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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
dosed as capsules taken orally daily
Investigational Site Number 1526
Newport Beach, California, United States
Investigational Site Number 1532
Orlando, Florida, United States
Investigational Site Number 1239
Augusta, Georgia, United States
Investigational Site Number 1133
Boston, Massachusetts, United States
Investigational Site Number 1325
Columbus, Ohio, United States
Investigational Site Number 1434
Oklahoma City, Oklahoma, United States
Investigational Site Number 1132
Abington, Pennsylvania, United States
Investigational Site Number 1134
Philadelphia, Pennsylvania, United States
Investigational Site Number 1142
Providence, Rhode Island, United States
Investigational Site Number 1527
Dallas, Texas, United States
...and 3 more locations
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
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
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