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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Collaborator: Novartis
• Treatments: Imatinib Mesylate

Criteria

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