Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
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.