A Phase I Study of XK469R (NSC 698215) in Patients With Refractory Hematologic Malignancies
I. Determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II
dose of XK469R in patients with refractory hematologic malignancies.
II. Determine the pharmacokinetics of this drug in these patients.
I. Determine the presence of genetic variations potentially affecting XK469R disposition in
patients treated with this drug.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive XK469R IV over 30-60 minutes on days 1, 3, and 5. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of XK469R until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients
experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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