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A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects

Primary Purpose

Stomach Neoplasms

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

AMG 337

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring MET Amplified Gastric/ Gastroesophageal Junction/ Esophageal Adenocarcinomas, or other solid tumors

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Other protocol defined inclusion criteria may apply.

Exclusion Criteria:

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.
Other protocol defined exclusion criteria may apply.

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Outcomes

Primary Outcome Measures

Phase 1- Adverse events and clinical laboratory abnormalities

Adverse events and clinical laboratory abnormalities defined as DLTs.

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)

Secondary Outcome Measures

Phase 1- Pharmacokinetic parameters

Including, but not limited to, minimum (trough) concentrations, maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration- time curve (AUC).

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

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

Determine anti-tumor activity in AMG 337 in subjects with MET amplified solid tumors (subjects with measurable disease in cohort 2)

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

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

Phase 2- Progression Free Survival

Phase 2- Overall Survival

Phase 2- Incidence and severity of adverse events and significant laboratory abnormalities

Phase 2- AMG 337 exposure and dose intensity

Phase 2- Pharmacokinetic parameters

Including, but not limited to, minimum (trough) concentrations at pre-dose times and maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration- time curve (AUC) for intensive pharmacokinetic sampling.

Phase 1- Overall Response Rate

Phase 1- Duration of Response

Phase 1- Time to Response

Phase 1- Progression-Free Survival (per RECIST v1.1)

Phase 1- Overall Survival

Full Information

NCT ID

NCT02096666

First Posted

March 24, 2014

Last Updated

December 23, 2021

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02096666

Brief Title

A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects

Official Title

A Multicenter, Phase 1/2, Open-Label Study Evaluating the Tolerability, Safety, Pharmacokinetics, and Efficacy of AMG 337 in Asian Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

April 15, 2014 (Actual)

Primary Completion Date

November 5, 2015 (Actual)

Study Completion Date

December 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

This is a Phase 1/2, multicenter, single arm, open-label study to assess the safety, efficacy and pharmacokinetics of AMG 337 in solid tumors. In the Phase 1, approximately 3 to 45 subjects enrolled in a 3+3+3 dose escalation scheme evaluating two dose levels. In the Phase 2, approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified /gastroesophageal junction/esophageal (G/GEJ/E) adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor and subjects with MET amplified G/GEJ/E adenocarcinoma with non-measurable tumor). All subjects will self-administer AMG 337 daily until disease progression or other protocol specified end of treatment criteria are met. Tumor assessment by RECIST 1.1 will be followed during study treatment. Tumor tissue, biomarkers, pharmacokinetics and Patient Reported Outcomes will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasms

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AMG 337

Intervention Description

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)

Primary Outcome Measure Information:

Title

Phase 1- Adverse events and clinical laboratory abnormalities

Description

Adverse events and clinical laboratory abnormalities defined as DLTs.

Time Frame

17 months

Title

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

Description

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

Time Frame

17 months

Secondary Outcome Measure Information:

Title

Phase 1- Pharmacokinetic parameters

Description

Including, but not limited to, minimum (trough) concentrations, maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration- time curve (AUC).

Time Frame

17 months

Title

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

Time Frame

17 months

Title

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

Description

Determine anti-tumor activity in AMG 337 in subjects with MET amplified solid tumors (subjects with measurable disease in cohort 2)

Time Frame

17 months

Title

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

Time Frame

17 months

Title

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

Time Frame

17 months

Title

Phase 2- Progression Free Survival

Time Frame

17 months

Title

Phase 2- Overall Survival

Time Frame

17 months

Title

Phase 2- Incidence and severity of adverse events and significant laboratory abnormalities

Time Frame

17 months

Title

Phase 2- AMG 337 exposure and dose intensity

Time Frame

17 months

Title

Phase 2- Pharmacokinetic parameters

Description

Time Frame

17 months

Title

Phase 1- Overall Response Rate

Time Frame

17 months

Title

Phase 1- Duration of Response

Time Frame

17 months

Title

Phase 1- Time to Response

Time Frame

17 months

Title

Phase 1- Progression-Free Survival (per RECIST v1.1)

Time Frame

17 months

Title

Phase 1- Overall Survival

Time Frame

17 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Other protocol defined inclusion criteria may apply. Exclusion Criteria: 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. Other protocol defined exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Kashiwa-shi

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Research Site

City

Kawasaki-shi

State/Province

Kanagawa

ZIP/Postal Code

216-8511

Country

Japan

Facility Name

Research Site

City

Suntou-gun

State/Province

Shizuoka

ZIP/Postal Code

411-8777

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing URL

https://www.amgen.com/datasharing

Citations:

PubMed Identifier

28582510

Citation

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.

Results Reference

background

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects

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