A Phase 1 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Gemcitabine in Patients With Epithelial Tumors
I. Determine the dose-limiting toxicity, maximum tolerated dose, and pharmacokinetics of
vorinostat (SAHA) and gemcitabine in patients with metastatic or unresectable epithelial
II. Determine tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation, open-label study.
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and gemcitabine IV over 1-2
hours on days 3 and 10. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SAHA 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. A minimum of 6 patients are
treated at the MTD.
After completion of study treatment, patients are followed for 30 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximally tolerated dose of a combination of SAHA and gemcitabine determined by dose-limiting toxicity as measured by NCI CTCAE v3.0 continuously
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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