Phase II Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.
This is an open-label, phase II multi-center therapeutic trial investigating the efficacy
and tolerability of PTK787/ZK222584 in patients with metastatic or advanced pancreatic
cancer who failed first line gemcitabine-based therapy. The primary objective of this study
is to evaluate the 6-month survival rate, time to progression, and tolerability of the
regimen in pancreatic cancer patients treated with PTK787/ZK222584 as second-line therapy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives. Safety Issue: the only endpoint/outcome measure that was a safety issue was the second one (safety and tolerability of PTK)
Tomislav Dragovich, MD, PhD
University of Arizona/Arizona Cancer Center
United States: Food and Drug Administration
|South Texas Oncology and Hematology||San Antonio, Texas 78229|
|Tower Hematology Oncology Medical Group||Los Angeles, California 90048|
|Scottsdale Healthcare||Scottsdale, Arizona 85251|
|Sarah Cannon Research Institute||Nashville, Tennessee 37203|
|University of Arizona/Arizona Cancer Center||Tucson, Arizona 85724|
|Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins||Baltimore, Maryland 21231|
|Virginia Piper Cancer Institute/Abbott Northwestern Hospital||Minneapolis, Minnesota 55407|