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

Sponsor
Hoffmann-La Roche
Study ID
NCT01474239
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab [Avastin] — DRUG
    10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity
  • fotemustine — DRUG
    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

Study Details

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.

Key Dates

First listed
Nov 18, 2011
Start date
Nov 30, 2011
Status verified
Sep 2015
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
91 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Calibration Arm
  • Experimental: Investigational Arm

Primary Outcome Measure

Percentage of Participants Alive 6 Months After Start of Treatment [ Time Frame: 6 months ]

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