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Brief Title: A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma
Official Title: A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma
Study ID: NCT01472198
Brief Summary: This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Birmingham Hematology and Oncology Associates, LLC, Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
Central Hematology Oncology Medical Group, Inc., Alhambra, California, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
California Cancer Associates for Research and Excellence (CCARE), Fresno, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
UCLA Community Oncology Practice, Los Angeles, California, United States
Stanford University Medical Center, Palo Alto, California, United States
Wilshire Oncology Medical Group, Inc., Rancho Cucamonga, California, United States
Sharp Health Care, San Diego, California, United States
San Jose Medical Group, San Jose, California, United States
Saint Mary's Regional Cancer Center, Grand Junction, Colorado, United States
Hematology Oncology Associates, PC, Stamford, Connecticut, United States
Florida Cancer Specialists, Tampa, Florida, United States
Georgia Cancer Specialists, P.C., Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Oncology Hematology Care, Inc., Crestview Hills, Kentucky, United States
Anne Arundel Medical Center, Annapolis Oncology Center, Annapolis, Maryland, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland, Southfield, Michigan, United States
Hematology and Oncology Associates at BridgePoint, Tupelo, Mississippi, United States
Saint Joseph Oncology, Inc., Saint Joseph, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Montana Cancer Institute Foundation c/o Montana Cancer Specialists, Missoula, Montana, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Saint Luke's-Roosevelt Hospital Center, New York, New York, United States
Beth Israel Comprehensive Cancer Center, New York, New York, United States
Duke University Medical Center, Comprehensive Cancer Center, Durham, North Carolina, United States
Emerywood Hematology and Oncology, High Point, North Carolina, United States
Oncology Hematology Care, Inc., Blue Ash, Ohio, United States
PinnacleHealth, Harrisburg, Pennsylvania, United States
Abington Hematology Oncology Associates, Inc., Willow Grove, Pennsylvania, United States
Charleston Hematology Oncology Associates, PA, Charleston, South Carolina, United States
South Carolina Oncology Associates, Columbia, South Carolina, United States
Tennessee Cancer Specialists, Knoxville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Coastal Bend Cancer Center, Corpus Christi, Texas, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States
San Antonio Military Medical Center, Fort Sam Houston, Texas, United States
Center for Cancer and Blood Disorders, PC, Fort Worth, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan, Ufa, Bashkortostan, Russian Federation
Medical Radiological Research Center of Russian Academy of Medical Sciences, Obninsk, Obninsk, Kaluga, Russian Federation
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary", Arkhangelsk, Primorskiy, Russian Federation
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan, Kazan, Tatarstan, Russian Federation
Regional Oncology Dispensary, Ivanovo, , Russian Federation
Kursk Regional Oncologic Dispensary, Kursk, , Russian Federation
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology, Moscow, , Russian Federation
State Institution "Blokhin Cancer Research Centre RAMS", Moscow, , Russian Federation
Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD, Moscow, , Russian Federation
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway, Moscow, , Russian Federation
State Budgetary Healthcare Institution "Nizhny Novgorod Regional Oncological Dispensary", Nizhny Novgorod, , Russian Federation
Budgetary Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary", Omsk, , Russian Federation
Petrov Research Oncology Institute, Saint Petersburg, , Russian Federation
Name: Zung Thai, MD
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR