NCT01474239

A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma

Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	bevacizumab [Avastin]	10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity
DRUG	fotemustine	75 mg/m2 intravenously on days 1, 8 and 15 followed by, after a 5 weeks interval, 100 mg/m2 on day 1 of a 3-weeks cycle. Until disease progression or unacceptable toxicity

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-11-18
• Last updated: 2016-03-15
• Results posted: 2015-08-07

Locations

10 sites across 1 country: Italy