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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02016534




Registration number
NCT02016534
Ethics application status
Date submitted
16/12/2013
Date registered
20/12/2013
Date last updated
2/07/2017

Titles & IDs
Public title
Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors
Scientific 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
Secondary ID [1] 0 0
2013-001277-24
Secondary ID [2] 0 0
20130111
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stomach Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 337

Experimental: Single arm - AMG 337 Monotherapy


Treatment: Drugs: AMG 337
AMG 337 300mg orally daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)
Timepoint [1] 0 0
2.5 years
Secondary outcome [1] 0 0
Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
Timepoint [1] 0 0
2.5 years
Secondary outcome [2] 0 0
Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)
Timepoint [2] 0 0
2.5 years
Secondary outcome [3] 0 0
Progression free survival
Timepoint [3] 0 0
2.5 years
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0
2.5 years
Secondary outcome [5] 0 0
Incidence and severity of adverse events and significant laboratory abnormalities
Timepoint [5] 0 0
2.5 years
Secondary outcome [6] 0 0
AMG 337 exposure and dose intensity
Timepoint [6] 0 0
2.5 years
Secondary outcome [7] 0 0
Pharmacokinetic parameters
Timepoint [7] 0 0
2.5 years
Secondary outcome [8] 0 0
Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2).
Timepoint [8] 0 0
2.5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Kurralta Park
Recruitment hospital [3] 0 0
Research Site - Bentleigh East
Recruitment hospital [4] 0 0
Research Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [3] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
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Austria
State/province [5] 0 0
Innsbruck
Country [6] 0 0
Austria
State/province [6] 0 0
Linz
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Austria
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Salzburg
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Austria
State/province [8] 0 0
Wels
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussels
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
Country [15] 0 0
Belgium
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Liège
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Canada
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Alberta
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Chile
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Santiago
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Praha 2
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France
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Angers
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France
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Bordeaux
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France
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Lille Cedex
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France
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Lyon cedex 8
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France
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Marseille cedex 5
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France
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Reims
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France
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Saint Herblain
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France
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Villejuif
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Germany
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Köln
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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München
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Greece
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Athens
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Greece
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Heraklion - Crete
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Greece
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Ioannina
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Greece
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Piraeus
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kaposvar
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Hungary
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Szolnok
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Italy
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Ancona
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Cremona
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Italy
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Firenze
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Italy
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Genova
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Italy
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Milano
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Italy
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Napoli
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Italy
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Parma
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Italy
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Pisa
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Italy
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Roma
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Italy
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Rozzano MI
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Italy
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Torino
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Italy
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Udine
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Korea, Republic of
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Goyang-si, Gyeonggi-do
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Korea, Republic of
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Hwasun
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Korea, Republic of
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Seoul
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Peru
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Lima
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Poland
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Bialystok
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Elblag
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Konin
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Lodz
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Poland
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Warszawa
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Spain
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Andalucía
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Spain
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Cataluña
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Spain
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Madrid
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United Kingdom
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Edinburgh
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United Kingdom
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Leicester
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London
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United Kingdom
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Manchester
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United Kingdom
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Northwood
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02016534
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02016534