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This study examines the oral drug RAF265 in people with locally advanced or metastatic melanoma (a type of skin cancer). It enrolled patients with confirmed melanoma between AJCC stage IIIB and stage IV who had measurable disease. The research was conducted in Phase 1/Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Confirmed diagnosis of melanoma, locally advanced AJCC Stage IIIB to metastatic Stage IV 2. Measurable disease - at least one lesion measured in at least one dimension as ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan 3. ECOG performance status of 0 or 1 4. No concurrent anticancer or investigational therapy for at least 4 weeks prior to enrollment 5. No major surgery for at least 4 weeks prior to enrollment Exclusion Criteria: 1. Significant cardiac disease or other significant medical/psychiatric disease 2. History of primary central nervous system tumor or brain metastases 3. History of melena, hematemesis, or hemoptysis within the last 3 months 4. Previous therapy with certain molecularly targeted agents