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Brief Title: A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Official Title: A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Study ID: NCT02993731
Brief Summary: This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
Clearview Cancer Institute (CCI), Huntsville, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic, Phoenix, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Los Angeles Hematology Oncology Medical Group, Los Angeles, California, United States
University of Southern California, Los Angeles, California, United States
St. Joseph Hospital of Orange, Orange, California, United States
Torrance Health Association DBA Torrance Memorial, Redondo Beach, California, United States
UC Davis, Sacramento, California, United States
UCLA Medical Center Santa Monica Hematology And Oncology, Santa Monica, California, United States
Kaiser Permanente - Vallejo Medical Center, Vallejo, California, United States
Norwalk Hospital The C Anthony and Jean Whittingham Cancer Center, Norwalk, Connecticut, United States
The C Anthony and Jean Whittingham Cancer Center, Norwalk, Connecticut, United States
Helen F. Graham Cancer Center, Newark, Delaware, United States
Georgetown University Medical Center (GUMC), Washington, District of Columbia, United States
Florida Cancer Specialists & Research Institute, Fort Myers, Florida, United States
Memorial Regional Hospital, Hollywood, Florida, United States
Mayo Clinic Cancer Center, Jacksonville, Florida, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
UF Health Cancer Center - Orlando Health, Orlando, Florida, United States
Florida Cancer Specialists North, Saint Petersburg, Florida, United States
Florida Cancer Specialists East Region, Wellington, Florida, United States
University Cancer & Blood Center, Athens, Georgia, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Columbus Regional Research Institute, Columbus, Georgia, United States
Saint Alphonsus Health System, Boise, Idaho, United States
NorthShore University Health Systems, Evanston, Illinois, United States
Ingalls Cancer Research Center, Harvey, Illinois, United States
Carle Cancer Center CCOP, Urbana, Illinois, United States
Northwestern Medicine Regional Medical Group, Warrenville, Illinois, United States
Parkview Physician Group (PPG), Fort Wayne, Indiana, United States
Indiana University - Melvin and Bren Simon Cancer, Indianapolis, Indiana, United States
Cotton O'Neil Cancer Center, Topeka, Kansas, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Louisiana Hematology Oncology Associates (LHOA), Baton Rouge, Louisiana, United States
Maine Center for Cancer Medicine - Scarborough, Scarborough, Maine, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
UMass Memorial Medical Center, Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
St. Luke's Hospital of Duluth, Duluth, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Metro MN Clinical Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Jackson Oncology Associates, Jackson, Mississippi, United States
University of Missouri - Ellis Fischel Cancer Cent, Columbia, Missouri, United States
Saint Luke's Hospital, Kansas City, Missouri, United States
HCA Midwest Division (Kansas City), Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Clinic - Cancer & Hematology, Springfield, Missouri, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Englewood Hospital and Medical Center, Englewood, New Jersey, United States
UNM Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Montefiore Cancer Center, Bronx, New York, United States
Basset Medical Center, Cooperstown, New York, United States
North Shore Hematology Oncology Associates PC, East Setauket, New York, United States
Hematology Oncology Associates of Central New York, East Syracuse, New York, United States
Clinical Research Alliance, Lake Success, New York, United States
Weill Cornell Medicine/ NewYork-Presbyterian, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Stony Brook University, Stony Brook, New York, United States
UNC Chapel Hill / Lineberger Comprehensive Cancer, Chapel Hill, North Carolina, United States
Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States
Cone Health Cancer Center, Greensboro, North Carolina, United States
FirstHealth Outpatient Cancer Center, Pinehurst, North Carolina, United States
Wake Forest Baptist Hospital, Winston-Salem, North Carolina, United States
Gabrail Cancer Center (GCC) - Canton Facility, Canton, Ohio, United States
Toledo Clinic Cancer Centers, Toledo, Ohio, United States
Cancer Center of Southwest Oklahoma, Lawton, Oklahoma, United States
Mercy Clinic Oncology and Hematology - McAuley, Oklahoma City, Oklahoma, United States
Kaiser Permanente - Westside Medical Office, Hillsboro, Oregon, United States
OHSU Knight Cancer Institute, Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Fox Chase Cancer Center (FCCC) - Philadelphia, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Charleston Hematology Oncology Associates, Charleston, South Carolina, United States
Medical University of South Carolina (MUSC), Charleston, South Carolina, United States
Saint Francis Cancer Center, Greenville, South Carolina, United States
GHS Cancer Institute, Greenville, South Carolina, United States
Avera Medical Group, Sioux Falls, South Dakota, United States
Tennessee Oncology Chattanooga, Chattanooga, Tennessee, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
SCRI - Tennessee Oncology, Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Bon Secours Cancer Institute Medical Oncology, Midlothian, Virginia, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Roanoke, Virginia, United States
The Everett Clinic, Everett, Washington, United States
MultiCare Institute for Research and Innovation, Tacoma, Washington, United States
West Virginia University Mary Babb Randolph Cancer Center (MBRCC), Morgantown, West Virginia, United States
HSHS St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Green Bay Oncology, Ltd. - West Green Bay, Green Bay, Wisconsin, United States
Aurora St. Luke's Medical Center - Vince Lombardi, Milwaukee, Wisconsin, United States
Border Medical Oncology, East Albury, New South Wales, Australia
Macquarie University Hospital, Sydney, New South Wales, Australia
ICON Cancer Care, South Brisbane, South Australia, Australia
Cabrini Hospital, Malvern, Victoria, Australia
Blacktown Cancer and Haematology Centre, Blacktown, , Australia
Border Medical Oncology, East Albury, , Australia
The Austin Hospital, Heidelberg, , Australia
Cabrini Hospital, Malvern, , Australia
Sir Charles Gairdner Hospital, Nedlands, , Australia
Prince of Wales Private Hospital, Randwick, , Australia
ICON Cancer Care, South Brisbane, , Australia
Macquarie University Hospital, Sydney, , Australia
The Tweed Hospital, Tweed Heads, , Australia
Sydney Adventist Hospital, Wahroonga, , Australia
LKH Universitätsklinikum Graz, Graz, , Austria
Landeskrankenhaus Medical University Innsbruck, Innsbruck, , Austria
Landeskrankenhaus Feldkirch, Rankweil, , Austria
Universitatsklinik far Innere Medizin III, Salzburg, , Austria
Medical University Vienna, Vienna, , Austria
ULB Erasme, Bruxelles, , Belgium
Antwerp University Hospital, Edegem, , Belgium
UZ Ghent, Gent, , Belgium
UZ Brussel, Jette, , Belgium
UZ Leuven, Leuven, , Belgium
CHU de Liege, Liège, , Belgium
CHU Dinant Godinne, Yvoir, , Belgium
Dr. Everett Chalmers Regional Hospital, Fredericton, New Brunswick, Canada
The Atlantic Clinical Cancer Research Unit (ACCRU), Halifax, Nova Scotia, Canada
Centre Hospitalier de St. Mary, Pointe-Claire, Quebec, Canada
Ciusssmcq, Trois-Rivières, Quebec, Canada
Cross Cancer Institute, Edmonton, , Canada
University of Toronto - St. Michael's Hospital, Toronto, , Canada
Beijing Cancer Hospital, Beijing, , China
Chinese PLA General Hospital, Beijing, , China
Jilin Cancer Hospital, Changchun, , China
The first hospital of jilin university, Changchun, , China
Fujian Medical University Union Hospital, Fuzhou, , China
Cancer Center of Guangzhou Medical University, Guangzhou, , China
Guangdong General Hospital, Guangzhou, , China
The First Affiliated Hospital Zhejiang University, Hangzhou, , China
The Second Affiliated Hospital Zhejiang University, Hangzhou, , China
Sir Run Shaw Hospital School of Medicine Zhejiang University, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
The First Affiliated Hospital of Anhui Medical University, Hefei, , China
The Second Affiliated Hospital of Anhui Medical University, Hefei, , China
The 81 Hospital of the Chinese Peoples Liberation Army, Nanjing, , China
Jiangsu Cancer Hospital, Nanjing, , China
The Affiliated Hospital of Qingdao University, Qingdao, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Huashan Hospital, Shanghai, , China
Ren Ji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, , China
East Hospital of Tongji University, Shanghai, , China
The First Affiliated Hospital of Soochow University, Suzhou, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
The First Affiliated Hospital of Xian Jiao Tong University, Xian, , China
General Hospital of Ningxia Medical University, Yinchuan, , China
Henan Cancer Hospital, Zhengzhou, , China
Onkologicke oddeleni, Benešov, , Czechia
Fakultni nemocnice Brno Interni hematoonkologicka klinika, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
University Hospital Olomouc, Olomouc, , Czechia
Onkologické oddělení, Zlín, , Czechia
Hôpital Sud - CHU Amiens Picardie, Amiens, , France
Hôpital Trousseau, CHRU de Tours, Chambray-lès-Tours, , France
Hopital Edourard Herriot, Lyon Cedex 03, , France
CHU-Hôtel Dieu, Nantes Cedex 1, , France
Centre Antoine Lacassagne, Nice, , France
Hopital Europeen Georges Pompidou, Paris, , France
Poitiers University Hospital, Poitiers, , France
Centre Eugene Marquis, Rennes, , France
Clinique Saint Anne, Strasbourg, , France
Hopital Civil de strasbourg, Strasbourg, , France
Institute de Cancerologie de Lorraine, Vandœuvre-lès-Nancy, , France
Gesundheitszentrum St. Marien GmbH, Amberg, , Germany
University Hospital Bonn, Bonn, , Germany
Klinikum Chemnitz, Chemnitz, , Germany
Krankenhaus Nordwest, Frankfurt am main, , Germany
Medizinische Hochschule, Hannover, , Germany
SLK-Kliniken Heilbronn GmbH, Heilbronn, , Germany
Universitätsmedizin Mannheim, Mannheim, , Germany
Klinikum Bogenhausen, München, , Germany
Klinikum Oldenburg AöR - UK für Innere Medizin, Oldenburg, , Germany
Fondazione Poliambulanza, Brescia, , Italy
Istituto Ricerca e la Cura del Cancro (IRCC), Candiolo, , Italy
AOU Mater Domini, Catanzaro, , Italy
Ospedale degli Infermi, Faenza, , Italy
Santa Maria de Prato Hospital, Feltre, , Italy
IRCCS - Studio e la Cura dei Tumori, Meldola, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
AO SM Misericordia, Perugia, , Italy
IRCCS Azienda Ospedaliera S.Maria Nuova, Reggio Emilia, , Italy
Ospedale degli Infermi, Rimini, , Italy
Dermatological Hospital San Lazzaro, Torino, , Italy
ASST Settelaghi, Varese, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
Shikoku Cancer Center, Matsuyama, Ehime, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Tochigi Cancer Center, Utsunomiya, Tochigi, Japan
University of Tokyo Hospital, Bunkyō-Ku, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR, Koto-Ku, Tokyo, Japan
Kyorin University Hopsital, Mitaka, Tokyo, Japan
Kyoto University Hospital, Kyoto, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
Seoul national University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeongnam, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Medisch Centrum Leeuwarden (MCL), Leeuwarden, , Netherlands
Zuyderland Medical Center, Sittard, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
Isala Ziekenhuis, Zwolle, , Netherlands
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
Centrum Onkologii-Instytut im.M.Sklodowskiej-Curie, Gliwice, , Poland
Przychodnia Lekarska KOMED, Konin, , Poland
Klinika Chirurgii Onkologicznej, Lublin, , Poland
Centrum Onkologii Ziemi Lubelskiej, Lublin, , Poland
Samodzielny Publiczny Szpital Kliniczny, Poznań, , Poland
Wojewodzki Szpital Zespolony, Toruń, , Poland
Fundação Champalimaud, Lisboa, , Portugal
Hospital da Luz, Lisboa, , Portugal
Centro Hospitalar Lisboa Norte, Lisbon, , Portugal
Centro Hospitalar do Porto, E.P.E, Porto, , Portugal
IPO Porto Francisco Gentil, E.P.E., Porto, , Portugal
Centro Hospitalar Entre Douro e Vouga, Santa Maria Da Feira, , Portugal
Kursk Regional Clinical Oncology Dispensary, Kislino, Kursk, Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangel'sk, , Russian Federation
Republican Clinical Oncology Dispensary, Cheboksary, , Russian Federation
Llc Evimed, Chelyabinsk, , Russian Federation
Railway Clinical Hospital on station Chelyabinsk, Chelyabinsk, , Russian Federation
Republic Clinical Oncology Dispensary, Kazan, , Russian Federation
N.N. Blokhin Russian Cancer Research Center, Moscow, , Russian Federation
Privolzhsk District Medical Center, Nizhny Novgorod, , Russian Federation
Budgetary Healthcare Institution of Omsk Region, Omsk, , Russian Federation
Orenburg Regional Clinical Oncology Dispensary, Orenburg, , Russian Federation
Pyatigorsk Oncology Dispensary, Pyatigorsk, , Russian Federation
St.Petersburg Medical Universitet n.a. I.P. Pavlov, Saint Petersburg, , Russian Federation
FSBI "Russian Research Centre of Radiology and Surgical Technologies", Saint Petersburg, , Russian Federation
City Clinical Oncology Dispensary, Saint Petersburg, , Russian Federation
Multi-type clinic 'REAVIZ', Samara, , Russian Federation
National Research Mordovia State University, Saransk, , Russian Federation
National Cancer Centre Singapore, Singapore, , Singapore
Tan Tock Seng Hospital, Singapore, , Singapore
Hospital Vall d´Hebron, Barcelona, , Spain
Hospital Clínico y Provincial de Barcelona, Barcelona, , Spain
(ICO) Hospital Duran i Reynals, Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol, Barcelona, , Spain
Hospital Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Madrid, , Spain
Hospital Universitario Fundacion Alcorcon, Madrid, , Spain
Hospital Regional Universitario de Málaga, Málaga, , Spain
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
LinKou Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Zaytsev Institute General and Urgent Surgery of National Academy Medical Science of Ukraine, Kharkiv, , Ukraine
National Institute of Cancer, Kyiv, , Ukraine