drugset / Trial / NCT04055220

Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas

NCT04055220

Recruiting 168 enrolled Centre Leon Berard
RandomizedParallel-groupSingle-blindTreatment

Summary

Randomized, non-comparative, multicentre exploratory phase II study. Two arms concerning patients with bone sarcoma after the first line therapy: in the first arm, patients will be treated with Regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be kept under surveillance (standard of care). Regardless of their study arm, all the patients will be followed up until end of the study. The comparison between these two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of Relapse-Free Survival improvement.

Timeline

Start
2020-03-03
Primary completion
2026-10-01
Completion
2026-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Regorafenib Small molecule 80 mg
Subject Regorafenib Small molecule 120 mg