Efficacy of Regorafenib Combined With Best Supportive Care as Maintenance Treatment in High Grade Bone Sarcomas Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorCentre Leon Berard

About this trial

This is a multicenter phase II study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or at relapse.

Patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion.

Progression free rate (PFR) data will be collected and analysed for all included patients to evaluate if regorafenib + BSC can be considered as an interesting treatment for further investigations in this indication.

Eligibility criteria

Qualifiers

None

Disqualifiers

Left ventricular ejection fraction (LVEF) < 50%,

Congestive heart failure ≥ New York Heart Association (NYHA) class 2,

Myocardial infarction < 6 months prior to first study drug administration,

Cardiac arrhythmias requiring therapy (beta blockers or digoxin are permitted),

Trial design

Treatments tested in this trial

  • Treatment by regorafenib and best supportive care

Treatment groups

36 Participants
are divided into 1 treatment group

Locations

16
Chu Besancon25030, Besançon France
Institut Bergonie33076, Bordeaux France
Centre Georges Francois Leclerc21079, Dijon France
Centre Oscar Lambret59020, Lille France

Sponsors and collaborators

Centre Leon Berard

Lead sponsor