Spots Global Cancer Trial Database for XK469R in Treating Patients With Refractory Hematologic Cancer

Study Description

Brief Summary: 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

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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