NCT00073944

BCX-1777 in Treating Patients With Refractory Cancer

Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: BioCryst Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose of BCX-1777 in patients with refractory T-cell or non-T-cell malignancies. * Determine the safety and dose-limiting toxicity of this drug in these patients. Secondary * Determine the pharmacokinetics of single oral and single and multiple IV doses of this drug in these patients. * Determine the oral bioavailability of this drug in these patients. * Determine, preliminarily, the antitumor activity of this drug in these patients. OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. * Courses 1 and 2: Patients receive oral BCX-1777 on days 1 and 15\* and BCX-1777 IV over 30 minutes on days 8\* and 22\*. * Course 3: Beginning approximately 6 days\* after the completion of courses 1 and 2, patients receive BCX-1777 IV over 30 minutes once daily on days 1-5 and 8-12 (total of 10 doses). NOTE: \*+/- 1 day Patients with stable disease or better and no dose-limiting toxicity (DLT) may receive an additional 10-dose treatment course (as in course 3) after a 10- to 16-day drug-free interval. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BCX-1777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. Patients are followed at 14 and 30 days. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	forodesine hydrochloride

Timeline

• Start date: 2003-04-01
• Primary completion: 2005-01-01
• First posted: 2003-12-11
• Last updated: 2013-05-30

Locations

1 site across 1 country: United States