42
Participants
Start Date
November 30, 2009
Primary Completion Date
August 31, 2012
PCI-27483
"Part A: Closed to enrollment.Part B: Approximately 20 patients will be randomized to the control arm that will receive a standard regimen of gemcitabine and 20 patients will be randomized to the PCI-27483 arm and treated with both gemcitabine and PCI-27483. PCI-27483 will be administered as subcutaneous (SC) injections, nominally at a dosage of 1.2 mg/kg BID. Patients receiving PCI-27483 with a tumor response or stable disease at 12 weeks will have the option to continue PCI-27483 treatment until disease progression or the investigator considers the study treatment no longer tolerable. Treatment with gemcitabine may continue per standard of care.~All evaluable patients will roll over into Part C at week 16 (Day 113±5). If 2 consecutive INRs at 2 hours postdose are \>3.50,a reduced dosage will be calculated."
Gemcitabine
Beth Israel Cancer Center, New York
Columbia University, New York
University of Rochester, Rochester
Gettysburg Cancer Center, Gettysburg
Charleston Hematology Oncology Associates, Charleston
South Carolina Cancer Specialists, PA, Hilton Head
Space Coast Medical Associates, Titusville
Associates in Oncology and Hematology, Chattanooga
Kenthucky Cancer Clinic, Hazard
Summa Health System, Akron
Gabrail Cancer Center Research, Canton
Investigative Clinical Research of Indiana, Indianapolis
Park Nicollet Institute, Saint Louis Park
Sammons Cancer Center, Dallas
TGen Clinical Reserch Services at Scottsdale Healthcare, Scottsdale
Pacific Cancer Medical Center, Anaheim
University of Vermont/Vermont Cancer Center, Burlington
Lead Sponsor
Pharmacyclics LLC.
INDUSTRY