About the AVAglio Study
AVAglio is a Phase III, randomized, double-blind, placebo controlled trial that assessed the efficacy and safety profile of Avastin in combination with radiation and temozolomide chemotherapy following surgery or biopsy in patients with newly diagnosed glioblastoma. Patients were randomized to receive either:
- Avastin plus radiation and temozolomide chemotherapy for six weeks followed by a four-week break. Patients then received Avastin and temozolomide for up to six cycles, followed by Avastin alone until disease progression.
- Radiation, temozolomide and placebo for six weeks followed by a four-week break. Patients then received temozolomide and placebo for up to six cycles, followed by placebo until disease progression.
The co-primary endpoints of the study were OS and PFS as assessed by trial investigators. Secondary endpoints included one- and two-year survival rates, PFS as assessed by an independent review committee, safety profile and quality of life measures.
About GlioblastomaGlioma (cancer of the glial cells) is the most common type of malignant primary brain tumor (a tumor that originates in the brain), accounting for approximately one-third of all cases diagnosed. Glioblastoma (or glioblastoma multiforme) is the most common and the most aggressive type of glioma, affecting approximately 10,000 people per year in the United States. Glioblastoma is a rational therapeutic target for Avastin as these tumors have among the highest levels of vascular endothelial growth factor (VEGF) of any solid tumor. About Avastin Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com. BOXED WARNINGS and Additional Important Safety Information People receiving Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:
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