Clinical trial NCT02016534: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: MET Amplified Gastric / Gastroesophageal Junction / Esophageal Adenocarcinoma, or other solid tumors.
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)
timeFrame: 2.5 years
Secondary outcomes:
measure: Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
timeFrame: 2.5 years
measure: Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)
timeFrame: 2.5 years
measure: Progression free survival
timeFrame: 2.5 years
measure: Overall survival
timeFrame: 2.5 years
measure: Incidence and severity of adverse events and significant laboratory abnormalities
timeFrame: 2.5 years
measure: AMG 337 exposure and dose intensity
timeFrame: 2.5 years
measure: Pharmacokinetic parameters
timeFrame: 2.5 years
measure: Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2).
timeFrame: 2.5 years
Other outcomes:
measure: Patient Reported Outcomes (PRO) Health related quality of life (HRQoL)
timeFrame: 3 years
measure: Tumor tissue and circulating serum biomarkers
timeFrame: 3 years
measure: Prediction of response rates to AMG 337 by analysing tumor DNA for MET pathway-related genes
timeFrame: 3 years
measure: Response to AMG 337 and MET amplification, expression or presence of mutation in tumor specimens
timeFrame: 3 years
Locations:
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: New York
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: The Bronx
country: United States
facility: Research Site
state: New York
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Camperdown
country: Australia
facility: Research Site
state: New South Wales
city: Kurralta Park
country: Australia
facility: Research Site
state: South Australia
city: Bentleigh East
country: Australia
facility: Research Site
state: Victoria
city: Heidelberg
country: Australia
facility: Research Site
state: Victoria
city: Innsbruck
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Lyon cedex 8
country: France
facility: Research Site
city: Marseille cedex 5
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Saint Herblain
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Heraklion - Crete
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Kaposvar
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Cremona
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rozzano MI
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Hwasun
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Konin
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
state: Andalucía
city: Sevilla
country: Spain
facility: Research Site
state: Andalucía
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Sutton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: