CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Avastin +1 moredrug
Likely dose
Avastin 15 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/NCT00611325
NCT00611325Phase 2Completed
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Phase II Trial of Avastin Plus Bortezomib for Patients With Recurrent Malignant Glioma

Duke University·interventional·Posted Feb 8, 2008·Updated Mar 12, 2014

In Brief

A Phase 2 clinical trial evaluating Avastin and Bortezomib for Glioblastoma and Gliosarcoma. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Primary Objective To estimate 6-month progression free survival probability of patients with recurrent glioblastoma multiforme treated with bortezomib plus Avastin. This efficacy assessment will be made separately among patients on enzyme-inducing anti-epileptic drugs and non enzyme-inducing anti-epileptic drugs. Secondary Objectives To evaluate safety \& tolerability of bortezomib plus Avastin among patients with recurrent malignant glioma. To evaluate radiographic response, progression free survival \& overall survival of patients with recurrent malignant glioma treated with bortezomib plus Avastin

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma, Gliosarcoma
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc., Genentech, Inc.

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2008
Enrollment StartMay 1, 2008
Primary CompletionSep 1, 2009
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.4 years ago

Interventions

Avastindrug

Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.

Bortezomibdrug

Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, \& 32 of a 42-day cycle. Bortezomib was 1.7 mg/m2 for patients not taking EIAEDs \& 2.5 mg/m2 for patients taking EIAEDs.