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

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

August 31, 2012

Conditions
Pancreatic CancerDuctal AdrenocarcinomaExocrine Pancreatic Cancer
Interventions
DRUG

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."

DRUG

Gemcitabine

Trial Locations (17)

10003

Beth Israel Cancer Center, New York

10032

Columbia University, New York

14642

University of Rochester, Rochester

17325

Gettysburg Cancer Center, Gettysburg

29414

Charleston Hematology Oncology Associates, Charleston

29926

South Carolina Cancer Specialists, PA, Hilton Head

32796

Space Coast Medical Associates, Titusville

37404

Associates in Oncology and Hematology, Chattanooga

41701

Kenthucky Cancer Clinic, Hazard

44304

Summa Health System, Akron

44718

Gabrail Cancer Center Research, Canton

46260

Investigative Clinical Research of Indiana, Indianapolis

55426

Park Nicollet Institute, Saint Louis Park

75246

Sammons Cancer Center, Dallas

85258

TGen Clinical Reserch Services at Scottsdale Healthcare, Scottsdale

92081

Pacific Cancer Medical Center, Anaheim

05401

University of Vermont/Vermont Cancer Center, Burlington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacyclics LLC.

INDUSTRY