Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Genentech |
---|---|
Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00345163 |
This is a Phase II, open-label, multicenter, randomized, non comparative study consisting of two concurrent single-arms. Approximately 160 subjects will be randomized in a 1:1 ratio to Arm 1 (bevacizumab alone) or Arm 2 (bevacizumab + irinotecan).
Condition | Intervention | Phase |
---|---|---|
Glioblastoma |
Drug: irinotecan Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | A Phase II, Multicenter, Randomized, Non-Comparative Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme in First or Second Relapse |
Estimated Enrollment: | 167 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: bevacizumab
Intravenous repeating dose
|
2: Experimental |
Drug: irinotecan
Intravenous repeating dose
Drug: bevacizumab
Intravenous repeating dose
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Genentech, Inc. ( Isaiah Dimery, M.D., Study Director ) |
Study ID Numbers: | AVF3708g |
Study First Received: | June 23, 2006 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00345163 |
Health Authority: | United States: Food and Drug Administration |
Glioblastoma Multiforme Avastin Brain Cancer GBM |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Irinotecan Neuroepithelioma Bevacizumab Glioma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Enzyme Inhibitors Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic |