Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment With Gemcitabine, Part A
This study will be conducted in three segments: Part A, Part B and Part C. Parts A and B
are 12 weeks of treatment followed by 4 weeks of evaluation. In part A patients will
dose-escalate up to three dose levels of PCI-27483 administered as subcutaneous (SC)
injections twice-daily (BID). Part B to start once 4th patient completes 90 of 112 doses in
8 weeks. In part B patients are randomized to PCI-27483 and gemcitabine (active arm) OR
gemcitabine only (control arm). PCI-27483 doses in both Part A and B will be administered in
combination with a standard regimen of gemcitabine. Patients with a tumor response or stable
disease at 12 weeks will have the opportunity to continue PCI-27483 treatment until disease
progression or the Investigator considers the study treatment to be no longer tolerable.
Treatment with gemcitabine in either the active or control arm may continue until a standard
course of gemcitabine therapy has been completed. Patients will complete Part A or Part B
after 16 weeks on study regardless of treatment duration. Evaluable patients will roll over
into part C and be followed for 12 months from enrollment (first dose).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse event profile (In Part A, dose levels will be compared to each other and in Part B the PCI-27483 arm will be compared to the control arm), from the time of the first dose till 28 days after the last dose of study treatment
First dose till 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last.
Yes
Eric Hedrick, MD
Study Director
Pharmacyclics
United States: Food and Drug Administration
PCYC-1001
NCT01020006
November 2009
December 2012
Name | Location |
---|---|
Summa Health System | Akron, Ohio 44312 |
Columbia University | New York, New York 10032-3784 |
University of Rochester | Rochester, New York 14642 |
Associates in Oncology and Hematology | Chattanooga, Tennessee 37404 |
Beth Israel Cancer Center | New York, New York 10003 |
Space Coast Medical Associates | Cocoa Beach, Florida 32931 |
Sammons Cancer Center | Dallas, Texas |
Pacific Cancer Medical Center | Anaheim, California 92801 |
Investigative Clinical Research of Indiana | Indianapolis, Indiana 46254 |
Park Nicollet Institute | St Louis Park, Minnesota 55416 |
Charleston Hematology Oncology Associates | Charleston, South Carolina 29403 |
Gabrail Cancer Center Research | Canton, Ohio 44718 |
Gettysburg Cancer Center | Gettysburg, Pennsylvania 17325 |
TGen Clinical Reserch Services at Scottsdale Healthcare | Scottsdale, Arizona 85258 |
Kenthucky Cancer Clinic | Hazard, Kentucky 41701 |
South Carolina Cancer Specialists, PA | Hilton Head, South Carolina 29926 |
University of Vermont/Vermont Cancer Center | Burlington, Vermont 05401 |