A clinical trial testing a new treatment combination in patients with leukaemia launches through the Combinations Alliance, a joint initiative between Cancer Research UK and the Experimental Cancer Medicine Centres (ECMC) Network based at University of Birmingham.
Researchers want to discover whether AstraZeneca and MSD’s experimental medicine, selumetinib (AZD6244, ARRY-142886), can be effective in combination with dexamethasone, a treatment already used for several conditions including leukaemia.
Run by the Cancer Research UK Clinical Trials Unit based at the University of Birmingham, SeluDex is the first clinical trial to include both adults and children in the Combinations Alliance portfolio. This trial is planned to open in 23 centres throughout the UK and in 11 additional centres spanning six European countries, to help recruit an initial 42 patients.
The phase 1 trial will examine 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. It is the first trial to incorporate such an innovative design enabling both paediatric and adult patients to test this novel combination at the same time.
Researchers will investigate the most suitable dose of selumetinib in combination with dexamethasone. They will also gather some preliminary information on the effectiveness of the combined treatment.
Dexamethasone belongs to a group of drugs called glucocorticoids. These are important in the treatment of leukaemia because they can stimulate the death of cancer cells. Selumetinib works to inhibit enzymes called MEK 1/2 which are critical components of the so-called RAS-ERK pathway. This pathway is implicated in driving cancer growth and progression.
Professor Josef Vormoor, international clinical lead for the trial, said: '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.'
George Kirk, Global Medicines Leader for selumetinib at AstraZeneca, said: 'Through our strategic collaboration with MSD on developing selumetinib, we are delighted to continue the long-standing relationship with Cancer Research UK and in particular, to have the opportunity to explore how selumetinib could contribute to the treatment of ALL in this innovative trial.'
Dr Ian Walker, Cancer Research UK’s Director of Clinical Research, said: 'It’s hugely exciting to launch the first children’s trial through our Combinations Alliance. We think it’s important to support research into promising new combination therapies and provide more treatment options to both adults and children living with cancer.'
'The Combinations Alliance was established to enable partnerships between drug development companies and researchers to identify new combinations of drugs in the hope of improving treatments and saving more lives from cancer. This is the first time that we have been successful in establishing a novel trial design involving both adults and children and we hope that this treatment combination will help more patients with leukaemia.