A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

October 31, 2013

Study Completion Date

February 28, 2015

Conditions
Pancreatic Cancer
Interventions
DRUG

Simtuzumab

Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle

DRUG

Placebo to match simtuzumab

Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Trial Locations (57)

10003

Saint Luke's-Roosevelt Hospital Center, New York

17109

PinnacleHealth, Harrisburg

19090

Abington Hematology Oncology Associates, Inc., Willow Grove

30341

Georgia Cancer Specialists, P.C., Atlanta

33607

Florida Cancer Specialists, Tampa

36604

University of South Alabama Mitchell Cancer Institute, Mobile

37206

Tennessee Oncology, PLLC, Nashville

41017

Oncology Hematology Care, Inc., Crestview Hills

45242

Oncology Hematology Care, Inc., Blue Ash

48075

Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland, Southfield

63108

Washington University School of Medicine, St Louis

78234

San Antonio Military Medical Center, Fort Sam Houston

84106

Utah Cancer Specialists, Salt Lake City

91730

Wilshire Oncology Medical Group, Inc., Rancho Cucamonga

92123

Sharp Health Care, San Diego

93720

California Cancer Associates for Research and Excellence (CCARE), Fresno

95116

San Jose Medical Group, San Jose

115478

Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology, Moscow

"State Institution Blokhin Cancer Research Centre RAMS", Moscow

125367

"Non-State Institution of healthcare Central Clinical Hospital #1 OAO RZD", Moscow

129128

"Non-state Healthcare Institution N.A. Semashko Central Clinical Hospital #2 of JSC Russian Railway", Moscow

153040

Regional Oncology Dispensary, Ivanovo

163045

"State Institution of Healthcare Arkhangelsk Regional Clinical Oncology Dispensary", Arkhangelsk

197758

Petrov Research Oncology Institute, Saint Petersburg

249036

Medical Radiological Research Center of Russian Academy of Medical Sciences, Obninsk, Obninsk

305035

Kursk Regional Oncologic Dispensary, Kursk

420029

Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan, Kazan'

450054

Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan, Ufa

603081

"State Budgetary Healthcare Institution Nizhny Novgorod Regional Oncological Dispensary", Nizhny Novgorod

644013

"Budgetary Healthcare Institution of Omsk Region Clinical Oncologic Dispensary", Omsk

Unknown

Birmingham Hematology and Oncology Associates, LLC, Birmingham

Central Hematology Oncology Medical Group, Inc., Alhambra

Comprehensive Blood and Cancer Center, Bakersfield

Anne Arundel Medical Center, Annapolis Oncology Center, Annapolis

West Michigan Cancer Center, Kalamazoo

Pacific Shores Medical Group, Long Beach

UCLA Community Oncology Practice, Los Angeles

Stanford University Medical Center, Palo Alto

Saint Mary's Regional Cancer Center, Grand Junction

Hematology Oncology Associates, PC, Stamford

Northwestern University, Chicago

Hematology and Oncology Associates at BridgePoint, Tupelo

Saint Joseph Oncology, Inc., Saint Joseph

Montana Cancer Institute Foundation c/o Montana Cancer Specialists, Missoula

Comprehensive Cancer Centers of Nevada, Henderson

Beth Israel Comprehensive Cancer Center, New York

Duke University Medical Center, Comprehensive Cancer Center, Durham

Emerywood Hematology and Oncology, High Point

Charleston Hematology Oncology Associates, PA, Charleston

South Carolina Oncology Associates, Columbia

Tennessee Cancer Specialists, Knoxville

Coastal Bend Cancer Center, Corpus Christi

University of Texas Southwestern Medical Center at Dallas, Dallas

Center for Cancer and Blood Disorders, PC, Fort Worth

Joe Arrington Cancer Research and Treatment Center, Lubbock

Virginia Cancer Specialists, PC, Fairfax

Virginia Cancer Institute, Richmond

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY