The purpose of this study is to determine a safe dose of XL844 in combination with gemcitabine, how often it should be taken, and how well people with cancer tolerate the combination of gemcitabine and XL844.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Gelatin capsules supplied as 5-mg, 25-mg, and 100-mg strengths; twice-weekly dosing.
once-weekly 30-minute IV infusion
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Safety and tolerability of XL844 as a single agent and in combination with gemcitabine when administered orally to subjects with advanced malignancies
Time frame: Assessed at each visit/periodic visits
Determine the Combination maximum tolerated dose and dose-limiting toxicities for XL844 alone and in combination with gemcitabine
Time frame: Assessed at periodic visits
Evaluate plasma pharmacokinetics and estimate renal elimination of XL844 as a single agent and in combination with gemcitabine
Time frame: Assessed at periodic visits
(Exploratory:) Assess tumor response after repeated administration of XL844 in combination with gemcitabine in subjects with advanced malignancies
Time frame: Assessed at periodic visits
Pharmacodynamic correlates of XL844 activity in tumor tissue
Time frame: Assessed at periodic visits
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