Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone,
intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue
metastatic CIC-rearranged sarcomas
Randomized, placebo-controlled, multicentric, phase II study -This is a double-blind
placebo-controlled trial, with 5 cohorts: cohort A: Osteosarcoma, cohort B: Ewing sarcoma,
cohort C: Chondrosarcoma, cohort D : chondroma, cohort E: CIC-rearranged sarcoma. Cohort A, B
and C will involve a total of 36 patients (24 Regorafenib + 12 placebo), cohort D a total of
24 evaluable patients (16 Regorafenib + 8 placebo) and cohort E will involve a total of 27
evaluable patients (18 Regorafenib + 9 placebo).
159 patients who meet the eligibility criteria will be randomly assigned in a 2:1 ratio to
the following treatment groups :
The Arm A:
Regorafenib (160 mg/d) once daily for the 3 weeks on / 1 week off plus Best Supportive Care
(BSC) until progression (according to RECIST 1.1), intolerance or withdrawal of consent .
Patients receiving regorafenib who experience disease progression and for whom in the
investigator opinion, treatment with regorafenib is providing clinical benefit, may continue
the treatment following consultation with the study coordinator and the sponsor.
The Arm B:
Placebo plus BSC until progression (according to RECIST V1.1) intolerance or withdrawal of
consent. Patients who have received placebo will receive open-label regorafenib after
objective tumor progression.
Patients will be stratified at randomization according to histology .
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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