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A Study of XL765 in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas


A Phase 1 Dose-Escalation Study of XL765 in Combination With Temozolomide With and Without Radiation in Subjects With Malignant Gliomas




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, TemodarĀ®) 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.

Study Status: Recruiting


Condition Intervention Phase
Mixed Gliomas
Malignant Gliomas
Glioblastoma Multiforme
Drug: XL765
Drug: Temozolomide
Phase 1

Verified by Exelixis March, 2011

Sponsored by: Exelixis
Information provided by: Exelixis identifier: NCT00704080

Study Type: Interventional

Study Design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Arthur DeCillis, MD., Study Director

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