# REGOBONE

Source: https://onco.cc/trials/regobone/  
OnCo record `regobone` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

REGOBONE showed that the tablet regorafenib delayed progression of osteosarcoma that had come back after chemotherapy, giving one of the few randomised results in relapsed bone cancer.

## Summary

REGOBONE was a French placebo-controlled randomised phase 2 trial run as parallel cohorts by histology in patients aged 10 or older with metastatic bone sarcoma progressing after standard chemotherapy. Patients received regorafenib, a multikinase inhibitor, or placebo with crossover allowed at progression. The primary endpoint was progression-free survival at eight weeks in the osteosarcoma cohort.

The osteosarcoma cohort met its endpoint, with more patients progression-free at eight weeks and longer median progression-free survival on regorafenib, matching the American SARC024 trial reported at the same time. The Ewing sarcoma cohort also favoured regorafenib, and the chondrosarcoma cohort suggested activity in conventional and dedifferentiated tumours; chordoma results were reported separately. Regorafenib is used at relapse on this evidence though it has no formal approval in bone sarcoma.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT02389244
- Phase: 2
- Setting: Metastatic bone sarcomas after standard chemotherapy: regorafenib against placebo in separate cohorts for osteosarcoma, Ewing sarcoma, chondrosarcoma and chordoma
- Sponsor: UNICANCER
- Enrolled: 163
- Result: Regorafenib improved eight-week progression-free survival over placebo in relapsed osteosarcoma, with signals in the Ewing sarcoma and chondrosarcoma cohorts.

## Sources

- ClinicalTrials.gov NCT02389244: https://clinicaltrials.gov/study/NCT02389244

## Connected records

- cancers: [Chondrosarcoma](https://onco.cc/cancers/chondrosarcoma/), [Chordoma](https://onco.cc/cancers/chordoma/), [Ewing sarcoma](https://onco.cc/cancers/ewing-sarcoma/), [Osteosarcoma](https://onco.cc/cancers/osteosarcoma/), [Sarcomas (soft tissue, bone, GIST)](https://onco.cc/cancers/sarcoma/)
- drugs: [Regorafenib](https://onco.cc/drugs/regorafenib/)
- companies: [Bayer](https://onco.cc/companies/bayer/)
- people: [Florence Duffaud](https://onco.cc/people/florence-duffaud/)

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JSON: https://onco.cc/api/v1/entities/regobone.json