LY3295668 Erbumine in Patients with Relapsed/Refractory Neuroblastoma
Research type
Research Study
Full title
A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients with Relapsed/Refractory Neuroblastoma.
IRAS ID
265974
Contact name
Lisa Howell
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2019-001042-18
Duration of Study in the UK
5 years, 5 months, 27 days
Research summary
This study is investigating the use of a research drug LY3295668 erbumine in the treatment of Relapsed/Refractory Neuroblastoma (NB).
NB is a type of cancer that forms in certain types of nerve tissue. It is the most common childhood extracranial (outside the bony structure covering the brain) solid tumour and third most common childhood cancer. Considering other factors, patients older than 18 months of age are generally considered high-risk disease with overall chances of 5-year survival being 40% to 50%.
Available treatment, which may include observation, surgery, radiation, or chemotherapy, is based on the individual patient. In a study of patients suffering from repeatedly occurring or refractory (unmanageable by treatment) NB and treated with chemotherapies topotecan and cyclophosphamide, progression-free survival (PFS; when the disease does not get worse) time was significantly improved after 3 years of combination therapy use. Overall survival was not improved. Outcome from relapsed or resistant NB is dire. Researchers worldwide attempting to find better treatments.
Aurora Kinase A inhibition blocks the actions of a tumour driver known as N-MYC. N-MYC is known to be important in the formation, growth and treatment resistance of tumours and so far it has proved very difficult to target N-MYC driven tumours. LY3295668 is a highly selective AurA inhibitor that can be taken by mouth, and has been evaluated in adult patients in a Phase 1 study, showing promising results with safety and drug usage over time.Study JZHD is a Phase 1 study designed to understand the safety and use of LY3295668 over time in paediatric patients with recurrent/refractory NB, when given with and without chemotherapy. About 71 patients, between the ages of 2 to 21 years old, from the US, UK, France, Germany, Australia, Canada and Japan will be selected to take part, with 8 participants from the UK.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0744
Date of REC Opinion
1 Apr 2020
REC opinion
Further Information Favourable Opinion