in subjects with MET amplified G/GEJ/E adenocarcinoma

  2.5 years

Secondary Outcomes (8)

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

  2.5 years

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

  2.5 years

• Progression free survival

  2.5 years

• Overall survival

  2.5 years

• Incidence and severity of adverse events and significant laboratory abnormalities

  2.5 years

Other Outcomes (4)

• Patient Reported Outcomes (PRO) Health related quality of life (HRQoL)

  3 years

• Tumor tissue and circulating serum biomarkers

  3 years

• Prediction of response rates to AMG 337 by analysing tumor DNA for MET pathway-related genes

  3 years

Study Arms (1)

Single arm

EXPERIMENTAL

AMG 337 Monotherapy

Drug: AMG 337

Interventions

AMG 337 DRUG

AMG 337 300mg orally daily.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (97)

Research Site

New Haven, Connecticut, 06520, United States

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New York, New York, 10021, United States

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New York, New York, 10065, United States

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Rochester, New York, 14642, United States

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The Bronx, New York, 10467, United States

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Cleveland, Ohio, 44106, United States

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Seattle, Washington, 98109, United States

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Camperdown, New South Wales, 2050, Australia

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Kurralta Park, South Australia, 5037, Australia

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Bentleigh East, Victoria, 3165, Australia

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Heidelberg, Victoria, 3084, Australia

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Innsbruck, 6020, Austria

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Linz, 4010, Austria

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Salzburg, 5020, Austria

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Wels, 4600, Austria

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Brussels, 1000, Belgium

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Brussels, 1070, Belgium

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Charleroi, 6000, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Edmonton, Alberta, T6G 1Z2, Canada

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Santiago, 7500921, Chile

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Santiago, 7630370, Chile

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Santiago, 8420383, Chile

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Hradec Králové, 500 05, Czechia

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Olomouc, 775 20, Czechia

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Prague, 120 00, Czechia

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Angers, 49933, France

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Bordeaux, 33075, France

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Lille, 59020, France

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Lyon, 69373, France

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Marseille, 13385, France

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Reims, 51092, France

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Saint-Herblain, 44800, France

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Villejuif, 94805, France

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Cologne, 50937, Germany

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Leipzig, 04103, Germany

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Mainz, 55131, Germany

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München, 81675, Germany

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Athens, 11527, Greece

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Athens, 11528, Greece

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Athens, 14564, Greece

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Heraklion - Crete, 71110, Greece

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Ioannina, 45500, Greece

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Piraeus, 18537, Greece

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Budapest, 1097, Hungary

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Debrecen, 4032, Hungary

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Kaposvár, 7400, Hungary

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Szolnok, 5004, Hungary

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Ancona, 60126, Italy

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Bologna, 40138, Italy

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Brescia, 25123, Italy

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Cremona, 26100, Italy

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Florence, 50134, Italy

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Genova, 16132, Italy

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Milan, 20133, Italy

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Milan, 20162, Italy

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Napoli, 80131, Italy

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Parma, 43126, Italy

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Pisa, 56126, Italy

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Roma, 00189, Italy

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Rozzano MI, 20089, Italy

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Torino, 10126, Italy

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Udine, 33100, Italy

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Lima, Lima 11, Peru

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Lima, Lima 18, Peru

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Bialystok, 15-027, Poland

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Elblag, 82-300, Poland

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Konin, 62-500, Poland

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Lodz, 93-513, Poland

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Warsaw, 02-781, Poland

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Krasnodar, 350040, Russia

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Moscow, 115478, Russia

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Moscow, 119991, Russia

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Saint Petersburg, 197758, Russia

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Goyang-si, Gyeonggi-do, 410-769, South Korea

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Hwasun, 519-763, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 137-701, South Korea

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Seoul, 138-736, South Korea

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Málaga, Andalusia, 29010, Spain

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Seville, Andalusia, 41013, Spain

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Barcelona, Catalonia, 08035, Spain

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Barcelona, Catalonia, 08036, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Edinburgh, EH4 2XU, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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London, SE1 7EH, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Northwood, HA6 2RN, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma Of Esophagus

Interventions

AMG 337

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: February 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

US (7); KR (7); DE (4); HU (4); ES (7); FR (8); GB (6); PL (5); IT (15); AU (4); GR (6); BE (7); RU (4); PE (2); CZ (3); CA (1); CL (3)