Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

471

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
Renal Cell Carcinoma
Interventions
DRUG

everolimus

Everolimus was administered orally at 10 mg/day. Everolimus is formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.

DRUG

sunitinib

Sunitinib was administered orally 50 mg daily, on a schedule of 4 weeks on/2 weeks off. Sunitinib was supplied as hard gelatin capsules of 12.5 mg, 25 mg, or 50 mg strength according to local practice.

Trial Locations (84)

11

Novartis Investigative Site, Jesus Maria

112

Novartis Investigative Site, Taipei

5011

Novartis Investigative Site, Woodville

10065

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

10098

Novartis Investigative Site, Berlin

10700

Novartis Investigative Site, Bangkok

11042

Clinical Research Alliance, Lake Success

13210

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

18015

St. Luke's Hospital and Health Network St Luke's Hospital (2), Bethlehem

21201

VA Maryland Health Care Dept.of GreenbaumCancerCent(7), Baltimore

25198

Novartis Investigative Site, Lleida

27710

Duke University Medical Center Duke, Durham

28203

Levine Cancer Institute Oncology, Charlotte

30607

University Cancer & Blood Center, LLC Dept of NE GCC (2), Athens

30912

Georgia Health Sciences University Dept. of MCG, Augusta

31000

Novartis Investigative Site, Chihuahua City

31405

Summit Cancer Care, Savannah

32806

MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando, Orlando

33136

University of Miami SC, Miami

33486

Lynn Cancer Institute, Boca Raton

34093

Novartis Investigative Site, Istanbul

36688

University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst., Mobile

38120

The West Clinic Dept. of the West Clinic, Memphis

41013

Novartis Investigative Site, Seville

41100

Novartis Investigative Site, Modena

49055

Novartis Investigative Site, Angers

52100

Novartis Investigative Site, Arezzo

53215

Aurora Advanced Healthcare SC, Milwaukee

54511

Novartis Investigative Site, Vandoeuvre-Les-Nancy Cede

59020

Novartis Investigative Site, Lille

59107

Billings Clinic Dept of Billings Clinic(2), Billings

60153

Loyola University Medical Center /Cardinal Bernardin Cancer Cardinal Bernardin Cancer (3), Maywood

60611

NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept.ofNorthwesternMemHospital, Chicago

63739

Novartis Investigative Site, Aschaffenburg

70006

Crescent City Research Consortium, LLC SC, Metairie

72703

Highlands Oncology Group HighlandsOncGrp-Bentonville(2), Fayetteville

73104

University of Oklahoma Health Sciences Center Dept of OHSC, Oklahoma City

75015

Novartis Investigative Site, Paris

75701

East Texas Medical Center Cancer Institute, Tyler

76104

The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2), Fort Worth

80045

University of Colorado Dept. of Anschutz Cancer (2), Aurora

80132

Novartis Investigative Site, Napoli

83301

Novartis Investigative Site, Niaosong Township

84106

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

90095

University of California at Los Angeles Dept. of UCLA (3), Los Angeles

92637

Novartis Investigative Site, Weiden

35294-0006

University of Alabama at Birmingham/ Kirklin Clinic Comprehensive CancerCenter (1), Birmingham

92093-0658

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

06856

Norwalk Hospital Norwlak SC, Norwalk

20007-2197

Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Ctr (2, Washington D.C.

21237-3998

Weinberg Cancer Institute at Franklin Square Hospital, Baltimore

07601

Hackensack University Medical Center DeptofHackensackUniv.MedCtr., Hackensack

08043

Cooper Cancer Center, Voorhees Township

27599-7295

University of North Carolina Dept. of LinbergerCancerCtr(3), Chapel Hill

C1405BCH

Novartis Investigative Site, Caba

B1902CMK

Novartis Investigative Site, La Plata

S2002KDS

Novartis Investigative Site, Rosario

T4000IAK

Novartis Investigative Site, San Miguel de Tucumán

20230-130

Novartis Investigative Site, Rio de Janeiro

90610-000

Novartis Investigative Site, Porto Alegre

05403-000

Novartis Investigative Site, São Paulo

T2N 4N2

Novartis Investigative Site, Calgary

T6G 1Z2

Novartis Investigative Site, Edmonton

V5Z 4E6

Novartis Investigative Site, Vancouver

V8R 6V5

Novartis Investigative Site, Victoria

M4N 3M5

Novartis Investigative Site, Toronto

M5G 2M9

Novartis Investigative Site, Toronto

J4V 2H1

Novartis Investigative Site, Greenfield Park

H2X 3J4

Novartis Investigative Site, Montreal

S7N 4H4

Novartis Investigative Site, Saskatoon

DK-2730

Novartis Investigative Site, Herlev

Unknown

Novartis Investigative Site, Hong Kong

Novartis Investigative Site, Shatin, New Territories

6229 HX

Novartis Investigative Site, Maastricht

2545 CH

Novartis Investigative Site, The Hague

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

301-747

Novartis Investigative Site, Daejeon

03203

Novartis Investigative Site, Elche

08208

Novartis Investigative Site, Sabadell

BS2 8ED

Novartis Investigative Site, Bristol

SW3 6JJ

Novartis Investigative Site, London

NG5 1PB

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY