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

This study has been terminated.
(Amgen decision following interim review of efficacy and safety data from the AMG 337 program.)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02016534
First received: December 16, 2013
Last updated: November 9, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Stomach Neoplasms Drug: AMG 337 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]
    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). [ Time Frame: 2.5 years ]
    Determine antitumor activity of AMG 337 in subjects with other MET amplified solid tumors.


Other Outcome Measures:
  • Patient Reported Outcomes (PRO) Health related quality of life (HRQoL) [ Time Frame: 3 years ]
    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).

  • Tumor tissue and circulating serum biomarkers [ Time Frame: 3 years ]
    assessed at baseline. Circulating tumor cells (CTC) and circulating serum biomarkers will also be assessed at baseline and during study treatment

  • Prediction of response rates to AMG 337 by analysing tumor DNA for MET pathway-related genes [ Time Frame: 3 years ]
    To analyse tumor DNA samples for MET pathway-related genes (and other genes based on emerging data) that may predict response to AMG 337

  • Response to AMG 337 and MET amplification, expression or presence of mutation in tumor specimens [ Time Frame: 3 years ]
    Explore whether the level of MET amplification, expression, or presence of mutation in tumor specimens correlates with response to AMG 337.


Enrollment: 60
Study Start Date: February 2014
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm
AMG 337 Monotherapy
Drug: AMG 337
AMG 337 300mg orally daily.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016534

  Show 97 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02016534     History of Changes
Other Study ID Numbers: 20130111
2013-001277-24 ( EudraCT Number )
Study First Received: December 16, 2013
Last Updated: November 9, 2016

Keywords provided by Amgen:
MET Amplified Gastric / Gastroesophageal Junction / Esophageal Adenocarcinoma, or other solid tumors.

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on June 28, 2017