At a glance
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An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating bevacizumab [Avastin] and fotemustine for Malignant Melanoma. Completed, enrolled 20 participants across 4 sites.
Detailed Summary
This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously\[IV\]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Study Details
Timeline
Interventions
15 mg/kg intravenously on day 1 of every 3 week cycle
100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles