Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine



Status:Archived
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:November 2009
End Date:December 2012

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Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment With Gemcitabine, Part A


The purpose of this study is to evaluate the safety and tolerability of subcutaneously (SC)
administered PCI-27483 at pharmacologically active doses during repeated, ascending dose
administration to metastatic or locally advanced pancreatic cancer patients receiving
concurrent therapy with intravenously administered gemcitabine for 12 weeks. Secondly to
establish a dosage for evaluation in the Part B portion of this study.


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).


We found this trial at
15
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Gettysburg, Pennsylvania 17325
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Akron, Ohio 44304
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Anaheim, California 92801
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Anaheim, CA
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Boston, Massachusetts 02215
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Boston, MA
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Burlington, VT
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Canton, OH
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Chattanooga, Tennessee 37404
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Chattanooga, TN
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Dallas, TX
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Hazard, Kentucky 41701
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Hazard, KY
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Knoxville, Tennessee 37920
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Knoxville, TN
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Minneapolis, Minnesota 55426
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Minneapolis, MN
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722 W 168th St
New York, New York 10032
(212) 305-2500
Columbia Presbyterian Med Ctr On January 1, 1998, The New York Hospital publicly announced its...
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New York, NY
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Richardson, Texas 75080
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Richardson, TX
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601 Elmwood Ave
Rochester, New York 14642
(585) 275-2100
Strong Memorial Hospital (University of Rochester School of Medicine) In addition to offering traditional and...
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Rochester, NY
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Scottsdale, Arizona 85258
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Scottsdale, AZ
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