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Spots Global Cancer Trial Database for Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer

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Trial Identification

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

Conditions

Thyroid Cancer

Interventions

XL184
Placebo

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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