Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)

PHASE3CompletedINTERVENTIONAL
Enrollment

199

Participants

Timeline

Start Date

January 4, 2011

Primary Completion Date

January 26, 2012

Study Completion Date

April 15, 2019

Conditions
Gastrointestinal Stromal Tumors
Interventions
DRUG

Regorafenib (Stivarga, BAY73-4506)

160 mg po once daily (od), 3 weeks on/1 week off. Route of administration: oral

DRUG

Placebo

once daily (od), 3 weeks on/1 week off. Route of administration: oral

DRUG

Best supportive care

Best supportive care includes any method to preserve the comfort and dignity of the patients, and excludes any disease-specific anti-neoplastic therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgical intervention.

Trial Locations (57)

1090

Vienna

3000

Leuven

6020

Innsbruck

8036

Graz

10060

Turin

10065

New York

15526

Bad Saarow

20133

Milan

30625

Hanover

33076

Bordeaux

40138

Bologna

40479

Düsseldorf

45122

Essen

49201

Busan

50924

Cologne

55455

Minneapolis

59020

Lille

60076

Skokie

60201

Evanston

64239

Tel Aviv

68167

Mannheim

69373

Lyon

72076

Tübingen

85258

Scottsdale

90127

Palermo

94805

Villejuif

98109

Seattle

100071

Beijing

169610

Singapore

200030

Shanghai

210002

Nanjing

510060

Guangzhou

02115

Boston

97239-2964

Portland

19111-2497

Philadelphia

T6G 1Z2

Edmonton

N6A 4L6

London

M5G 1X5

Toronto

00290

Helsinki

466-8650

Nagoya

277-8577

Kashiwa

060-8648

Sapporo

104-0045

Chuo-ku

951-8520

Niigata

543-0035

Osaka

2333 ZA

Leiden

6525 GA

Nijmegen

02-781

Warsaw

410-769

Goyang-si

03080

Seoul

06351

Seoul

138-736

Seoul

08907

L'Hospitalet de Llobregat

08035

Barcelona

LE1 5WW

Leicester

SW3 6JJ

London

M20 4BX

Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01271712 - Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST) | Biotech Hunter | Biotech Hunter