Phase I Study of R(+)-XK469 (NSC 698215) Given Daily, Days 1-5, Repeated Every Three Weeks in Patients With Advanced Malignancies
- Determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II
dose of XK469 in patients with advanced solid tumors.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine, preliminarily, any anti-tumor activity of this drug in these patients.
- Determine the drug metabolism, drug interaction potential, molecular and cellular
predictors of efficacy and toxicity, and clinical confirmation of molecular responses
in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive XK469 IV over 20 minutes on days 1-5. Treatment repeats every 21 days for
at least 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of XK469 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of the first 6
patients experience dose-limiting toxicity.
Once the MTD is determined, up to 15 patients are treated at that dose. Patients in the
expanded MTD cohort also receive oral NovaSoy® soybean extract twice daily for the study
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 12-15
Primary Purpose: Treatment
Patricia M. LoRusso, DO
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|