Spots Global Cancer Trial Database for A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma
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Trial Identification
Brief Title: A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma
Official Title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)
Study ID: NCT01030783
Conditions
Study Description
Brief Summary: This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.
Detailed Description: This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib. Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib and stratified by geographic region (North America/Western Europe, Central/Eastern Europe, or rest of the world); number of prior treatments (0 or 1); and number of metastatic sites/organs involved (1 or ≥ 2).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site 185, Los Angeles, California, United States
Site 180, Gainesville, Florida, United States
Site 184, Orlando, Florida, United States
Site 182, Minneapolis, Minnesota, United States
Site 186, New York, New York, United States
Site 187, Dallas, Texas, United States
Site 102, Sante Fe, , Argentina
Site 403, Plovdiv, , Bulgaria
Site 404, Sofia, , Bulgaria
Site 400, Sofia, , Bulgaria
Site 401, Varna, , Bulgaria
Site 402, Veliko Tarnovo, , Bulgaria
Site 110, Montréal, Quebec, Canada
Site 121, La Reina, Santiago De Chile, Chile
Site 122, Santiago, , Chile
Site 123, Temuco, , Chile
Site 411, Prague 8, , Czechia
Site 130, Marseille, , France
Site 133, Saint Herblain Cedex, , France
Site 423, Budapest, , Hungary
Site 421, Kaposvár, , Hungary
Site 422, Pécs, , Hungary
Site 424, Szombathely, , Hungary
Site 157, Hyderabad, Andhra Pradesh, India
Site 190, Patna, Bihar, India
Site 156, Ahmedabad, Gujarat, India
Site 151, Nashik, Maharashtra, India
Site 153, Pune, Maharashtra, India
Site 159, Pune, Maharashtra, India
Site 191, Jaipur, Rajasthan, India
Site 155, Jaipur, Rajasthan, India
Site 152, Vellore, Tamil Nadu, India
Site 158, Lucknow, Uttar Pradesh, India
Site 150, Kolkata, West Bengal, India
Site 154, Delhi, , India
Site 160, Arezzo, , Italy
Site 161, Pavia, , Italy
Site 162, Roma, , Italy
Site 432, Bialystok, , Poland
Site 434, Bydgoszcz, , Poland
Site 431, Gdansk, , Poland
Site 435, Olsztyn, , Poland
Site 433, Poznan, , Poland
Site 430, Warsaw, , Poland
Site 436, Warsaw, , Poland
Site 444, Brasov, , Romania
Site 441, Bucharest, , Romania
Site 440, Bucharest, , Romania
Site 443, Bucharest, , Romania
Site 442, Timisoara, , Romania
Site 459, Ufa, Republic Of Bashkortostan, Russian Federation
Site 451, Chelyabinsk, , Russian Federation
Site 455, Ekaterinburg, , Russian Federation
Site 468, Ioshkar Ola, , Russian Federation
Site 452, Kazan, , Russian Federation
Site 454, Moscow, , Russian Federation
Site 453, Moscow, , Russian Federation
Site 458, Moscow, , Russian Federation
Site 460, Moscow, , Russian Federation
Site 461, Moscow, , Russian Federation
Site 462, Moscow, , Russian Federation
Site 450, Nizhny Novgorod, , Russian Federation
Site 456, Obninsk, , Russian Federation
Site 467, Omsk, , Russian Federation
Site 463, Pyatigorsk, , Russian Federation
Site 457, Rostov-on-Don, , Russian Federation
Site 466, St. Petersburg, , Russian Federation
Site 465, St. Petersburg, , Russian Federation
Site 464, Yaroslavi, , Russian Federation
Site 480, Belgrade, , Serbia
Site 481, Belgrade, , Serbia
Site 482, Belgrade, , Serbia
Site 483, Nis, , Serbia
Site 484, Sremska Kamenica, , Serbia
Site 491, Chernihiv, , Ukraine
Site 492, Dniproperovsk, , Ukraine
Site 498, Dnipropetrovsk, , Ukraine
Site 493, Donetsk, , Ukraine
Site 496, Donetsk, , Ukraine
Site 490, Ivano-Frankivsk, , Ukraine
Site 494, Kharkiv, , Ukraine
Site 497, Uzhhorod, , Ukraine
Site 495, Zaporizhia, , Ukraine
Site 170, Cambridge, , United Kingdom
Site 173, Ipswich, , United Kingdom
Site 172, Leicester, , United Kingdom
Contact Details
Name: Robert J. Motzer, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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