Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

PHASE3CompletedINTERVENTIONAL
Enrollment

564

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Metastatic Renal Cell Carcinoma
Interventions
DRUG

Dovitinib

Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language.

DRUG

Sorafenib

Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.

Trial Locations (199)

1000

Novartis Investigative Site, Brussels

1086

Novartis Investigative Site, Budapest

1090

Novartis Investigative Site, Vienna

1200

Novartis Investigative Site, Brussels

2065

Novartis Investigative Site, St Leonards

2145

Novartis Investigative Site, Westmead

3000

Novartis Investigative Site, Leuven

3011

Novartis Investigative Site, Footscray

3084

Novartis Investigative Site, Heidelberg

4000

Novartis Investigative Site, Liège

4032

Novartis Investigative Site, Debrecen

4101

Novartis Investigative Site, South Brisbane

5011

Novartis Investigative Site, Woodville

6231

Novartis Investigative Site, Meerssen

7624

Novartis Investigative Site, Pécs

9000

Novartis Investigative Site, Ghent

9007

Novartis Investigative Site, Sankt Gallen

10060

Novartis Investigative Site, Candiolo

10098

Novartis Investigative Site, Berlin

10700

Novartis Investigative Site, Bangkok

11211

Novartis Investigative Site, Riyadh

12180

New York Oncology Hematology, P.C. Dept. of New York Oncology. PC, Troy

13210

SUNY - Upstate Medical University Div. of Hematology-Oncology, Syracuse

13273

Novartis Investigative Site, Marseille

14004

Novartis Investigative Site, Córdoba

14021

Novartis Investigative Site, Caen

15706

Novartis Investigative Site, Santiago de Compostela

17475

Novartis Investigative Site, Greifswald

20133

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

21201

University of Maryland Medical Center UMMC, Baltimore

25030

Novartis Investigative Site, Besançon

26100

Novartis Investigative Site, Cremona

27100

Novartis Investigative Site, Pavia

28007

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28922

Novartis Investigative Site, Alcorcón

29010

Novartis Investigative Site, Málaga

29425

Medical University of South Carolina -Hollings Cancer Center Med Univ SC, Charleston

29605

Cancer Centers of the Carolinas CC of C -Eastside, Greenville

30607

University Cancer & Blood Center, LLC, Athens

30625

Novartis Investigative Site, Hanover

31008

Novartis Investigative Site, Pamplona

31059

Novartis Investigative Site, Toulouse

33006

Novartis Investigative Site, Oviedo

33075

Novartis Investigative Site, Bordeaux

33901

Florida Cancer Specialists DeptofFloridaCancerSpecialists, Fort Myers

35016

Novartis Investigative Site, Las Palmas de Gran Canarias

35039

Novartis Investigative Site, Marburg

35062

Novartis Investigative Site, Rennes

37232

Vanderbilt University Medical Center SC, Nashville

37404

Sarah Cannon Research Institute SC - 3, Chattanooga

38043

Novartis Investigative Site, Grenoble

38120

The West Clinic, Memphis

41014

Novartis Investigative Site, Seville

41100

Novartis Investigative Site, Modena

42271

Novartis Investigative Site, Saint-Priest-en-Jarez

44805

Novartis Investigative Site, Saint-Herblain Cédex

46009

Novartis Investigative Site, Valencia

46010

Novartis Investigative Site, Valencia

47014

Novartis Investigative Site, Meldola

48149

Novartis Investigative Site, Münster

48201

Karmanos Cancer Institute Dept.of KarmanosCancerInst (5), Detroit

49100

Novartis Investigative Site, Petah Tikva

52100

Novartis Investigative Site, Arezzo

54511

Novartis Investigative Site, Vandoeuvre-Les-Nancy Cede

55455

University of Minnesota Medical Center - Fairview Univ of MN, Minneapolis

63011

Novartis Investigative Site, Clermont-Ferrand

63739

Novartis Investigative Site, Aschaffenburg

66160

University of Kansas Cancer Center Univ of KS, Kansas City

69120

Novartis Investigative Site, Heidelberg

69373

Novartis Investigative Site, Lyon

70300

Novartis Investigative Site, Zrifin

72703

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville

75015

Novartis Investigative Site, Paris

75246

Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (4), Dallas

75251

Texas Oncology Texas Onc - Austin, Dallas

Texas Oncology Texas Oncology - Houston, Dallas

75651

Novartis Investigative Site, Paris

77598

Deke Slayton Cancer Center Deke Slayton Cancer Center (2), Webster

80132

Novartis Investigative Site, Napoli

81675

Novartis Investigative Site, München

83310

Novartis Investigative Site, Bratislava

84106

Utah Cancer Specialists Dept.of Utah Cancer Spec. (3), Salt Lake City

89081

Novartis Investigative Site, Ulm

89109

Comprehensive Cancer Centers of Nevada CCC of Nevada (1), Las Vegas

90033

Memorial Sloan Kettering Cancer Center Dept. of MSKCC, New York

90048

Cedars Sinai Medical Center Cedars Sinai Medical Ctr. (SC), Los Angeles

90095

University of California at Los Angeles UCLA (4), Los Angeles

90419

Novartis Investigative Site, Nuremberg

91054

Novartis Investigative Site, Erlangen

92150

Novartis Investigative Site, Suresnes

92637

Novartis Investigative Site, Weiden

94304

Stanford University Medical Center Cancer Clinical Trials Office, Stanford

94805

Novartis Investigative Site, Villejuif

96813

Straub Clinic & Hospital Straub, Honolulu

96817

Moanalua Medical Center. Attn: Oncology Dept, Honolulu

97404

Willamette Valley Clinical Studies Williamette Valley Cancer, Eugene

99202

Rockwood Clinic Spokane Location, Spokane

5266202

Novartis Investigative Site, Ramat Gan

92093-0658

University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5), La Jolla

Unknown

Rocky Mountain Cancer Centers RMCC, Greenwood Village

St. Luke's Hospital and Health Network St Luke's, Bethlehem

Novartis Investigative Site, Bogotá

08043

CINJ at Cooper University Hospital Cooper, Voorhees Township

75390-9034

University of Texas Southwestern Medical Center UTSW, Dallas

22908-0334

University of Virginia Health Systems Univ Virginia, Charlottesville

C1050AAK

Novartis Investigative Site, Buenos Aires

S200DSK

Novartis Investigative Site, Rosario

A-4020

Novartis Investigative Site, Linz

90610-000

Novartis Investigative Site, Porto Alegre

T2N 4N2

Novartis Investigative Site, Calgary

T6G 1Z2

Novartis Investigative Site, Edmonton

V5Z 4E6

Novartis Investigative Site, Vancouver

B3H 2Y9

Novartis Investigative Site, Halifax

L8N 4A6

Novartis Investigative Site, Hamilton

N6A 4L6

Novartis Investigative Site, London

K1H 8L6

Novartis Investigative Site, Ottawa

M4N 3M5

Novartis Investigative Site, Toronto

M5G 2M9

Novartis Investigative Site, Toronto

H2L 4M1

Novartis Investigative Site, Montreal

H2X 1N8

Novartis Investigative Site, Montreal

H3T 1E2

Novartis Investigative Site, Montreal

S7N 4H4

Novartis Investigative Site, Saskatoon

656 53

Novartis Investigative Site, Brno

775 20

Novartis Investigative Site, Olomouc

150 06

Novartis Investigative Site, Prague

06189

Novartis Investigative Site, Nice

F-67098

Novartis Investigative Site, Strasbourg

09119

Novartis Investigative Site, Chemnitz

07740

Novartis Investigative Site, Jena

04103

Novartis Investigative Site, Leipzig

115 28

Novartis Investigative Site, Athens

115 27

Novartis Investigative Site, Athens

546 45

Novartis Investigative Site, Thessaloniki

H-1122

Novartis Investigative Site, Budapest

H-5000

Novartis Investigative Site, Szolnok

00152

Novartis Investigative Site, Roma

466-8560

Novartis Investigative Site, Nagoya

260-8717

Novartis Investigative Site, Chiba

791-0295

Novartis Investigative Site, Tōon

812-8582

Novartis Investigative Site, Fukuoka

734-8551

Novartis Investigative Site, Hiroshima

080-0016

Novartis Investigative Site, Obihiro

060-8648

Novartis Investigative Site, Sapporo

650-0017

Novartis Investigative Site, Kobe

650-0047

Novartis Investigative Site, Kobe

236 0037

Novartis Investigative Site, Yokohama

241-8515

Novartis Investigative Site, Yokohama

602-8566

Novartis Investigative Site, Kyoto

390-8621

Novartis Investigative Site, Matsumoto

537-8511

Novartis Investigative Site, Osaka

545-8586

Novartis Investigative Site, Osaka

589-8511

Novartis Investigative Site, Sayama

565-0871

Novartis Investigative Site, Suita

569-8686

Novartis Investigative Site, Takatsuki

350-1298

Novartis Investigative Site, Hidaka

362-0806

Novartis Investigative Site, Kitaadachi-gun

113-8603

Novartis Investigative Site, Bunkyo-ku

135-8550

Novartis Investigative Site, Koto

105-8470

Novartis Investigative Site, Minato-ku

160-8582

Novartis Investigative Site, Shinjuku-ku

162-8666

Novartis Investigative Site, Shinjuku-ku

990-9585

Novartis Investigative Site, Yamagata

1081 HV

Novartis Investigative Site, Amsterdam

4818 CK

Novartis Investigative Site, Breda

3318AT

Novartis Investigative Site, Dordrecht

6229 HX

Novartis Investigative Site, Maastricht

3075 EA

Novartis Investigative Site, Rotterdam

NO-6026

Novartis Investigative Site, Ålesund

-N5021

Novartis Investigative Site, Bergen

02-781

Novartis Investigative Site, Warsaw

04-141

Novartis Investigative Site, Warsaw

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

110 744

Novartis Investigative Site, Seoul

07120

Novartis Investigative Site, Palma de Mallorca

08041

Novartis Investigative Site, Barcelona

08208

Novartis Investigative Site, Sabadell

08916

Novartis Investigative Site, Badalona

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

03501

Novartis Investigative Site, Benidorm

SE-171 76

Novartis Investigative Site, Stockholm

851 86

Novartis Investigative Site, Sundsvall

SE-901 85

Novartis Investigative Site, Umeå

SE-751 85

Novartis Investigative Site, Uppsala

BS2 8ED

Novartis Investigative Site, Bristol

HA6 2RN

Novartis Investigative Site, Northwood

CO3 3NB

Novartis Investigative Site, Colchester

LE1 5WW

Novartis Investigative Site, Leicester

NW3 4QG

Novartis Investigative Site, London

SW17 0QT

Novartis Investigative Site, London

M20 9BX

Novartis Investigative Site, Manchester

SO16 6YD

Novartis Investigative Site, Southampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY