Clinical Trial: Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2 Study of XL147 (SAR245408) in Subjects With Advanced or Recurrent Endometrial Carcinoma
Brief 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.
Detailed Summary:
Sponsor: Sanofi
Current Primary Outcome:
- Efficacy as defined by overall response rate and progression-free survival (PFS) at 6 months [ Time Frame: every 8-10 weeks ]
- Safety of XL147 in the EC population [ Time Frame: scheduled evaluations every 2-4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of response and PFS [ Time Frame: every 8-10 weeks ]
- Characterize pharmacokinetic and pharmacodynamic profiles of XL147 [ Time Frame: at periodic visits not less than every 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: November 10, 2009
Date Started: January 2010
Date Completion:
Last Updated: May 9, 2016
Last Verified: May 2016
