Spots Global Cancer Trial Database for A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy
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Trial Identification
Brief Title: A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy
Official Title: A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination With mFOLFOX6 to Bevacizumab in Combination With mFOLFOX6, In Stage IV Metastatic Colorectal Cancer (mCRC) Subjects
Study ID: NCT01478594
Conditions
Study Description
Brief Summary: The objective of this study is to compare the progression free survival (PFS), overall survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of response (DoR), quality of life, safety and tolerability of tivozanib in combination with mFOLFOX6 and bevacizumab in combination with mFOLFOX6.
Detailed Description: Imaging scans (computed tomography \[CT\]/magnetic resonance imaging \[MRI\]) to assess disease progression were to be completed within 28 days prior to first study drug administration, approximately every 8 weeks for the first 18 months and then approximately every 12 weeks until the patient showed progressive disease (PD) per the investigator, withdrew consent, was lost to follow-up or died. Per the original protocol, all patients were to be contacted by the study site every 12 weeks for survival following the end-of-treatment visit until death or for no more than 3 years after the end-of-treatment visit. The interim futility analysis was conducted in December 2013, based on a pre-specified analysis cutoff date of 13 September 2013. The study was brought to a close as specified in the protocol due to the results of the interim futility analysis and only those participants who were deriving benefit (per the treating physician) from their current treatment remained on study until one of the discontinuation criteria was met. Given the early closure of the study, no updated or additional efficacy analyses were performed after the interim analysis. A biomarker analysis was conducted in January 2014, based on the data from the cutoff date of 13 September 2013. The safety analysis was updated with a new cutoff date of 28 February 2014.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Research Center, Gilbert, Arizona, United States
Genesis Cancer Center, Hot Springs, Arizona, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
University of California San Diego-Morris Cancer Center, La Jolla, California, United States
UC Irvine Medical Center, Division of Hematology/Oncology, Orange, California, United States
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States
Mountain Blue Cancer Care Center, Golden, Colorado, United States
University of Florida, Davis Cancer Center (VA), Gainesville, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
Queen's Medical Center, Honolulu, Hawaii, United States
University of Hawaii, Honolulu, Hawaii, United States
Kaiser Foundation Hospitals, Honolulu, Hawaii, United States
Northwestern University, Chicago, Illinois, United States
Illinios Cancer Care, Peoria, Illinois, United States
Investigative Clinical Research of Indiana, LLC, Indianapolis, Indiana, United States
Horizon Oncology Research, Inc., Lafayette, Indiana, United States
Associates of Oncology Hematology, P.C., Rockville, Maryland, United States
University of Michigan Health, Ann Arbor, Michigan, United States
NYU Cancer Institute, New York, New York, United States
Alamance Regional Medical Center, Burlington, North Carolina, United States
Tri Country Hematology / Oncology, Canton, Ohio, United States
Signal Point Clinical Research Center, LLC, Middletown, Ohio, United States
Cancer Care Associates, Tulsa, Oklahoma, United States
Oregon Health and Science University, Portland, Oregon, United States
Oncology Hematology of Lehigh Valley, Bethlehem, Pennsylvania, United States
Northern Utah Associates, Ogden, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
St George Hospital, Kogarah, New South Wales, Australia
Tweed Hospital, Tweed Heads, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Ballarat Health Services, Ballarat, Victoria, Australia
Cabrini Hospital Malvern, Malvern, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Medizinische Universitat Graz, Graz, , Austria
Salzburger Landesklinken, Salzburg, , Austria
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
Ziekenhuisnetwerk Antwerpen - AZ Middelheim, Antwerpen, , Belgium
Imelda VZW, Bonheiden, , Belgium
AZ Sint-Lucas Brugge, Brugge, , Belgium
AZ Groeninge - Campus Sint-Niklaas, Kortrijk, , Belgium
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
QEII Health Science Centre, Halifax, Nova Scotia, Canada
Hopital De La Cite-De-La-Sante, Laval, Quebec, Canada
Hopital Saint-Luc - Pavillon Principal, Montreal, Quebec, Canada
Chuq Centre Hospitalier Universitaire De Quebec, Quebec, , Canada
Masarykuv onkologicky ustav, Brno, , Czech Republic
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czech Republic
Tampereen yliopistollinen sairaala, Tampere, , Finland
Turun yliopistollinen keskussairaala, Turku, , Finland
Orszagos Onkologiai Intezet, Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz, Gyor, , Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Gyula, , Hungary
Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar, , Hungary
Azienda Ospedaliero- Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna, , Italy
Fondazione del Piemonte per I'Oncologia IRCC, Candiolo, , Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - Istituto Nazionale per la Ricerca sul Cancro, Genova, , Italy
Istituto Clinico Humanitas, Rozzano (MI), , Italy
Amphia Ziekenhuis, Breda, , Netherlands
Hospital Universitario Miguel Servet, Zaragoza, Aragon, Spain
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Corporacio Sanitaria Parc Tauli, Sabadell, Cataluna, Spain
Hospital Mutua de Terrassa, Terrassa, Cataluna, Spain
Centro Oncologico de Galicia, Galicia, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Addenbrooke's Hospital, Cambridge, , United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Center, Glasgow, , United Kingdom
University College Hospital, London, , United Kingdom
Maidstone Hospital, Maidstone, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Peterborough and Stamford Hospitals NHS Foundation Trust, Peterborough, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: AVEO Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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