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Brief Title: Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
Official Title: Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
Study ID: NCT01020006
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of selected dose 1.2mg/kg BID dosage administered subcutaneously (SC) administered PCI-27483 to metastatic or locally advanced pancreatic cancer patients receiving concurrent therapy with intravenously administered gemcitabine for 12 weeks.
Detailed Description: 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
TGen Clinical Reserch Services at Scottsdale Healthcare, Scottsdale, Arizona, United States
Pacific Cancer Medical Center, Anaheim, California, United States
Space Coast Medical Associates, Titusville, Florida, United States
Investigative Clinical Research of Indiana, Indianapolis, Indiana, United States
Kenthucky Cancer Clinic, Hazard, Kentucky, United States
Park Nicollet Institute, St. Louis Park, Minnesota, United States
Beth Israel Cancer Center, New York, New York, United States
Columbia University, New York, New York, United States
University of Rochester, Rochester, New York, United States
Summa Health System, Akron, Ohio, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Gettysburg Cancer Center, Gettysburg, Pennsylvania, United States
Charleston Hematology Oncology Associates, Charleston, South Carolina, United States
South Carolina Cancer Specialists, PA, Hilton Head, South Carolina, United States
Associates in Oncology and Hematology, Chattanooga, Tennessee, United States
Sammons Cancer Center, Dallas, Texas, United States
University of Vermont/Vermont Cancer Center, Burlington, Vermont, United States
Name: Eric Hedrick, MD
Affiliation: Pharmacyclics LLC.
Role: STUDY_DIRECTOR
Name: Laurence Elias, MD
Affiliation: Pharmacyclics LLC.
Role: STUDY_DIRECTOR