Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

760

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

July 31, 2011

Study Completion Date

January 31, 2014

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Regorafenib (Stivarga, BAY73-4506)

160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

DRUG

Placebo

matching placebo tablets for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

OTHER

Best Supportive Care (BSC)

BSC includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.

Trial Locations (171)

1000

Bruxelles - Brussel

1070

Bruxelles - Brussel

1082

Budapest

1200

Bruxelles - Brussel

1211

Geneva

2065

St Leonards

2139

Concord

2650

Edegem

3000

Leuven

3011

Footscray

3050

Parkville

4032

Debrecen

4102

Woolloogabba

4400

Nyíregyháza

5011

Woodville South

6725

Szeged

7000

Chur

8800

Roeselare

10011

New York

13005

Marseille

13125

Berlin

16132

Genova

18081

Prague

18510

Scranton

20133

Milan

20162

Milan

25124

Brescia

26133

Oldenburg

28040

Madrid

28041

Madrid

28046

Madrid

29010

Málaga

29150

Sumter

29414

Charleston

30625

Hanover

32224

Jacksonville

32457

Porta Westfalica

33180

Aventura

34298

Montpellier

34390

Istanbul

34662

Instanbul

35042

Rennes

35100

Izmir

39104

Magdeburg

41013

Seville

41124

Modena

42100

Reggio Emilia

43623

Toledo

45122

Essen

48106

Ann Arbor

50924

Cologne

51092

Reims

51375

Leverkusen

52403

Cedar Rapids

54290

Trier

54303

Green Bay

55905

Rochester

56126

Pisa

56303

Saint Cloud

58122

Fargo

59020

Lille

59037

Lille

65109

Jefferson City

67085

Strasbourg

68167

Mannheim

70121

New Orleans

70199

Stuttgart

72015

Le Mans

75651

Paris

76137

Karlsruhe

79106

Freiburg im Breisgau

80131

Napoli

81377

München

81737

München

81925

München

84000

Avignon

84106

Salt Lake City

90033

Los Angeles

90036

Los Angeles

90211

Beverly Hills

91345

Mission Hills

92374

Redlands

92868

Orange

93454

Santa Maria

100021

Beijing

100071

Beijing

130021

Changchun

150040

Ha’erbin

200001

Shanghai

200030

Shanghai

210003

Nanjing

210009

Nanjing

266100

Qingdao

300060

Tianjin

310009

Hanghzou

350014

Fuzhou

350025

Fuzhou

400038

Chongqing

400042

Chongqing

510060

Guangzhou

510515

Guangzhou

3109601

Haifa

4941492

Petah Tikva

5262000

Tel Litwinsky

6093000

Zrifin

6423906

Tel Aviv

7610001

Rehovot

7830604

Ashkelon

8410101

Beersheba

9112001

Jerusalem

61615-7828

Peoria

07754

Neptune City

75390-9110

Dallas

C1122AAL

Buenos Aires

C1264AAA

Buenos Aires

S2000PBJ

Rosario

T4000GTB

San Miguel de Tucumán

C1426ANZ

Capital Federal-Buenos Aires

60160-230

Fortaleza

41830-492

Salvador

30110-090

Belo Horizonte

98700-000

Ijuí

V5Z 4E6

Vancouver

R2H 2A6

Winnipeg

E1C 6Z8

Moncton

N6A 4L6

London

L5M 2N1

Mississauga

L1G 2B9

Oshawa

M4N 3M5

Toronto

H3T 1E2

Montreal

G1R 2J6

Québec

65 653

Brno

500 05

Hradec Králové

775 20

Olomouc

01307

Dresden

06120

Halle

Unknown

Holon

00168

Roma

464-8681

Nagoya

260-8717

Chiba

277-8577

Kashiwa

791-0280

Matsuyama

812-8582

Fukuoka

060-8648

Sapporo

781-8555

Kochi

860-8556

Kumamoto

540-0006

Osaka

589-8511

Sayama

569-8686

Takatsuki

350-1298

Hidaka

362-0806

Kita-Adachigun

411-8777

Sunto

329-0498

Shimotsuke

320-0834

Utsunomiya

113-8519

Bunkyo-ku

104-0045

Chuo-ku

135-8550

Koto-ku

181-8611

Mitaka

1081 HV

Amsterdam

2134 TM

Hoofddorp

8901 BR

Leeuwarden

2333 ZA

Leiden

3810-096

Aveiro

4099-001

Porto

4200-072

Porto

3030-075

Coimbra

1649-035

Lisbon

08035

Barcelona

08907

L'Hospitalet de Llobregat

08208

Sabadell

06500

Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY