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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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