The purpose of this study is to evaluate the safety and tolerability of XL888 in subjects with solid tumors. XL888 is a potent and selective inhibitor of HSP90, a key component of a molecular chaperone complex that promotes the conformational maturation and stabilization of diverse client proteins. Many HSP90 client proteins play critical roles in signaling pathways implicated in tumor cell growth, proliferation, and survival.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Administered orally
Hospital of the University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Safety, tolerability, and maximum tolerated dose of oral administration of XL888 when administered on an intermittent schedule to adults with solid tumors
Time frame: Assessed at several visits during weeks 1 through 4 of the first cycle and approximately every other week each cycle thereafter
Plasma pharmacokinetics of oral administration of XL888 when administered on an intermittent schedule
Time frame: Assessed at several visits during weeks 1 through 4 of the first cycle and approximately once every four weeks each cycle thereafter
Pharmacodynamic effects of XL888 on both tumor tissue and non-tumor tissue
Time frame: Assessed at specific visits during the first cycle; mandatory blood samples collected once every four weeks every cycle thereafter with optional tissue samples
Estimate renal elimination of XL888
Time frame: Assessed during the first cycle after three weeks of dosing
Exploratory: To evaluate preliminary antitumor activity of XL888
Time frame: Assessed every eight weeks
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