SeluDex is the first clinical trial to be launched through the Combinations Alliance – a joint initiative between Cancer Research UK and the Experimental Cancer Medicine Centres (ECMC) Network – that will include both adults and children.
The study will be overseen by the Cancer Research UK Clinical Trials Unit based at the University of Birmingham, and is scheduled to open in 23 centres throughout the UK and in 11 additional centres in six European countries.
The Phase I trial will include both adults and children who have had a relapse of their acute lymphoblastic leukaemia (ALL) or refractory ALL, and who have a mutation in a gene involved in the RAS pathway.
Researchers are seeking to determine the optimal dose of MEK 1/2 inhibitor selumetinib when combined with the glucocorticoid dexamethasone, and also intend to collect initial data on the effectiveness of the combination.
“Although there are effective treatments for leukaemia, for some patients, the disease can return after they have been treated. If this combination is successful, it could give us an urgently needed new way to treat patients who have relapsed and have few treatment options left,” noted Professor Josef Vormoor, international clinical lead for the trial.