LINES: Eurosarc Trial of Linsitinib in advanced Ewing Sarcoma
Research type
Research Study
Full title
Phase II trial of Linsitinib (anti-IGFR/IR) in patients with relapsed and/or refractory Ewing Sarcoma
IRAS ID
118359
Contact name
Andrew Bassim Hassan
Contact email
Sponsor organisation
University of Oxford
Eudract number
2012-000616-28
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Ewing Sarcoma (ES) is the second most common bone cancer in children and young adults. It has a predicted 60-70% 5 year survival using conventional chemotherapy, radiotherapy and high dose chemotherapy. Survival for the 25% of patients that present with metastatic disease is approximately 20% and for those who develop relapsed and refractory disease, the survival is no more that 10%.
An important development in Ewing Sarcoma has been the identification of the Insulin-like Growth Factor 1 Receptor (IGF-1R) pathway dependency. A number of Phase I/II studies in the paediatric and adult populations have shown that a subset of ES patients (10-30%) respond to antibodies targeted to this pathway.
In this trial we will be treating patients aged 18+ who have relapsed and/or refractory Ewing Sarcoma with the unlicensed drug linsitinib. Linsitinib is a small molecule inhibitor of this IGF-1R pathway as well as the Insulin receptor pathway. Patients will be recruited from the national bone sarcoma centre in 5 EU countries. Patients may receive trial treatment for as long as they gain clinical benefit and it is safe for them to do so.
We will evaluate the response rate, tolerability and tissue biomarker responses following single agent linsitinib treatment utilising adaptive Bayesian analysis. These data will inform the design of future combination studies with other agents.
The trial is funded by the EU FP7 Eurosarc grant for research into rare sarcomas.REC name
South Central - Oxford C Research Ethics Committee
REC reference
13/SC/0330
Date of REC Opinion
22 Aug 2013
REC opinion
Further Information Favourable Opinion