Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer
This is an open-label, phase II trial of PTK787/ZK 222584. Patients will receive 750 mg
daily for one week, 1000 mg daily for the second week, and then 1250 mg per day thereafter.
Response Assessment: In the absence of toxicity or clinical progression, patients will
remain in the study until their PSA has doubled from pretreatment baseline.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the efficacy of PTK787/ZK 222584 in terms of prostate-specific antigen (PSA) response, in patients with hormone-refractory prostate cancer
Kathleen W. Beekman, MD
The University of Michigan Comprehensive Cancer Center
United States: Food and Drug Administration