A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma

PHASE3CompletedINTERVENTIONAL
Enrollment

517

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

July 31, 2012

Study Completion Date

June 30, 2013

Conditions
Advanced Renal Cell Carcinoma
Interventions
DRUG

tivozanib (AV-951)

Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.

DRUG

Sorafenib

Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.

Trial Locations (86)

1431

Site 404, Sofia

1756

Site 400, Sofia

3077

Site 102, Sante Fe

4004

Site 403, Plovdiv

5000

Site 402, Veliko Tarnovo

9002

Site 401, Varna

10065

Site 186, New York

11000

Site 480, Belgrade

Site 481, Belgrade

Site 482, Belgrade

13009

Site 130, Marseille

14029

Site 491, Chernihiv

18000

Site 483, Niš

21204

Site 484, Kamenitz

27100

Site 161, Pavia

32625

Site 180, Gainesville

32806

Site 184, Orlando

44805

Site 133, Saint-Herblain

49005

Site 498, Dnipropetrovsk

49102

Site 492, Dniproperovsk

52100

Site 160, Arezzo

55455

Site 182, Minneapolis

61037

Site 494, Kharkiv

69600

Site 495, Zaporizhia

75246

Site 187, Dallas

76000

Site 490, Ivano-Frankivsk

83092

Site 493, Donetsk

Site 496, Donetsk

88014

Site 497, Uzhhorod

90095

Site 185, Los Angeles

105077

Site 454, Moscow

110085

Site 154, Delhi

115478

Site 453, Moscow

Site 458, Moscow

Site 460, Moscow

Site 461, Moscow

125284

Site 462, Moscow

150054

Site 464, Yaroslavi

193312

Site 466, Saint Petersburg

198255

Site 465, Saint Petersburg

226003

Site 158, Lucknow

249036

Site 456, Obninsk

300239

Site 442, Timișoara

302004

Site 191, Jaipur

302013

Site 155, Jaipur

344022

Site 457, Rostov-on-Don

357500

Site 463, Pyatigorsk

380015

Site 156, Ahmedabad

411004

Site 153, Pune

411005

Site 159, Pune

420029

Site 452, Kazan'

422005

Site 151, Nashik

424037

Site 468, Yoshkar-Ola

450054

Site 459, Ufa

454087

Site 451, Chelyabinsk

500004

Site 157, Hyderabad

500085

Site 444, Brasov

603109

Site 450, Nizhny Novgorod

620102

Site 455, Yekaterinburg

632004

Site 152, Vellore

644013

Site 467, Omsk

700054

Site 150, Kolkata

801505

Site 190, Patna

4810469

Site 123, Temuco

7510009

Site 121, La Reina

8320000

Site 122, Santiago

H2X 1N8

Site 110, Montreal

180 81

Site 411, Prague

H-1108

Site 423, Budapest

H-7400

Site 421, Kaposvár

H-7624

Site 422, Pécs

H-9700

Site 424, Szombathely

00152

Site 162, Roma

15-027

Site 432, Bialystok

85-168

Site 434, Bydgoszcz

80-952

Site 431, Gdansk

10-228

Site 435, Olsztyn

61-878

Site 433, Poznan

02-781

Site 430, Warsaw

04-141

Site 436, Warsaw

022328

Site 441, Bucharest

041345

Site 440, Bucharest

050659

Site 443, Bucharest

CB2 0QQ

Site 170, Cambridge

IP4 5WW

Site 173, Ipswich

LE1 5WW

Site 172, Leicester

Sponsors
All Listed Sponsors
lead

AVEO Pharmaceuticals, Inc.

INDUSTRY