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Brief Title: Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients
Official Title: Adjuvant Axitinib Treatment of Renal Cancer: A Randomized Double-blind Phase 3 Study of Adjuvant Axitinib vs. Placebo in Subjects at High Risk of Recurrent RCC
Study ID: NCT01599754
Brief Summary: The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.
Detailed Description: This is a prospective, randomized, double blind placebo controlled Phase 3 trial of oral axitinib starting at 5 mg twice daily given 3 years vs. placebo. Approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, La Jolla, California, United States
, Los Angeles, California, United States
, Palo Alto, California, United States
, Pleasant Hill, California, United States
, Denver, Colorado, United States
, Washington, District of Columbia, United States
, Ocala, Florida, United States
, Atlanta, Georgia, United States
, Annapolis, Maryland, United States
, Baltimore, Maryland, United States
, Saint Paul, Minnesota, United States
, Omaha, Nebraska, United States
, Hackensack, New Jersey, United States
, Albany, New York, United States
, New York, New York, United States
, Portland, Oregon, United States
, Charleston, South Carolina, United States
, Chattanooga, Tennessee, United States
, Austin, Texas, United States
, Bedford, Texas, United States
, Dallas, Texas, United States
, Houston, Texas, United States
, San Antonio, Texas, United States
, San Antonio, Texas, United States
, Norfolk, Virginia, United States
, Seattle, Washington, United States
, Beijing, , China
, Changchun, , China
, Chongqing, , China
, Dalian, , China
, Guangzhou, , China
, Hangzhou, , China
, Jinan, , China
, Nanchang, , China
, Shanghai, , China
, Suzhou, , China
, Tianjin, , China
, Wuhan, , China
, Besançon, , France
, Bordeaux Cedex, , France
, Hyères, , France
, Le Mans Cedex 02, , France
, Lyon, , France
, Marseille cedex 5, , France
, Paris Cedex 15, , France
, Rennes Cedex, , France
, Saint Herblain, , France
, Suresnes Cedex, , France
, Vandoeuvre les Nancy Cedex, , France
, Hong Kong, , Hong Kong
, Ahmeadbad, , India
, Aurangabad, , India
, Bangalore, , India
, Chennai, , India
, Hyderabad, , India
, Karamsad, , India
, Kochi, , India
, Kolkota, , India
, Lucknow, , India
, Ludhiana, , India
, Mangalore, , India
, Manipal, , India
, Mumbai, , India
, Nashik, , India
, New Delhi, , India
, Pune, , India
, Surat, , India
, Vishakhapatnam, , India
, Aichi, , Japan
, Akita, , Japan
, Aomori, , Japan
, Chiba, , Japan
, Fukuoka, , Japan
, Gifu, , Japan
, Hokkaido, , Japan
, Hyogo, , Japan
, Kagawa, , Japan
, Kanagawa, , Japan
, Kumamoto, , Japan
, Kyoto, , Japan
, Nagasaki, , Japan
, Nigata, , Japan
, Osaka, , Japan
, Shizuoka, , Japan
, Tokushima, , Japan
, Tokyo, , Japan
, Yamagata, , Japan
, Yamaguchi,, , Japan
, Busan, , Korea, Republic of
, Daegu, , Korea, Republic of
, Daejeon, , Korea, Republic of
, Gyeonggi, , Korea, Republic of
, Jeonnam, , Korea, Republic of
, Seoul, , Korea, Republic of
, Barcelona, , Spain
, Leganes, , Spain
, Llobregat, , Spain
, Madrid, , Spain
, Oviedo, , Spain
, San Sebastian, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Zaragoza, , Spain
, Taichung, , Taiwan
, Taipei, , Taiwan
, Taoyuan, , Taiwan