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Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors

Primary Purpose

Advanced Gastrointestinal Stromal Tumor

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 706
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastrointestinal Stromal Tumor focused on measuring Gastrointestinal Stromal Tumor, Imatinib Mesylate Resistance, Phase2 study, AMG 706

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of histological confirmed GIST Had prior imatinib mesylate therapy Has at least 1 measurable leasion by modified RECIST Exclusion Criteria: Central nervous system tumor involvement requiring treatment History of myocardial infraction Uncontrolled hypertension

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm One

    Arm Description

    AMG 706 125mg, oral, once a day

    Outcomes

    Primary Outcome Measures

    The objective response rate as assessed by modified RECIST

    Secondary Outcome Measures

    Duration of response, progression-free survival, time to response, overall survival, PK and safety profile

    Full Information

    First Posted
    November 14, 2005
    Last Updated
    February 26, 2014
    Sponsor
    Amgen
    Collaborators
    Takeda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00254267
    Brief Title
    Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors
    Official Title
    An Open-label Phase 2 Study of AMG 706 in Japanese Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen
    Collaborators
    Takeda

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Gastrointestinal Stromal Tumor
    Keywords
    Gastrointestinal Stromal Tumor, Imatinib Mesylate Resistance, Phase2 study, AMG 706

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm One
    Arm Type
    Experimental
    Arm Description
    AMG 706 125mg, oral, once a day
    Intervention Type
    Drug
    Intervention Name(s)
    AMG 706
    Intervention Description
    AMG 706 125mg, oral, once a day
    Primary Outcome Measure Information:
    Title
    The objective response rate as assessed by modified RECIST
    Time Frame
    Every 8 weeks
    Secondary Outcome Measure Information:
    Title
    Duration of response, progression-free survival, time to response, overall survival, PK and safety profile
    Time Frame
    imaging, every 8 weeks; survival, every 6 months; PK, Days 1,15, 29, 43, 57, every 2 weeks in week 9 to 16, and every 4 weeks thereafter;

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of histological confirmed GIST Had prior imatinib mesylate therapy Has at least 1 measurable leasion by modified RECIST Exclusion Criteria: Central nervous system tumor involvement requiring treatment History of myocardial infraction Uncontrolled hypertension
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20838998
    Citation
    Benjamin RS, Schoffski P, Hartmann JT, Van Oosterom A, Bui BN, Duyster J, Schuetze S, Blay JY, Reichardt P, Rosen LS, Skubitz K, McCoy S, Sun YN, Stepan DE, Baker L. Efficacy and safety of motesanib, an oral inhibitor of VEGF, PDGF, and Kit receptors, in patients with imatinib-resistant gastrointestinal stromal tumors. Cancer Chemother Pharmacol. 2011 Jul;68(1):69-77. doi: 10.1007/s00280-010-1431-9. Epub 2010 Sep 14.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

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    Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors

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