Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

365

Participants

Timeline

Start Date

November 12, 2008

Primary Completion Date

December 31, 2011

Study Completion Date

April 15, 2013

Conditions
CarcinomaAdenocarcinomaRenal CellNephroid CarcinomaHypernephroid
Interventions
DRUG

RAD001(everolimus)

10 mg qd

DRUG

interferon alfa-2a

dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3

DRUG

bevacizumab

10 mg/kg every 2 weeks

Trial Locations (109)

112

Novartis Investigative Site, Taipei

114

Novartis Investigative Site, Taipei

1070

Novartis Investigative Site, Brussels

1086

Novartis Investigative Site, Budapest

1122

Novartis Investigative Site, Budapest

1200

Novartis Investigative Site, Brussels

2196

Novartis Investigative Site, Johannesburg

3000

Novartis Investigative Site, Leuven

3010

Novartis Investigative Site, Bern

4000

Novartis Investigative Site, Liège

6000

Novartis Investigative Site, Charleroi

7000

Novartis Investigative Site, Chur

8500

Novartis Investigative Site, Kortrijk

10002

Novartis Investigative Site, Taipei

10117

Novartis Investigative Site, Berlin

10330

Novartis Investigative Site, Bangkok

13055

Novartis Investigative Site, Berlin

14021

Novartis Investigative Site, Caen

16059

Novartis Investigative Site, Bursa

20133

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

23007

Novartis Investigative Site, Jaén

25123

Novartis Investigative Site, Brescia

26100

Novartis Investigative Site, Cremona

27100

Novartis Investigative Site, Pavia

28034

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

30625

Novartis Investigative Site, Hanover

31059

Novartis Investigative Site, Toulouse

33075

Novartis Investigative Site, Bordeaux

33081

Novartis Investigative Site, Aviano

33305

Novartis Investigative Site, Linkou District

34298

Novartis Investigative Site, Montellier Cedex 5

34394

Novartis Investigative Site, Mecidiyekoy/Istanbul

34662

Novartis Investigative Site, Altunizade

35340

Novartis Investigative Site, Balcova / Izmir

37024

Novartis Investigative Site, Negrar

37075

Novartis Investigative Site, Göttingen

38100

Novartis Investigative Site, Trento

39008

Novartis Investigative Site, Santander

Novartis Investigative Site, Santander

40705

Novartis Investigative Site, Taichung

41100

Novartis Investigative Site, Modena

44202

Novartis Investigative Site, Nantes

45122

Novartis Investigative Site, Essen

48201

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

50009

Novartis Investigative Site, Zaragoza

50134

Novartis Investigative Site, Florence

51100

Novartis Investigative Site, Reims

55131

Novartis Investigative Site, Mainz

60488

Novartis Investigative Site, Frankfurt

60590

Novartis Investigative Site, Frankfurt

67010

Novartis Investigative Site, Strasbourg

67091

Novartis Investigative Site, Strasbourg

69115

Novartis Investigative Site, Heidelberg

72076

Novartis Investigative Site, Tübingen

72703

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville

75038

Las Colinas Hematology Oncology Grapevine, Irving

76031

Novartis Investigative Site, Rouen

80131

Novartis Investigative Site, Napoli

84000

Novartis Investigative Site, Avignon

85925

Novartis Investigative Site, La Roche-sur-Yon

88100

Novartis Investigative Site, Catanzaro

89135

Nevada Cancer Institute Dept. of Nevada Cancer (3), Las Vegas

90053

USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3, Los Angeles

90095

University of California at Los Angeles Dept. of Hem/Oncology, Los Angeles

90110

Novartis Investigative Site, Songkhla

92150

Novartis Investigative Site, Suresnes

98105

Seattle Cancer Care Alliance Dept. of SCCA, Seattle

115478

Novartis Investigative Site, Moscow

125284

Novartis Investigative Site, Moscow

191104

Novartis Investigative Site, Saint Petersburg

197758

Novartis Investigative Site, Saint Petersburg

249036

Novartis Investigative Site, Obninsk

258500

Novartis Investigative Site, Singapore

91010-3000

City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3), Duarte

Unknown

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

Novartis Investigative Site, Cairo

Novartis Investigative Site, Cairo

Novartis Investigative Site, Shatin, New Territories

Novartis Investigative Site, Tuenmen

20230-130

Novartis Investigative Site, Rio de Janeiro

90560-030

Novartis Investigative Site, Porto Alegre

90610-000

Novartis Investigative Site, Porto Alegre

14015-130

Novartis Investigative Site, Ribeirão Preto

09060-650

Novartis Investigative Site, Santo André

01246-000

Novartis Investigative Site, São Paulo

775 20

Novartis Investigative Site, Olomouc

140 00

Novartis Investigative Site, Prague

06846

Novartis Investigative Site, Dessau

04109

Novartis Investigative Site, Leipzig

06129

Novartis Investigative Site, Perugia

00128

Novartis Investigative Site, Roma

00152

Novartis Investigative Site, Roma

2333 ZA

Novartis Investigative Site, Leiden

0001

Novartis Investigative Site, Pretoria

0044

Novartis Investigative Site, Pretoria

03722

Novartis Investigative Site, Goyang-si

06351

Novartis Investigative Site, Seoul

705-703

Novartis Investigative Site, Daegu

136-705

Novartis Investigative Site, Seoul

700 -721

Novartis Investigative Site, Taegu

08041

Novartis Investigative Site, Barcelona

01330

Novartis Investigative Site, Adana

06100

Novartis Investigative Site, Ankara

07070

Novartis Investigative Site, Antalya

HA6 2RN

Novartis Investigative Site, Northwood

G12 0YN

Novartis Investigative Site, Glasgow

SO16 6YD

Novartis Investigative Site, Southampton

Sponsors
All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Novartis Pharmaceuticals

INDUSTRY