An Open Label, Non Randomized , One Sequence, Add-On Study to Investigate the Effects of PTK787/ZK 222584 on the Pharmacokinetics and Pharmacodynamics of Warfarin at Steady-States in Cancer Patients
- Determine the acute and chronic changes in INR in patients with advanced solid tumors
treated with low-dose warfarin and vatalanib.
- Determine the steady-state pharmacokinetics of this regimen in these patients.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
- Pharmacokinetic (PK) phase: Patients receive oral low-dose warfarin once daily on days
1-14 and oral vatalanib once daily, 1 hour before warfarin administration, on days 2-14
in the absence of disease progression or unacceptable toxicity.
- Continuation phase: Patients not experiencing a drug interaction in the PK phase
continue to receive oral vatalanib and oral low-dose warfarin once daily. Patients
experiencing a drug interaction (INR > 2.0) in the PK phase receive oral vatalanib
alone once daily. Continuation therapy continues indefinitely in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate acute and chronic changes in INR when Warfarin is co-administered with PTK787/ZK 222584
Joel R. Hecht, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|