NCT00028548

XK469 in Treating Patients With Advanced Solid Tumors

Phase I Study of R(+)-XK469 (NSC 698215) Given Daily, Days 1-5, Repeated Every Three Weeks in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors.

Detailed description

OBJECTIVES: * 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 duration. Patients are followed every 4 weeks. PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 12-15 months.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	R(+)XK469

Timeline

• Start date: 2002-01-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2003-01-27
• Last updated: 2014-04-25

Locations

1 site across 1 country: United States