NCT01013324

Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma

A Phase 2 Study of XL147 (SAR245408) in Subjects With Advanced or Recurrent Endometrial Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There has not been any systemic therapy approved in the United States or in Europe for treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety and preliminary efficacy of XL147 in advanced or recurrent EC. Constitutively active phosphatidylinositol-3 kinase (PI3K)/phosphatase and tensin homolog on chromosome 10 (PTEN) pathway signaling is common in EC and involved in the development and/or progression of the disease. PTEN deficiency and/or activating mutations/amplification in the PIK3CA gene that encodes the p110α catalytic subunit of PI3K have been frequently detected in EC patients. XL147 is a potent and highly selective inhibitor of the Class I PI3K family of lipid kinases. In addition, in vivo preclinical data have demonstrated that XL147 targets both proximal and distal signaling in the PI3K/PTEN pathway. Therefore, XL147 may have utility in the treatment of subjects with advanced or recurrent EC.

Conditions

• Endometrial Cancer
• Endometrial Neoplasms

Interventions

Type	Name	Description
DRUG	XL147 (SAR245408)	dosed as capsules taken orally daily

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-11-13
• Last updated: 2016-06-03

Locations

13 sites across 2 countries: United States, Belgium