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Brief Title: Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer
Official Title: An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer
Study ID: NCT00704730
Brief Summary: The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration. The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Comprehensive Cancer Center, Birmingham, Alabama, United States
TGEN Clinical Research Service at Scottsdale Healthcare, Scottsdale, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
, Burbank, California, United States
UCLA, Los Angeles, California, United States
Stanford Cancer Center, Stanford, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Yale University, School of Medicine, New Haven, Connecticut, United States
Washington Cancer Institute, Washington, District of Columbia, United States
H. Lee Moffet Cancer Center and Research Institute, Tampa, Florida, United States
University of Chicago, Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
University of Iowa, Iowa City, Iowa, United States
Kansas University Medical Center, Kansas City, Kansas, United States
Johns Hopkins University, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Capitol Comprehensive Cancer Care Clinic and Research Institute, Jefferson City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Ohio State University, James Cancer Hospital, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
St. Luke's Hospital & Health Network, Bethlehem, Pennsylvania, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Hollings Cancer Center, Charleston, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Vermont Cancer Center at Fletcher Allen Health Care, Burlington, Vermont, United States
Peninsula Cancer Institute, Newport News, Virginia, United States
, Klagenfurt, , Austria
Multiple site locations, Wien, , Austria
Cliniques Universitaires St. Luc, Brussels, , Belgium
Universitair Ziekenhuis, Leuven, , Belgium
, Brasilia, , Brazil
, Lajeado, , Brazil
, Porto Alegre, , Brazil
Multiple site locations, Sao Paulo, , Brazil
, Calgary, Alberta, Canada
, Toronto, Ontario, Canada
CHUM - Hopital Saint-Luc, Montreal, Quebec, Canada
, Sherbrooke, Quebec, Canada
, Santiago, , Chile
, Odense, , Denmark
, Angers, , France
, Bordeaux, , France
, Lyon, , France
, Marseille, , France
, Reims, , France
, Villejuif, , France
Klinik fuer Nuklearmedizin des Universitaetsklinikums Essen, Essen, , Germany
Gemeinschaftspraxis, Heidelberg, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Johannes-Gutenberg Universitaet Mainz, Mainz, , Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen, Muenchen, , Germany
Ludwig-Maximilians-Universitaet Muenchen, Muenchen, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
, Athens, , Greece
Kidwai Institute of Oncology, Bangalore, , India
Indo-American Cancer Institute and Research Center, Hyderabad, , India
SEAROC Cancer Institute, S.K. Soni Hospital, Jaipur, , India
Netaji Subhash Chandra Bose Cancer Hospital Research Institute, Kolkata, , India
Central India Cancer Research Institute, Nagpur, , India
Shatabdi Superspeciality Hospital, Nashik, , India
All India Institute of Medical Sciences, New Dehli, , India
Deenanath Mangeshkar Hospital & Research Center, Pune, , India
Ruby Hall Clinic, Pune, , India
, Haifa, , Israel
, Jerusalem, , Israel
, Petach Tikva, , Israel
, Tel Aviv, , Israel
, Florence, , Italy
, Milan, , Italy
, Naples, , Italy
, Pisa, , Italy
, Rome, , Italy
, Siena, , Italy
, Turin, , Italy
Multiple site locations, Seoul, , Korea, Republic of
, Amsterdam, , Netherlands
, Groningen, , Netherlands
, Leiden, , Netherlands
Multiple site locations, Lima, , Peru
, Bydgoszcz, , Poland
, Gliwice, , Poland
, Pozan, , Poland
, Szczecin, , Poland
, Warszawa, , Poland
, Coimbra, , Portugal
, Oporto, , Portugal
, Porto, , Portugal
, Obninsk, , Russian Federation
, Ufa, , Russian Federation
, Voronezh, , Russian Federation
, Yaroslavl, , Russian Federation
, Riyadh, , Saudi Arabia
Multiple site locations, Barcelona, , Spain
, Madrid, , Spain
, Murcia, , Spain
, Santiago de Compostela, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Gothenburg, , Sweden
, Lund, , Sweden
, Uppsala, , Sweden
, Berne, , Switzerland
, Geneve, , Switzerland
, Cardiff, , United Kingdom
, Glasgow, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, Newcastle Upon Tyne, , United Kingdom
, Oxford, , United Kingdom
, Sheffield, , United Kingdom