A Phase I, Pharmacologic and Biologic Study of Col-3 (NSC683551) Administered on a 28-Day Oral Dosing Schedule in Patients With Advanced Solid Tumors
OBJECTIVES: I. Define the maximum tolerated dose of COL-3 in patients with advanced solid
tumors. II. Identify the dose limiting toxicity and safety profile of COL-3 in these
patients. III. Define the pharmacokinetics and pharmacodynamics of COL-3 in these patients.
IV. Observe any evidence of antitumor activity through standard response criteria or
biologic surrogate markers.
OUTLINE: This is a dose escalation study. Patients receive oral COL-3 once daily. Treatment
continues in the absence of disease progression and unacceptable toxic effects. Cohorts of
3-6 patients each receive escalating doses of COL-3. Dose escalation to the next level
occurs after 3 patients have completed 28 days of treatment without dose limiting toxicity
(DLT). Dose escalation continues until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose preceding that at which 2 or more of 6 patients experience DLT.
PROJECTED ACCRUAL: Up to 30 patients will be accrued within 1 year for this study.
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Eric K. Rowinsky, MD
San Antonio Cancer Institute
United States: Food and Drug Administration
|San Antonio Cancer Institute||San Antonio, Texas 78229-3264|