A Phase 1 Study of PXD101 in Combination With Bortezomib (PS-341) in Patients With Advanced Solid Tumors and Lymphoma
I. Evaluate the safety profile and determine the maximum tolerated dose of PXD101 in
combination with bortezomib in patients with advanced solid tumors or lymphomas.
II. Determine the pharmacokinetics of the combination of PXD101 and bortezomib in these
III. Evaluate selected biomarkers of drug effect in these patients. IV. Evaluate the
activity of this regimen, in terms of objective response rate, in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive PXD101 IV over 30 minutes on days 1-5 and bortezomib IV on days 1, 4, 8,
and 11 (2, 5, 8, and 11 during course 1). Treatment repeats every 21 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-9 patients receive escalating doses of bortezomib and PXD101 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose-limiting toxicity. Blood is collected at baseline and
periodically during course 1 of study treatment for pharmacokinetic studies.
After completion of study treatment, patients are followed periodically for 4 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of PXD101 in combination with bortezomib
Defined as the dose level below that which results in drug-related dose limiting toxicity (DLT) in >= 2 of 6 new patients.
University of Colorado, Denver
United States: Food and Drug Administration
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