A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the safety and tolerability of XL765 in combination
with Temozolomide in adults with anaplastic gliomas or glioblastoma on a stable Temozolomide
maintenance dose. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In
preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce
apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown
to inhibit the growth of tumor cells. Temozolomide (TMZ, Temodar®) is an orally administered
alkylating agent with activity against malignant gliomas. It is approved by the Food and Drug
Administration for the following indications: 1) treatment of newly diagnosed glioblastoma
multiforme (GBM) patients when given concomitantly with radiotherapy and then as maintenance
treatment; 2) refractory anaplastic astrocytoma (AA), ie, patients who have experienced
disease progression on a drug regimen containing nitrosourea and procarbazine. Temozolomide
is commonly used in the treatment of other anaplastic gliomas (AG) including oligodendroglial
tumors and mixed gliomas.