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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02096666
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

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).

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Drug: AMG 337 Phase 1 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase 1/2, Open-Label Study Evaluating the Tolerability, Safety, Pharmacokinetics, and Efficacy of AMG 337 in Asian Subjects
Actual Study Start Date : April 15, 2014
Actual Primary Completion Date : November 5, 2015
Actual Study Completion Date : December 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm Drug: AMG 337
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 Measures :
  1. Phase 1- Adverse events and clinical laboratory abnormalities [ Time Frame: 17 months ]
    Adverse events and clinical laboratory abnormalities defined as DLTs.

  2. Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with MET amplified measurable gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1) [ Time Frame: 17 months ]
    Determine anti-tumor activity of AMG 337 in subjects with MET amplified gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)


Secondary Outcome Measures :
  1. Phase 1- Pharmacokinetic parameters [ Time Frame: 17 months ]
    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).

  2. Phase 1- Other adverse events, clinical laboratory abnormalities and ECG parameters [ Time Frame: 17 months ]
  3. Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2) [ Time Frame: 17 months ]
    Determine anti-tumor activity in AMG 337 in subjects with MET amplified solid tumors (subjects with measurable disease in cohort 2)

  4. Phase 2- Duration of Response (cohort 1 and subjects with measurable disease at baseline in cohort 2) [ Time Frame: 17 months ]
  5. Phase 2- Time to response (cohort 1 and subjects with measurable disease at baseline in cohort 2) [ Time Frame: 17 months ]
  6. Phase 2- Progression Free Survival [ Time Frame: 17 months ]
  7. Phase 2- Overall Survival [ Time Frame: 17 months ]
  8. Phase 2- Incidence and severity of adverse events and significant laboratory abnormalities [ Time Frame: 17 months ]
  9. Phase 2- AMG 337 exposure and dose intensity [ Time Frame: 17 months ]
  10. Phase 2- Pharmacokinetic parameters [ Time Frame: 17 months ]
    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.

  11. Phase 1- Overall Response Rate [ Time Frame: 17 months ]
  12. Phase 1- Duration of Response [ Time Frame: 17 months ]
  13. Phase 1- Time to Response [ Time Frame: 17 months ]
  14. Phase 1- Progression-Free Survival (per RECIST v1.1) [ Time Frame: 17 months ]
  15. Phase 1- Overall Survival [ Time Frame: 17 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096666


Locations
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Japan
Research Site
Kashiwa-shi, Chiba, Japan, 277-8577
Research Site
Sapporo-shi, Hokkaido, Japan, 060-8648
Research Site
Kawasaki-shi, Kanagawa, Japan, 216-8511
Research Site
Suntou-gun, Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
Publications:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02096666    
Other Study ID Numbers: 20120370
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: December 28, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://www.amgen.com/datasharing
Keywords provided by Amgen:
MET Amplified Gastric/ Gastroesophageal Junction/ Esophageal Adenocarcinomas, or other solid tumors
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases