SeluDex

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International phase I/II expansion trial of the MEK inhibitor selumetinib in combination with dexamethasone for the treatment of relapsed/refractory RAS-pathway mutated paediatric and adult Acute Lymphoblastic Leukaemia

Trial Overview and Summary

 
Chief Investigator: Dr Tobias Menne
Sponsor:  University of Birmingham
Funder: Cancer Research UK and AstraZeneca
Disease Site:  Acute Lymphoblastic Leukaemia (ALL)
Trial Type: Clinical Trial of an Investigational Medicinal Product
Status: Open
UKCRN Study ID: 33990
Open to New Sites?  Yes
Recruitment Start Date: 17-Apr-2018
Anticipated Recruitment End Date:  17-Apr-2020
CRCTU Trial Management Team:  Early Drug Development Team
Trial Email Adress: seludex@trials.bham.ac.uk

Trial Summary

This trial is to investigate the combination of selumetinib and dexamethasone in the treatment of relapsed/refractory acute lymphoblastic leukaemia (ALL) in both adults and children. The trial is specifically for patients who have an identified change (mutation) in a particular gene in their cancer’s DNA. Phase I is to find the most suitable dose of selumetinib to safely give with dexamethasone. Phase II will use this dose to find out how well the combination works.

Please note that the trials team cannot give individuals clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible. 

Trial Protocol

Please Note:
Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional or refer to CancerHelp website (see the link below).

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.

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