Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies
- Determine the maximum tolerated dose of BCX-1777 in patients with refractory T-cell or
- Determine the safety and dose-limiting toxicity of this drug in these patients.
- 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
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
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.
Masking: Open Label, Primary Purpose: Treatment
Alex Shalaurov, MD, PhD
Inveresk Research Group, Incorporated
United States: Federal Government
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|