NCT01069627

A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	bevacizumab [Avastin]	15 mg/kg intravenously on day 1 of every 3 week cycle
DRUG	fotemustine	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

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2010-02-17
• Last updated: 2018-12-06
• Results posted: 2014-06-25

Locations

4 sites across 1 country: Italy