EP0042-101
Research type
Research Study
Full title
A Modular, Multipart, Multi-arm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of EP0042 Alone and in Combination with Anti-cancer Treatments in Patients with Advanced Malignancies
IRAS ID
275864
Contact name
David Taussig
Contact email
Sponsor organisation
Ellipses Pharma Limited
Eudract number
2020-000168-53
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Acute myeloid leukaemia (AML) is a blood cancer characterised by excessive production of abnormal white blood cells called blasts, in the blood and bone marrow. AML is a rare disease with one of the lowest survival rates and can lead to death within weeks if left untreated. Chemotherapy can be used to treat newly diagnosed AML, however most patients who achieve complete remission relapse within 1-3 years.
The study medication, EP0042, has been developed to treat AML by combining the activities of 2 established cancer treatment pathways called FLT3 inhibitor and Aurora kinase inhibitor. The FLT3 gene is involved in production and survival of leukaemia and other cancer cells. Aurora kinase is an enzyme involved in the division and multiplication of cells in different tumours. Both types of medicines have been given to patients with AML in other studies as separate drugs, but this study will investigate the combination of the 2 cancer treatments in 1 drug.
This is a first time in human study to test the effect of EP0042 alone and in combination with anti-cancer treatments in patients with advanced cancer. This study has a modular design which means different effects and interactions of the study drug will be evaluated in advanced cancers. The first module will investigate EP0042, in order to determine a dose, which is safe, tolerated and likely to be effective in treating AML. A total of 7 modules will be included, with the first module (Module 1) being detailed in the available protocol, future amendments will detail Modules 2-7.
The study will look at how people’s bodies respond to the study drug and what happens to the study drug as it moves through people’s bodies.REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0478
Date of REC Opinion
22 May 2020
REC opinion
Further Information Favourable Opinion