Back to resultsPhase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors
Primary Purpose
Stomach Neoplasms
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AMG 337
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring MET Amplified Gastric / Gastroesophageal Junction / Esophageal Adenocarcinoma, or other solid tumors.
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
AMG 337 Monotherapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)
Progression free survival
Overall survival
Incidence and severity of adverse events and significant laboratory abnormalities
AMG 337 exposure and dose intensity
Pharmacokinetic parameters
Including, but not limited to, minimum (trough) concentrations at pre-dose times, maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration - time curve (AUC).
Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2).
Determine antitumor activity of AMG 337 in subjects with other MET amplified solid tumors.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02016534
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 Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Amgen decision following interim review of efficacy and safety data from the AMG 337 program.
Study Start Date
February 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
MET Amplified Gastric / Gastroesophageal Junction / Esophageal Adenocarcinoma, or other solid tumors.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
AMG 337 Monotherapy
Intervention Type
Drug
Intervention Name(s)
AMG 337
Intervention Description
AMG 337 300mg orally daily.
Primary Outcome Measure Information:
Title
Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)
Description
Determine antitumor activity of AMG 337 in subjects with MET amplified G/GEJ/E adenocarcinoma
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
Time Frame
2.5 years
Title
Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)
Time Frame
2.5 years
Title
Progression free survival
Time Frame
2.5 years
Title
Overall survival
Time Frame
2.5 years
Title
Incidence and severity of adverse events and significant laboratory abnormalities
Time Frame
2.5 years
Title
AMG 337 exposure and dose intensity
Time Frame
2.5 years
Title
Pharmacokinetic parameters
Description
Including, but not limited to, minimum (trough) concentrations at pre-dose times, maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration - time curve (AUC).
Time Frame
2.5 years
Title
Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2).
Description
Determine antitumor activity of AMG 337 in subjects with other MET amplified solid tumors.
Time Frame
2.5 years
Other Pre-specified Outcome Measures:
Title
Patient Reported Outcomes (PRO) Health related quality of life (HRQoL)
Description
To evaluate the impact of AMG 337 on health-related quality of life (HRQoL) in subjects with MET amplified G/GEJ/E adenocarcinoma (Cohort 1 only).
Time Frame
3 years
Title
Tumor tissue and circulating serum biomarkers
Description
assessed at baseline. Circulating tumor cells (CTC) and circulating serum biomarkers will also be assessed at baseline and during study treatment
Time Frame
3 years
Title
Prediction of response rates to AMG 337 by analysing tumor DNA for MET pathway-related genes
Description
To analyse tumor DNA samples for MET pathway-related genes (and other genes based on emerging data) that may predict response to AMG 337
Time Frame
3 years
Title
Response to AMG 337 and MET amplification, expression or presence of mutation in tumor specimens
Description
Explore whether the level of MET amplification, expression, or presence of mutation in tumor specimens correlates with response to AMG 337.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Research Site
City
The Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Research Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Research Site
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Research Site
City
Bentleigh East
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Research Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Research Site
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Research Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7630370
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Research Site
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Research Site
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Research Site
City
Lyon cedex 8
ZIP/Postal Code
69373
Country
France
Facility Name
Research Site
City
Marseille cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Research Site
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Research Site
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Research Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Research Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
14564
Country
Greece
Facility Name
Research Site
City
Heraklion - Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
Research Site
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Research Site
City
Piraeus
ZIP/Postal Code
18537
Country
Greece
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Research Site
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Research Site
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Research Site
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Research Site
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Research Site
City
Rozzano MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Research Site
City
Goyang-si, Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Research Site
City
Hwasun
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 11
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 18
Country
Peru
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Research Site
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Research Site
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Malaga
State/Province
Andalucía
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Research Site
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors
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