A Phase 2 Study of XL147 in Subjects With Advanced or Recurrent Endometrial Cancer

Status
Active
Cancer Type
Endometrial Cancer
Trial Phase
Phase II
Eligibility
18 and over, Female
Study Type
Treatment
NCD ID
NCT01013324
Protocol IDs
XL147-201 (primary)
Study Sponsor
Exelixis, Incorporated

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 p110a 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.

Treatment Sites in Georgia


Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

Study Coordinator:
Pam Bourbo
706-721-7230

Doctors:

Sharad A. Ghamande MD
Michael S. MacFee MD