REGO-INTER-EWING-1

Last Updated | 21 April 2026

REGO-INTER-EWING-1

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

Trial Summary

This study is for patients with newly diagnosed Ewing Sarcoma that has spread. It tests a new targeted drug called regorafenib alongside standard chemotherapy. Regorafenib works by blocking the growth of new blood vessels that tumours need to grow. The study aims to see if adding this drug to the usual treatment is safe and if it can help more patients survive this aggressive bone and soft tissue cancer.

A Phase Ib Study evaluating the feasibility and safety of regorafenib (a multi-kinase inhibitor) combined with conventional chemotherapy in patients with newly diagnosed mulit-metastatic Ewing Sarcoma. It aims to determine if the addition of Regorafinib can enhance the efficacy of therapy in this high-risk population. The trial consists of a phase Ib dose finding escalation, to determine the recommended Phase 2 dose (RP2D) of Regorafenib. The dose-finding escalation will be driven by the occurrence of Dose-Limiting Toxicities (DLT). Secondary objectives indlued assessment of overall survival and therapy response.

Site Status

Queensland Children's Hospital (QLD)

John Hunter Children's Hospital (NSW)

Sydney Children's Hospital (NSW)

Monash Health Clayton (VIC)

Royal Children's Hospital (VIC)

Women's and Children's Hospital (SA)

Perth Children's Hospital (WA)

Royal Hobart Hospital (TAS)

Children's Hospital at Westmead (NSW)

Starship Children's Hospital (NZ)

Christchurch Hospital (NZ)

Preparing to Open

Open

Temporarily Closed

Closed

Complete

Adult Sites These sites are not monitored. Status may vary.

Diagnosis Stage Newly Diagnosed

Open Date 27/03/2023

Conditions Multimetastatic Ewing Sarcoma

Patient Range 2 years50 years

Disease Type Soft Tissue and Bone Tumours (Sarcoma)

Study Type Interventional

Funders

ANZCHOG acknowledges the valuable support of REGO-INTER-EWING-1 by:

The Australian Organisation For Young People Living With Cancer, Charity (Canteen), Australian Government’s Medical Research Future Fund, The Kids Cancer Project, Australia and New Zealand Sarcoma Association

Last Updated | 21 April 2026