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

Phase 2
18 Years
85 Years
Not Enrolling
Metastatic Melanoma

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Trial Information

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

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.

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


China: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

January 2011

Related Keywords:

  • Metastatic Melanoma
  • metastatic acral or mucosal melanoma with c-kit mutation or copy number increase
  • Melanoma