Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
A Phase I Study of XK469R (NSC 698215) in Patients With Refractory Hematologic Malignancies
Phase I trial to study the effectiveness of XK469R in treating patients who have refractory hematologic cancer. Drugs used in chemotherapy, such XK469R, work in different ways to stop cancer cells from dividing so they stop growing or die
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
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