Study:
A Phase 1 Dose-Escalation Study of XL765 in Combination With Temozolomide With and Without Radiation in Subjects With Malignant Gliomas
Rationale:
n/a
Purpose:
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.
Study Status: Recruiting
Recruiting:
n/a
| 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
ClinicalTrials.gov 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