Phase II Study of Regorafenib as Maintenance Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

May 15, 2019

Primary Completion Date

March 15, 2024

Study Completion Date

September 26, 2024

Conditions
Metastatic Soft Tissue Sarcoma
Interventions
DRUG

Regorafenib

"Oral Drug in the form of 40 mg tablets - Regorafenib (120 mg/d) once daily for 3 weeks on / 1 week off plus Best Supportive Care (BSC) until progression (according to RECIST 1.1), intolerance or consent withdrawal.~Provided by BAYER"

DRUG

Placebo

"Oral tablets - 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~Provided by BAYER"

Trial Locations (20)

13005

Hôpital La Timone, Marseille

13273

Institut Paoli-Calmettes, Marseille

14076

Centre François Baclesse, Caen

21079

Centre Georges-François LECLERC, Dijon

25000

CHRU Besançon, Besançon

31059

Institut Claudius Regaud, Toulouse

33076

Institut Bergonié, Bordeaux

34298

Institut régional du Cancer de Montpellier, Montpellier

35042

Centre Eugène Marquis, Rennes

42270

Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez

44805

Centre René Gauducheau, Nantes

51100

Institut Godinot, Reims

59020

Centre Oscar Lambret, Lille

67000

Hôpitaux universitaires de Strasbourg, Strasbourg

69373

Centre Léon Bérard, Lyon

75005

Institut Curie, Paris

76038

Centre Henri Becquerel, Rouen

86000

Chu Poitiers, Poitiers

94805

Institut Gustave Roussy, Villejuif

06189

Centre Antoine Lacassagne, Nice

All Listed Sponsors
lead

Centre Oscar Lambret

OTHER

NCT03793361 - Phase II Study of Regorafenib as Maintenance Therapy | Biotech Hunter | Biotech Hunter