A Phase I Study of Oblimersen (Genasense™, G3139) in Combination With Gemcitabine in Advanced Malignancies
I. Determine the maximum tolerated dose and dose-limiting toxicity of oblimersen and
gemcitabine in patients with advanced solid tumor or lymphoma.
II. Determine the effect of oblimersen on the pharmacokinetics and pharmacodynamics of
gemcitabine in these patients.
III. Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oblimersen IV continuously on days 1-5 and gemcitabine IV over 2-3 hours on
day 5. Courses repeat every 2 weeks in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of oblimersen 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. Up to 10 additional
patients receive treatment at the MTD.
PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study within 6-8
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose level at which less than 2 out of 6 patients experience DLT assessed using NCI CTC version 2.0
Descriptive statistics will be employed in the analysis of all safety and laboratory observations.
Branimir (Brandy) Sikic
United States: Food and Drug Administration
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