Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma

PHASE2CompletedINTERVENTIONAL
Enrollment

219

Participants

Timeline

Start Date

June 5, 2013

Primary Completion Date

September 16, 2020

Study Completion Date

September 16, 2020

Conditions
Sarcoma
Interventions
DRUG

Regorafenib

Regorafenib (160 mg/d) once daily for three weeks on / one week off plus Best Supportive Care (BSC)until progression (according to RECIST 1.1), intolerance or consent withdrawal.

DRUG

Placebo

Placebo plus BSC until progression (according to RECIST 1.1) or unacceptable toxicity. Patients who have received placebo may be offered open-label regorafenib (cross-over option) after objective tumor progression

Trial Locations (25)

1090

AKH-Wien, Vienna

4010

Krankenhaus der Barmherzigen Schwestern Linz, Linz

6020

Universitätsklinik für Innere Medizin I, Innsbruck

8036

Medizinische Universität Graz, Graz

13273

Institut Paoli Calmettes, Marseille

13354

Hôpital de La Timone, Marseille

14076

Centre François Baclesse, Caen

21079

Centre GF Leclercq, Dijon

25000

Hôpital St Jacques, Besançon

32052

Institut Claudius Regaud, Toulouse

33076

Institut Bergonié, Bordeaux

35042

Centre Eugène Marquis, Rennes

42270

Institut de Cancérologie Lucien Neuwirth (ICL), Saint-Priest-en-Jarez

44805

Centre René Gauducheau, Nantes

54519

Centre Alexis Vautrin, Vandœuvre-lès-Nancy

59020

Centre Oscar Lambret, Lille

69373

Centre Léon Bérard, Lyon

75005

Institut Curie, Paris

75010

Hôpital Saint Louis, Paris

75014

Hôpital Cochin, Paris

76038

Centre Henri Becquerel, Rouen

92210

Institut Curie - Hôpital René Huguenin, Saint-Cloud

94800

Institut Gustave Roussy, Villejuif

Unknown

LKH, Klagenfurt

06189

Centre Antoine Lacassagne, Nice

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Centre Oscar Lambret

OTHER