search
Back to results

Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)

Primary Purpose

Gastrointestinal Stromal Tumors

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Imatinib Mesylate
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring GIST, Imatinib, STI571, Gastrointestinal Stromal Tumors

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Patients who completed the CSTI571B1201 study Exclusion Criteria: - Other protocol-defined inclusion / exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Imatinib Mesylate

    Arm Description

    400 mg once daily

    Outcomes

    Primary Outcome Measures

    To study the antineoplastic effect of the investigational drug.

    Secondary Outcome Measures

    To study the safety and pharmacokinetics of the investigational drug.

    Full Information

    First Posted
    October 9, 2005
    Last Updated
    April 29, 2012
    Sponsor
    Novartis Pharmaceuticals
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00237172
    Brief Title
    Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)
    Official Title
    Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    July 2005 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    This is a extension study of CSTI571B1201 study

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Stromal Tumors
    Keywords
    GIST, Imatinib, STI571, Gastrointestinal Stromal Tumors

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Imatinib Mesylate
    Arm Type
    Experimental
    Arm Description
    400 mg once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Imatinib Mesylate
    Other Intervention Name(s)
    STI571
    Intervention Description
    once daily
    Primary Outcome Measure Information:
    Title
    To study the antineoplastic effect of the investigational drug.
    Secondary Outcome Measure Information:
    Title
    To study the safety and pharmacokinetics of the investigational drug.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Patients who completed the CSTI571B1201 study Exclusion Criteria: - Other protocol-defined inclusion / exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)

    We'll reach out to this number within 24 hrs