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Trial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma

Sponsor
Peking University (Other)
Overall Status
Completed
CT.gov ID
NCT00881049
Collaborator
Novartis (Industry)
1
Enrollment
1
Location
25
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a single-armed, open-label, single-center phase II trial of signal transduction inhibitor number 571 (STI-571) systemic therapy in selective patients with metastatic melanoma, and aims to study the efficacy and safety. The primary endpoint is progression-free survival (PFS) and the second endpoints are overall response rate (ORR), overall survival (OS), 1-year OS and safety.

Condition or Disease Intervention/Treatment Phase
  • Drug: Imatinib (Gleevec)
 Phase 2

Detailed Description

Only patients who meet the inclusion and exclusion criteria will be enrolled. The estimated recruitment duration is 1 year. Imatinib will be given in the dose of 400 mg orally each day unless disease progression or intolerance. The follow-up is 12 months.

Forty-eight subjects will be recruited for this study. This sample size is justified by the number of patients required to establish an improvement in PFS with statistical significance compared to historical control.

The standardized RECIST (Response Evaluation Criteria in Solid Tumors) method of unidimensional tumor assessment will be employed to evaluate tumor lesion size per 2 months in the determination of response rate and progression free survival. Repeated radiographic assessment at 4 week intervals is consistent with general oncological practice associated with computerized tomography (CT) or magnetic resonance imaging (MRI) scan testing. All efficacy endpoints will be evaluated by the investigator.

Safety will be characterized in terms of the incidence, timing, severity, and relatedness of adverse events and laboratory abnormalities. Severity will be graded according to the NCI CTCAE Version 3.0.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of Imatinib(Gleevec®) in Selected Patients With Metastatic Melanoma
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologically confirmed melanoma with metastases and has no received any systemic treatment within 1 month

    2. Evidence of mutations and/or copy number increases of KIT with laboratory examination documented from either primary or metastatic tumor site

    3. ECOG performance status 0, 1, or 2

    4. Estimated life expectancy of 6 months or greater

    5. Age 18 years or older, male of female

    6. At least one measurable site of disease

    7. Adequate organ function

    8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

    Exclusion Criteria:

    1. Melanoma from primary sites other than acral or mucosal melanoma

    2. Received systemic anti-cancer therapy within 1 month before enrollment for metastatic disease

    3. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer

    4. Severe and/or uncontrolled concomitant medical diseases

    5. pregnant or childbreeding women

    6. Known hypersensitivity to imatinib

    7. Current treatment on another clinical trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Cancer Hospital Beijing Bejing China 10036

    Sponsors and Collaborators

    • Peking University
    • Novartis

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00881049
    Other Study ID Numbers:
    • CSTI571BCN19T
    First Posted:
    Apr 14, 2009
    Last Update Posted:
    Jan 17, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    metastatic acral or mucosal melanoma with c-kit mutation or copy number increase
    Additional relevant MeSH terms:
    Melanoma
    Imatinib Mesylate

    Study Results

    No Results Posted as of Jan 17, 2011