Status:
COMPLETED
Trial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma
Lead Sponsor:
Peking University
Collaborating Sponsors:
Novartis
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 t...
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 ...
Eligibility Criteria
Inclusion
- Histologically confirmed melanoma with metastases and has no received any systemic treatment within 1 month
- Evidence of mutations and/or copy number increases of KIT with laboratory examination documented from either primary or metastatic tumor site
- ECOG performance status 0, 1, or 2
- Estimated life expectancy of 6 months or greater
- Age 18 years or older, male of female
- At least one measurable site of disease
- Adequate organ function
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion
- Melanoma from primary sites other than acral or mucosal melanoma
- Received systemic anti-cancer therapy within 1 month before enrollment for metastatic disease
- 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
- Severe and/or uncontrolled concomitant medical diseases
- pregnant or childbreeding women
- Known hypersensitivity to imatinib
- Current treatment on another clinical trial
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00881049
Start Date
December 1 2008
End Date
January 1 2011
Last Update
January 17 2011
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Bejing, China, 10036