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

Stomach Neoplasms Clinical Trial

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

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
• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Stomach Neoplasms

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

External Links

•   AmgenTrials clinical trials website