Clinical trial · Interventional
Trial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma
Phase II Trial of Imatinib(Gleevec®) in Selected Patients With Metastatic Melanoma
NCT00881049CI-TRIAL-00004290completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib (Gleevec) | Drug | Imatinib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.