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Brief Title: A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
Official Title: A Phase 3 Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).
Study ID: NCT02753127
Brief Summary: This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alabama Oncology, Birmingham, Alabama, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
City of Hope- Comprehensive Care Center, Duarte, California, United States
University of California-San Diego/Moores UCSD Cancer Center, La Jolla, California, United States
Los Angeles Hematology Oncology Medical Group, Los Angeles, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA Hematology Oncology Santa Monica, Santa Monica, California, United States
St. Joseph Heritage Healthcare, Santa Rosa, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
St Mary's Hospital & Regional Med Center, Grand Junction, Colorado, United States
Medical Oncology Hematology Consultants, PA, Newark, Delaware, United States
Florida Cancer Specialists & Research Institute Fort Myers, Fort Myers, Florida, United States
Memorial Cancer Institute at Memorial Hospital, Hollywood, Florida, United States
Baptist Health Medical Group Oncology, LLC, Miami, Florida, United States
Sarah Cannon Research Institution, Saint Petersburg, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Piedmont Cancer Institute, PC, Atlanta, Georgia, United States
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
Suburban Hematology-Oncology Associates, PC - Lawrenceville, Lawrenceville, Georgia, United States
Illinois Cancer Specialists, Arlington Heights, Illinois, United States
Northshore University Healthsystem, Evanston, Illinois, United States
Healthcare Research Network III, LLC, Tinley Park, Illinois, United States
Northwestern Medicine Cancer Center, Warrenville, Illinois, United States
Parkview Research Center, Fort Wayne, Indiana, United States
Indiana University Health Goshen Center for Cancer Care, Goshen, Indiana, United States
Michiana Hematology Oncology, PC, Mishawaka, Indiana, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Dana Farber, Boston, Massachusetts, United States
Umass Memorial Medical Center, Worcester, Massachusetts, United States
University of Michigan Cancer Center, Ann Arbor, Michigan, United States
Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States
Mayo Clinic Arizona, Rochester, Minnesota, United States
Research Medical Center, Kansas City, Missouri, United States
Missouri Baptist Medical Center ACCRU Network Site, Saint Louis, Missouri, United States
Saint Francis Cancer Treatment Center, Grand Island, Nebraska, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Cancer Research Network of Nebraska / Oncology Associates PC, Omaha, Nebraska, United States
Tennessee Oncology PLLC, Omaha, Nebraska, United States
Darthmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Carol G. Simon Cancer Center, Morristown, New Jersey, United States
University of New Mexico, Albuquerque, New Mexico, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Center, Buffalo, New York, United States
North Shore Hematology Oncology Associates, East Setauket, New York, United States
Weill Cornell Medical College, New York, New York, United States
Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
Toledo Clinic Cancer Centers, Toledo, Ohio, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Sanford Cancer Center, Sioux Falls, South Dakota, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
West Cancer Center, Memphis, Tennessee, United States
The Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology-Austin Midtown, Austin, Texas, United States
Texas Oncology - Dallas Center, Dallas, Texas, United States
Texas Oncology - Denton South, Denton, Texas, United States
Texas Oncology - Fort Worth, Fort Worth, Texas, United States
Millenium Oncology, Houston, Texas, United States
Texas Health Physicians Group, Plano, Texas, United States
Texas Oncology-San Antonio, San Antonio, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Texas Oncology - Wichita Falls Texoma Cancer Center, Wichita Falls, Texas, United States
Northern Utah Associates, Ogden, Utah, United States
US Oncology - Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Fort Belvoir Community Hospital, Fort Belvoir, Virginia, United States
Virginia Oncology Associates, Hampton, Virginia, United States
Blue Ridge Cancer Care, Roanoke, Virginia, United States
Virginia Mason, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia
St Vincent's Hospital, Darlinghurst, New South Wales, Australia
St Vincent's hospital Melbourne, Fitzroy, New South Wales, Australia
Port Macquaries Base Hospital, Port Macquarie, New South Wales, Australia
Northern Cancer Institute, St Leonards, New South Wales, Australia
Sunshine Coast Hospital and Health Service, Nambour, Queensland, Australia
Gold Coast University Hosptial, Southport, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital, Woodville, South Australia, Australia
Bendigo Hospital, Bendigo, Victoria, Australia
Peninsula & South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Western Health, Melbourne, Victoria, Australia
Goulburn Valley Health, Shepparton, Victoria, Australia
Prince of Wales Hospital, Randwick, , Australia
Imelda Ziekenhuis, Bonheiden, Antwerpen, Belgium
Imelda Ziekenhuis, Bonheiden, Antwerpen, Belgium
Imelda Ziekenhuis, Bonheiden, Antwerpen, Belgium
AZ Turnhout - Campus Sint-Elisabeth, Turnhout, Antwerpen, Belgium
Hôpital Erasme, Bruxelles, Brussels Capital Region, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame, Charleroi, Hainaut, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman, Bruxelles, Liège, Belgium
UZ Leuven - Campus Gasthuisberg, Leuven, Vlaams Brabant, Belgium
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan, Brugge, West-Vlaanderen, Belgium
AZ Sint-Lucas - Campus Sint-Lucas, Brugge, West-Vlaanderen, Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
University of Toronto - Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Saint Michael's Hospital Li Ka Shing Knowledge Institute, Toronto, Ontario, Canada
St. Mary's Hospital Center, Montréal, Quebec, Canada
Hopital Notre-Dame du CHUM, Montréal, Quebec, Canada
Beijing Cancer Hospital, Beijing, , China
Henan Cancer Hospital, Henan, , China
Jiangsu Province Hospital, Jiangsu, , China
FN Hradec Kralove, Hradec Králové, Královéhradecký Kraj, Czechia
Fakultni nemocnice Brno, Brno, , Czechia
Masarykuv onkologicky ustav, Brno, , Czechia
Vseobecna fakultni nemocnice v Praze, Prague, , Czechia
Centre Paul Papin, Angers, , France
Hospitalier Jean Minjoz, Besançon, , France
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématolog, Brest, , France
CHU Estaing, Clermont Ferrand, , France
Centre de Lutte Contre le Cancer (CLCC), Dijon, , France
CHU de Nantes - Hopital Hotel Dieu, Nantes, , France
Hôpital Européen Georges Pompidou - Digestive Oncology, Paris, , France
Hôpital Privé des Côtes d'Armor - Service oncologie, Plérin, , France
Hospital of Poitiers, Poitiers, , France
Centre Eugene Marquis, Rennes, , France
Centre Rene Gauducheau, Saint-Herblain, , France
Leopoldina Krankenhaus Med. Klinik 2, Schweinfurt, Bayern, Germany
Schwerpunkpraxis für Hämatologie und Onkologie, Magdeburg, Sachsen-Anhalt, Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Sachsen, Germany
Gesundheitszentrum Wetterau, Bad Nauheim, , Germany
Vivantes Klinikum Am Urban, Berlin, , Germany
Charite - Campus Benjamin Franklin (Cbf), Berlin, , Germany
DRK Kliniken Berlin Koepenick, Berlin, , Germany
Charité Universitätsmedizin, Berlin, , Germany
MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim, Berlin, , Germany
Facharztzentrum Eppendorf, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Universitätsklinikum Marburg, Marburg, , Germany
Medizinische Universitaetsklin, Ulm, , Germany
Pamela Youde Nethersole Eastern Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Ha'Emek Medical Center, Afula, , Israel
The Barzilai Medical Center - Oncology Institute, Ashkelon, , Israel
Soroka University Medical Center, Be'er Sheva, , Israel
Shaare Zedek Medical center, Jerusalem, , Israel
Meir Medical Center, Kefar Saba, , Israel
Rabin MC - Oncology, Davidoff Center, Petah tikva, , Israel
Ziv Medical Center (The Rebecca Sieff Hospital), Safed, , Israel
The Chaim Sheba Medical Centre - Division of Oncology, Tel HaShomer, , Israel
Tel Aviv Sourasky Medical Center - Oncology, Tel-Aviv, , Israel
AOU Ospedali Riuniti Umberto I - GM.Lanc, Torrette Di Ancona, Ancona, Italy
Ospedale Santa Maria del Prato, Feltre, Belluno, Italy
Irccs Irst, Meldola, Forli, Italy
AUSL della Romagna, Osp. degli Infermi, Faenza, Ravenna, Italy
Policlinico S.Orsola Malpighi, AOU di Bologna, Bologna, , Italy
PO di Cremona, ASST di Cremona, Cremona, , Italy
AO S. Martino, IRCCS, IST, Genova, , Italy
Ieo, Irccs, Milano, , Italy
AOU Policlinico di Modena, Modena, , Italy
Università degli studi della Campania "L.Vanvitelli", Napoli, , Italy
Ospedale Guglielmo da Saliceto, AUSL Piacenza, Piacenza, , Italy
AOU Città della Salute e della Scienza di Torino - Molinette, Torino, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsunami, Ehime, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
ST. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan
Osaka University Hospital, Suita, Osaka, Japan
Osaka Medical College Hospital, Takatsuki, Osaka, Japan
Saitama Cancer Center, Kita-Adachi, Saitama, Japan
Shizuoka Cancer Center, Sunto, Shizuoka, Japan
Medical Hospital, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
The cancer insitute hospital of JFCR (Japanese Foundation For Cancer Research), Koto-ku, Tokyo, Japan
National Kyushu Cancer Center, Fukuoka, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, , Japan
National Hospital Organization Osaka National Hospital, Osaka, , Japan
Yeungnam University Medical Center, Daegu, Daegu Gwang'yeogsi, Korea, Republic of
National Cancer Centre, Goyang, Gyeonggido, Korea, Republic of
Ajou University Hospital, Suwon, Gyeonggido, Korea, Republic of
Gachon University Gil Medical Center, Incheon, Incheon Gwang'yeogsi, Korea, Republic of
Korea University Anam Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Korea University Guro Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Medisch Centrum Leeuwarden, Leeuwarden, Friesland, Netherlands
Academisch Medisch Centrum, Amsterdam, , Netherlands
Spaarne Gasthuis, Hoofddorp, , Netherlands
Maastricht UMC, Maastricht, , Netherlands
Elizabeth Tweesteden Ziekenhuis locatie Tilburg, Tilburg, , Netherlands
National University Cancer Institute, Singapore, Central Singapore, Singapore
National Cancer Centre, Singapore, Central Singapore, Singapore
Raffles Hospital, Singapore, Central Singapore, Singapore
Hospital General Universitario de Elche, Elche, Alicante, Spain
H.U.V. del Rocío, Sevilla, Andalucía, Spain
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Complexo Hospital Universitario A Coruña, A Coruña, Galicia, Spain
Hospital Universitario Fundacion Alcorcon (HUFA), Alcorcón, Madrid, Spain
Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda, Madrid, Spain
Consorci Hospital General Universitari Valencia (CHGUV), Comunidad Valenciana, Valencia, Spain
Hospital Son Llatzer, Baleares, , Spain
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Universitario Gregorio Marañón, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca, Murcia, , Spain
Hospital Universitario Virgen de la Macarena, Sevilla, , Spain
H.C.U.Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain