NCT01240460

Exploratory Study of XL765 (SAR245409) or XL147 (SAR245408) in Subjects With Recurrent Glioblastoma Who Are Candidates for Surgical Resection

An Exploratory Pharmacodynamic Study of XL765 and XL147 Administered as Single Agents to Subjects With Recurrent Glioblastoma Who Are Candidates for Surgical Resection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure what effect the study drug XL765 (SAR245409) or the study drug XL147 (SAR245408) has on tumor tissue in subjects with recurrent glioblastoma (GB) who are candidates for surgical resection. XL765 (SAR245409) and XL147 (SAR245408), the two investigational agents examined in this study, XL147 (SAR245408) is a potent inhibitor of PI3 Kinase (PI3K) and XL765 (SAR245409) is a dual PI3K and mTOR inhibitor. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.

Conditions

• Glioblastoma
• Astrocytoma, Grade IV

Interventions

Type	Name	Description
DRUG	XL765 (SAR245409)	Supplied as 10-mg and/or 50-mg capsules
DRUG	XL147 (SAR245408)	Supplied as 100-mg, 150-mg and/or 200-mg tablets

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-11-15
• Last updated: 2012-07-27

Locations

4 sites across 1 country: United States