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 groupSponsors and collaborators
Source ClinicalTrials.gov