The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with paclitaxel and carboplatin in adults with solid tumors. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells. In clinical practice, the combination of paclitaxel and carboplatin is an accepted treatment regimen for various solid tumors, including ovarian cancer, endometrial cancer and non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Gelatin capsules supplied in 25- and 100-mg strengths; daily dosing
Intravenous injection dosed once every three weeks
Intravenous injection dosed once every three weeks
Investigational Site Number
St Louis, Missouri, United States
Investigational Site Number
Oklahoma City, Oklahoma, United States
Investigational Site Number
Houston, Texas, United States
Investigational Site Number
Madison, Wisconsin, United States
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 175 mg/m2) and carboplatin in subjects with advanced solid tumors
Time frame: Assessed at periodic visits
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 225 mg/m2) and carboplatin in subjects with NSCLC
Time frame: Assessed at periodic visits
To investigate the relationship between selected biomarkers and efficacy and safety outcomes
Time frame: Assessed at periodic visits
To assess plasma pharmacokinetics (PK) of XL147, paclitaxel, and carboplatin when used in combination
Time frame: Assessed at periodic visits
To evaluate preliminary antitumor activity of XL147 in combination with carboplatin and paclitaxel
Time frame: Assessed at periodic visits
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