New drug efficacy in ES has been disappointing in the last decades and no new drugs have been
successfully introduced up to now in front line treatment. Among the tested drugs, early
clinical data suggest that strategies using multi-targeted tyrosine kinase inhibitors (TKI)
with anti-angiogenic activities are among the most efficient and may be beneficial in the
treatment of patients with ES.
Several TKI have been and are currently being tested as single-agent in patients with
relapsed/refractory ES with encouraging results in phase II trials. Regorafenib has shown
promising activity in Ewing sarcoma relapse setting, Nevertheless, regorafenib has never been
combined with the intensive chemotherapy VDC/IE schedule and therefore this combination needs
to be evaluated in order to avoid dose reduction of the current standard treatment and hence
its efficacy.
The current clinical trial has been therefore designed to test the feasibility of regorafenib
with ES conventional chemotherapy. It consists of a phase Ib that will only recruit patients
with multi-metastatic (other than lungs/pleura only) ES, that present the highest unmet
medical need (2 year EFS: 33%, similar to patients with relapse/refractory ES).
Phase:
Phase 1
Details
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators:
Bayer Princess Maxima Center for Pediatric Oncology