NCT02096666

Brief Summary

This is a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal adenocarcinoma (Phase 2).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

April 15, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2015

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2018

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

1.6 years

First QC Date

March 24, 2014

Last Update Submit

December 23, 2021

Conditions

Stomach Neoplasms

Keywords

MET Amplified Gastric/ Gastroesophageal Junction/ Esophageal Adenocarcinomas, or other solid tumors

Outcome Measures

Primary Outcomes (2)

  • Phase 1- Adverse events and clinical laboratory abnormalities

    Adverse events and clinical laboratory abnormalities defined as DLTs.

    17 months

  • Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with MET amplified measurable gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)

    Determine anti-tumor activity of AMG 337 in subjects with MET amplified gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)

    17 months

Secondary Outcomes (15)

  • Phase 1- Pharmacokinetic parameters

    17 months

  • Phase 1- Other adverse events, clinical laboratory abnormalities and ECG parameters

    17 months

  • Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2)

    17 months

  • Phase 2- Duration of Response (cohort 1 and subjects with measurable disease at baseline in cohort 2)

    17 months

  • Phase 2- Time to response (cohort 1 and subjects with measurable disease at baseline in cohort 2)

    17 months

  • +10 more secondary outcomes

Study Arms (1)

Single arm

EXPERIMENTAL
Drug: AMG 337

Interventions

AMG 337DRUG

Phase 1- AMG 337 150 mg, 200mg and 300 mg orally daily. Additional 150 mg and 200 mg orally twice daily. Phase 2- AMG 337 (dose determined by Phase 1)

Single arm

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to self administer daily AMG 337 as a whole capsule
  • Male or female 20 years of age or over
  • Phase 1: Subjects must have a pathologically confirmed, advanced solid tumor for which the subjects have received prior therapy for advanced disease, for which no standard therapy exists, or the subject refuses standard therapy.
  • Phase 2: Subjects must have a pathologically confirmed, advanced G/GEJ/E adenocarcinoma (cohort 1) or other solid tumor (cohort 2) for which the subjects have received prior therapy for advanced disease, or for which no standard therapy exists, or the subject refuses standard therapy.
  • Tumor MET amplified by protocol-specified centralized testing (phase 2 only).
  • Phase 1: Measurable or non-measurable disease per RECIST v1.1
  • Phase 2: Measurable disease per RECIST v1.1 guidelines. Cohort 2 may include 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

You may not qualify if:

  • Known central nervous system metastases.
  • Subject is a candidate for curative surgery or definitive chemoradiation.
  • Peripheral edema \> grade 1.
  • Subjects who have 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Research Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Research Site

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

Research Site

Suntou-gun, Shizuoka, 411-8777, Japan

Location

Related Publications (1)

  • Yasui H, Go N, Yang H, Amore BM, Jung AS, Doi T. A Phase 1 study evaluating AMG 337 in Asian patients with advanced solid tumors. Jpn J Clin Oncol. 2017 Aug 1;47(8):772-776. doi: 10.1093/jjco/hyx067.

    PMID: 28582510BACKGROUND

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

AMG 337

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 26, 2014

Study Start

April 15, 2014

Primary Completion

November 5, 2015

Study Completion

December 7, 2018

Last Updated

December 28, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
More information

Locations

JP(4)