RecruitingPhase 2

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

France36 participantsStarted 2021-07-21

Plain-language summary

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.

Who can participate

Age range12 Years

SexALL

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Exclusion criteria

✕. No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months prior to enrolment;
✕. No history of AIDS-defining cancers (e.g. Kaposi's sarcoma, aggressive B-cell lymphoma and invasive cervical cancer);
✕. Subjects should be on established anti-retroviral therapy for at least 4 weeks and have an HIV viral load of \< 400 copies/mL prior to enrolment;

What they're measuring

Progression-Free Rate at 4 months (4m-PFR)

Timeframe: Up to 16 weeks after the date of regorafenib + BSC treatment initiation

Trial details

NCT IDNCT04698785

SponsorCentre Leon Berard

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-21

Contact for this trial

Julien GAUTIER

+33(0)426556829 julien.gautier@lyon.unicancer.fr

View on ClinicalTrials.gov More Bone Sarcoma trials