A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme

Sponsor
Hoffmann-La Roche
Study ID
NCT01115491
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks
  • temozolomide — DRUG
    Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle

Study Details

This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.

Key Dates

First listed
May 4, 2010
Start date
Jun 30, 2010
Status verified
Dec 2014
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: A

Primary Outcome Measure

Progression-Free Survival (PFS) - Percentage of Participants With an Event [ Time Frame: Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks ]

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