REGO-EWING: Phase Ib study of the combination of regorafenib with conventional chemotherapy for the treatment of newly diagnosed patients with multimetastatic Ewing Sarcoma

The effectiveness of new drugs in Ewing Sarcoma has been disappointing over prior decades and no new drugs have been successfully introduced into first-line treatment to date.

Early clinical data suggests that strategies using multi-target tyrosine kinase (TKI) inhibitors with anti-angiogenic activities are among the most effective and may be beneficial in the treatment of patients with Ewing Sarcoma. Regorafenib has shown promising activity in relapsed Ewing Sarcoma.

Nevertheless, Regorafenib has never been combined with the, now standard, intensive VDC/IE chemotherapy regimen.

REGO-EWING was designed to test the feasibility of regorafenib with conventional Ewing Sarcoma chemotherapy. It consists of a phase Ib that will only recruit patients with multi-metastatic (other than lungs/ pleura only) Ewing Sarcoma, that present the highest unmet medical need for prognosis.

Disease Stage – Newly Diagnosed

Patient Age Range – 2 – 50 years of age at time of diagnosis

Trial sponsors

• National – ANZCHOG
• International – Gustave Roussy