NCT00756847

Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Combination With Paclitaxel and Carboplatin in Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with paclitaxel and carboplatin in adults with solid tumors. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells. In clinical practice, the combination of paclitaxel and carboplatin is an accepted treatment regimen for various solid tumors, including ovarian cancer, endometrial cancer and non-small cell lung cancer (NSCLC).

Conditions

• Cancer
• Non-Small Cell Lung Cancer
• Endometrial Carcinoma
• Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	XL147 (SAR245408),	Gelatin capsules supplied in 25- and 100-mg strengths; daily dosing
DRUG	paclitaxel	Intravenous injection dosed once every three weeks
DRUG	carboplatin	Intravenous injection dosed once every three weeks

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-05-01
• Completion: 2012-10-01
• First posted: 2008-09-22
• Last updated: 2013-04-10

Locations

4 sites across 1 country: United States