Stomach NeoplasmsPhase 2NCT02016534

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

A Phase 2 study testing AMG 337 in people with Stomach Neoplasms, run by Amgen at 97 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stomach Neoplasms
What is being tested?: AMG 337
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 97 sitesin 18 countries
Study dates: Feb 2014to Oct 2016
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 9Show fewer

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.

Trial locations and contacts

97 sites in 18 countries.

Country

City, postcode or hospital

97 sites in 18 countries

Italy15 sites

Research Site
Ancona, 60126
Research Site
Bologna, 40138
Research Site
Brescia, 25123
Research Site
Cremona, 26100
Research Site
Florence, 50134
Research Site
Genova, 16132
Research Site
Milan, 20133
Research Site
Milan, 20162
Research Site
Naples, 80131
Research Site
Parma, 43126
Research Site
Pisa, 56126
Research Site
Roma, 00189
Research Site
Rozzano MI, 20089
Research Site
Torino, 10126
Research Site
Udine, 33100

Other trials in Italy

France8 sites

Research Site
Angers, 49933
Research Site
Bordeaux, 33075
Research Site
Lille, 59020
Research Site
Lyon, 69373
Research Site
Marseille, 13385
Research Site
Reims, 51092
Research Site
Saint-Herblain, 44800
Research Site
Villejuif, 94805

Other trials in France

United States7 sites

Research Site
Cleveland, Ohio, 44106
Research Site
New Haven, Connecticut, 06520
Research Site
New York, New York, 10021
Research Site
New York, New York, 10065
Research Site
Rochester, New York, 14642
Research Site
Seattle, Washington, 98109
Research Site
The Bronx, New York, 10467

Other trials in United States

Belgium7 sites

Research Site
Brussels, 1000
Research Site
Brussels, 1070
Research Site
Charleroi, 6000
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Liège, 4000

Other trials in Belgium

South Korea7 sites

Research Site
Goyang-si, Gyeonggi-do, 410-769
Research Site
Hwasun, 519-763
Research Site
Seoul, 110-744
Research Site
Seoul, 120-752
Research Site
Seoul, 135-710
Research Site
Seoul, 137-701
Research Site
Seoul, 138-736

Other trials in South Korea

Spain7 sites

Research Site
Barcelona, Catalonia, 08035
Research Site
Barcelona, Catalonia, 08036
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Málaga, Andalusia, 29010
Research Site
Seville, Andalusia, 41013

Other trials in Spain

Greece6 sites

Research Site
Athens, 11527
Research Site
Athens, 11528
Research Site
Athens, 14564
Research Site
Heraklion - Crete, 71110
Research Site
Ioannina, 45500
Research Site
Piraeus, 18537

Other trials in Greece

United Kingdom6 sites

Research Site
Edinburgh, EH4 2XU
Research Site
Leicester, LE1 5WW
Research Site
London, SE1 7EH
Research Site
Manchester, M20 4BX
Research Site
Northwood, HA6 2RN
Research Site
Sutton, SM2 5PT

Other trials in United Kingdom

Poland5 sites

Research Site
Bialystok, 15-027
Research Site
Elblag, 82-300
Research Site
Konin, 62-500
Research Site
Lodz, 93-513
Research Site
Warsaw, 02-781

Other trials in Poland

Australia4 sites

Research Site
Bentleigh East, Victoria, 3165
Research Site
Camperdown, New South Wales, 2050
Research Site
Heidelberg, Victoria, 3084
Research Site
Kurralta Park, South Australia, 5037

Other trials in Australia

Austria4 sites

Research Site
Innsbruck, 6020
Research Site
Linz, 4010
Research Site
Salzburg, 5020
Research Site
Wels, 4600

Other trials in Austria

Germany4 sites

Research Site
Cologne, 50937
Research Site
Leipzig, 04103
Research Site
Mainz, 55131
Research Site
München, 81675

Other trials in Germany

Hungary4 sites

Research Site
Budapest, 1097
Research Site
Debrecen, 4032
Research Site
Kaposvár, 7400
Research Site
Szolnok, 5004

Other trials in Hungary

Russia4 sites

Research Site
Krasnodar, 350040
Research Site
Moscow, 115478
Research Site
Moscow, 119991
Research Site
Saint Petersburg, 197758

Other trials in Russia

Chile3 sites

Research Site
Santiago, 7500921
Research Site
Santiago, 7630370
Research Site
Santiago, 8420383

Other trials in Chile

Czechia3 sites

Research Site
Hradec Králové, 500 05
Research Site
Olomouc, 775 20
Research Site
Prague, 120 00

Other trials in Czechia

Peru2 sites

Research Site
Lima, Lima 11
Research Site
Lima, Lima 18

Other trials in Peru

Canada1 site

Research Site
Edmonton, Alberta, T6G 1Z2

Other trials in Canada

About this study

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

Read the 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.

Conditions: Stomach Neoplasms
Being tested: AMG 337
Keywords: MET Amplified Gastric / Gastroesophageal Junction / Esophageal Adenocarcinoma, or other solid tumors.
Medical subject headings: Stomach Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMG 337Drug
AMG 337 300mg orally daily.

Study groups in NCT02016534
Study group	Role	What they receive
Single arm	Experimental	AMG 337 Monotherapy Receives: Drug: AMG 337

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2.5 years

Secondary outcomes (8)

Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
Measured: 2.5 years
Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)
Measured: 2.5 years
Progression free survival
Measured: 2.5 years
Overall survival
Measured: 2.5 years
Incidence and severity of adverse events and significant laboratory abnormalities
Measured: 2.5 years
AMG 337 exposure and dose intensity
Measured: 2.5 years
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).
Measured: 2.5 years
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.
Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Oct 2016

First posted20 Dec 2013 (estimated)
Study startFeb 2014
Primary completionOct 2016
Study completionOct 2016

Why it stopped: Amgen decision following interim review of efficacy and safety data from the AMG 337 program.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02016534
Sponsor's protocol ID: 20130111
Other IDs: 2013-001277-24
Status last verified: Jun 2017
First submitted: 16 Dec 2013
Last updated: 2 Jul 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stomach Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02016534
Acronym / sponsor ID: 20130111
Conditions: Stomach Neoplasms
Keywords: MET Amplified Gastric / Gastroesophageal Junction / Esophageal Adenocarcinoma, or other solid tumors.
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Amgen decision following interim review of efficacy and safety data from the AMG 337 program.
Enrolment: 60 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 20 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Tumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be assessed.

Tumor assessment by RECIST 1.1 will be followed during study treatment.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single arm	Experimental	Drug: AMG 337AMG 337 Monotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMG 337AMG 337 300mg orally daily.	Drug	Single arm

Primary outcome

Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)
Time frame: 2.5 years
Determine antitumor activity of AMG 337 in subjects with MET amplified G/GEJ/E adenocarcinoma

8 secondary outcomes

Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
Time frame: 2.5 years
Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)
Time frame: 2.5 years
Progression free survival
Time frame: 2.5 years
Overall survival
Time frame: 2.5 years
Incidence and severity of adverse events and significant laboratory abnormalities
Time frame: 2.5 years
AMG 337 exposure and dose intensity
Time frame: 2.5 years
Pharmacokinetic parameters
Time frame: 2.5 years
Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2).
Time frame: 2.5 years

Results and safety

The study was stopped early (reason given: Amgen decision following interim review of efficacy and safety data from the AMG 337 program.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Stomach Neoplasms

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

97 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 337 in people with Stomach Neoplasms, run by Amgen at 97 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in Italy, France, United States, Belgium, South Korea and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Amgen decision following interim review of efficacy and safety data from the AMG 337 program.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1) (time frame: 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02016534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.