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Bevacizumab, Irinotecan, and Carboplatin for Recurrent Malignant Glioma
NCT00953121Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2009
- Primary completion
- Jul 2012
- Countries
- 1
- Sponsor
- Istari Oncology
- Modality
- Monoclonal Antibodies, DNA Intercalators/Alkylators
- Conditions
- malignant glioma
01
Overview
Phase 2, open-label trial of bevacizumab, irinotecan and carboplatin in malignant glioma (3 cohorts), sponsored by Istari Oncology. Primary endpoint: 6 Month Progression-free Survival. Started Sep 2009; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Cohort A-Grade IV No Failure
Recurrent GBM, no prior Bev/Iri/Carbo failure.
Cohort B-Grade III No Failure
Recurrent Grade 3 glioma, no prior Bev/Iri/Carbo failure.
Cohort C-Failed Prior Therapy
Recurrent GBM, failed prior Bev, no prior Iri/Carbo failure.
03
Who it enrols
Patients must have recurrent malignant glioma (GBM or Grade 3) with no more than 3 prior episodes of progression. Cohort C requires prior failure on bevacizumab, while Cohorts A and B exclude patients with prior failure or significant toxicity to bevacizumab, irinotecan, or carboplatin. Adequate hematologic, renal, and hepatic function is required.
04
Endpoints
Primary
6 Month Progression-free Survival
Secondary
Objective Response Rate
Median Progression Free Survival
Median Overall Survival
Safety of Bevacizumab in Combination With Irinotecan and Carboplatin
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