A Phase I Pharmacokinetics and Pharmacodynamic Study of GTI2040 in Combination With Gemcitabine in Patients With Solid Tumors
OBJECTIVES: Primary I. Determine the toxicity profile and maximum tolerated dose of GTI-2040
and gemcitabine in patients with metastatic or unresectable solid tumors.
Secondary I. Determine the pharmacokinetics and pharmacodynamics of this regimen in these
OUTLINE: This is an open-label, dose-escalation study.
Patients receive GTI-2040 IV continuously on days 2-16 of course 1 and on days 1-16 of all
subsequent courses and gemcitabine IV over 30 minutes on days 1, 8, and 15 of course 1 and
on days 2, 9, and 16 of all subsequent courses. Courses repeat every 28 days in the absence
of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of GTI-2040 and gemcitabine until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
determined, 10 additional patients are treated at that dose.
PROJECTED ACCRUAL: Approximately 18-40 patients will be accrued for this study within 6-20
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of GTI-2040 and gemcitabine hydrochloride, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0
Up to day 28
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
United States: Food and Drug Administration
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