The purpose of this study is to assess the safety and tolerability of the multi-targeted protein kinase inhibitor XL228 (active against IGF1R, Src, FGFR, and BCR-Abl) administered as a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
1-hour IV infusion
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
To assess the safety and tolerability of XL228 administered as a once-weekly or twice-weekly 1-hour intravenous (IV) infusion in subjects with advanced malignancies.
Time frame: Assessed at periodic visits
To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies.
Time frame: Assessed at periodic visits
To evaluate plasma pharmacokinetics of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies.
Time frame: Assessed at periodic visits
To evaluate preliminary safety and efficacy of XL228 when administered at the once-weekly MTD
Time frame: Assessed at periodic visits
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