A Phase I Surrogate Endpoint Trial of SU6668 in Patients With Incurable Solid Tumors
I. Determine the optimal biologically effective dose of SU6668 in patients with advanced
II. Assess the safety and tolerability of this therapy in these patients. III. Determine the
pharmacokinetic profile and interpatient pharmacologic variability of this therapy in these
IV. Determine the extent, frequency, and duration of any tumor responses in patients treated
with this therapy.
V. Determine a recommended phase II dose of SU6668 for future clinical studies.
OUTLINE: This is a dose-escalation study.
Patients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the
absence of unacceptable toxicity or disease progression of 100% or more.
Cohorts of at least 6 patients receive escalating doses of SU6668 until the optimal
biologically effective dose (OBD) is determined. Once the OBD is reached, dose escalation
continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of adverse events, as defined by the Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) term and body system, graded according to the National Cancer Institute Common Toxicity Criteria v2.0
Up to 2 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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