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.
Interventional
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)
DSMC Schedule
Yes
Tomislav Dragovich, MD, PhD
Principal Investigator
University of Arizona/Arizona Cancer Center
United States: Food and Drug Administration
PCRT04-001
NCT00226005
December 2005
February 2010
Name | Location |
---|---|
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 |