CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
bevacizumab [Avastin] +1 moredrug
Likely dose
bevacizumab [Avastin] 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01115491
NCT01115491Phase 2Completed
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A Single Arm Phase II Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme

Hoffmann-La Roche·interventional·Posted May 4, 2010·Updated Dec 8, 2014

In Brief

A Phase 2 clinical trial evaluating bevacizumab [Avastin] and temozolomide for Glioblastoma Multiforme. Completed, enrolled 32 participants across 8 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma Multiforme
CountriesSpain
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2010
Enrollment StartJun 1, 2010
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.2 years ago

Interventions

bevacizumab [Avastin]drug

Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks

temozolomidedrug

Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle