The purpose of this study is to determine the best and safest dose of XL184 administered orally. XL184 is a new chemical entity that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration. To determine the highest safe dose, subjects will receive different amounts of the drug. The first group of subjects will receive the lowest dose of XL184. As long as no medically unacceptable side effects are noted, the dose will be increased for the next group. When the maximum tolerated dose (MTD) is reached, at least 20 subjects with Medullary Thyroid Cancer (MTC) will be enrolled to evaluate the effect of XL184 in this population.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Flavored liquid suspension or gelatin capsules supplied in 25-mg and 100-mg strengths; daily dosing or intermittent schedule (daily dosing followed by dosing holiday in cycles)
University of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Univ. of Texas MD Anderson Cancer Center
Houston, Texas, United States
Safety, tolerability, maximum tolerated dose (MTD), and dose-limiting toxicity of oral administration of XL184
Time frame: Assessed during periodic visits
Evaluate plasma pharmacokinetics and estimate renal elimination of oral administration of XL184
Time frame: Assessed during periodic visits
Long-term safety/tolerability of XL184 after oral administration for up to 1 year
Time frame: Assessed during periodic visits
Evaluate preliminary tumor response after repeated XL184 administration
Time frame: Assessed during periodic visits
In MTD expanded cohort: Progression-free survival and duration of response in subjects with advanced or recurrent medullary thyroid cancer
Time frame: Assessed during periodic visits
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