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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02016534
Other study ID # 20130111
Secondary ID 2013-001277-24
Status Terminated
Phase Phase 2
First received December 16, 2013
Last updated June 28, 2017
Start date February 2014
Est. completion date October 2016

Study information

Verified date June 2017
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AMG 337
AMG 337 300mg orally daily.

Locations

Country Name City State
Australia Research Site Bentleigh East Victoria
Australia Research Site Camperdown New South Wales
Australia Research Site Heidelberg Victoria
Australia Research Site Kurralta Park South Australia
Austria Research Site Innsbruck
Austria Research Site Linz
Austria Research Site Salzburg
Austria Research Site Wels
Belgium 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
Canada Research Site Edmonton Alberta
Chile Research Site Santiago
Chile Research Site Santiago
Chile Research Site Santiago
Czechia Research Site Hradec Kralove
Czechia Research Site Olomouc
Czechia Research Site Praha 2
France 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
Germany Research Site Köln
Germany Research Site Leipzig
Germany Research Site Mainz
Germany Research Site München
Greece Research Site Athens
Greece Research Site Athens
Greece Research Site Athens
Greece Research Site Heraklion - Crete
Greece Research Site Ioannina
Greece Research Site Piraeus
Hungary Research Site Budapest
Hungary Research Site Debrecen
Hungary Research Site Kaposvar
Hungary Research Site Szolnok
Italy 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
Korea, Republic of 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
Peru Research Site Lima
Peru Research Site Lima
Poland Research Site Bialystok
Poland Research Site Elblag
Poland Research Site Konin
Poland Research Site Lodz
Poland Research Site Warszawa
Russian Federation Research Site Krasnodar
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Saint-Petersburg
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 Malaga Andalucía
Spain Research Site Sevilla Andalucía
United Kingdom 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 States Research Site Cleveland Ohio
United States 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 Seattle Washington
United States Research Site The Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Chile,  Czechia,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Peru,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient Reported Outcomes (PRO) Health related quality of life (HRQoL) 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). 3 years
Other Tumor tissue and circulating serum biomarkers assessed at baseline. Circulating tumor cells (CTC) and circulating serum biomarkers will also be assessed at baseline and during study treatment 3 years
Other Prediction of response rates to AMG 337 by analysing tumor DNA for MET pathway-related genes To analyse tumor DNA samples for MET pathway-related genes (and other genes based on emerging data) that may predict response to AMG 337 3 years
Other Response to AMG 337 and MET amplification, expression or presence of mutation in tumor specimens Explore whether the level of MET amplification, expression, or presence of mutation in tumor specimens correlates with response to AMG 337. 3 years
Primary 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 Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2) 2.5 years
Secondary Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2) 2.5 years
Secondary Progression free survival 2.5 years
Secondary Overall survival 2.5 years
Secondary Incidence and severity of adverse events and significant laboratory abnormalities 2.5 years
Secondary AMG 337 exposure and dose intensity 2.5 years
Secondary 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). 2.5 years
Secondary 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. 2.5 years
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