Northern Institute for Cancer Research

Early phase clinical trials in paediatrics

Early phase clinical trials in paediatrics


We are a clinical team working in conjunction with clinical academics and research staff. We are developing an early phase trial service for childhood cancer patients across the north of Britain.


Early phase trials for children and young people have historically been challenging. There have been some patients not cured by conventional therapy spread across a range of conditions. This has been compounded by a lack of financial incentive for sponsors to test therapies in this patient group.

More treatments are now becoming available but patient numbers remain low.


To counteract this we have established a network called INCLuDE. This includes all the Principal Treatment Centres in the North:

  • Newcastle
  • Glasgow
  • Edinburgh
  • Belfast
  • Aberdeen

The purpose of this network is to have a sufficient patient load to achieve trial recruitment. This makes us attractive as a region for trial sponsors to open studies.

The whole network covers a population of 10 million people, with an estimated 340 new cases of cancer in the 0-18 age range.

This development has resulted in increased trial availability and recruitment in Newcastle. Approximately half of the patients now travel from outside our region for trials.

Substantial infrastructure investment and increasing profile is enhancing our activity.


We are based within a Principal Treatment Centre at the Great North Children’s Hospital. This has the most comprehensive range of therapies for children and young people's cancer in the country.

Our location within the Newcastle upon Tyne Hospitals Trust means that supportive specialist paediatric services are readily available.

We also benefit from clinical trial support services developed by the larger adult Early Phase trials unit.

We work closely with the Newcastle Cancer Centre Pharmacology Group and our associated Children’s Cancer study groups to develop novel biological targets.

Clinical trials and translational studies

We've been designated a 'First in Child' centre. We're one of only 20 such centres in Europe.

As the First in Child centre for the Northern Network, we are the site for early phase paediatric studies as they come through the Innovative Therapies for Children’s cancer European Consortium.

This Consortium administers most of the early phase trials for children and young people's cancer.

Chief Investigator Josef Vormoor has developed the first ever CRUK combination Alliance trial for paediatric oncology. This is the SeluDex study, which will open across Europe.

We have partnered with Roche on their therapy pipeline. We've been early openers of their first two studies.

Newcastle is the highest UK recruiting site for the Merck Fosaprepitant study and the Eisai Lenvatinib study.


Vormoor B, Veal GJ, Griffin MJ, Boddy AV, Irving J, Minto L, Case M, Banerji U, Swales KE, Tall JR, Moore AS, Toguchi M, Acton G, Dyer K, Schwab C, Harrison CJ, Grainger JD, Lancaster D, Kearns P, Hargrave D, Vormoor J: A Phase I/II trial of AT9283, a selective inhibitor of aurora kinase in children with relapsed or refractory acute leukaemia: challenges to run early phase clinical trials for children with leukaemia. Ped Blood Cancer 2016 (In press)

Moreno L, Marshall LV, Pearson AD, Morland B, Elliott M, Campbell-Hewson Q, Makin G, Halford SE, Acton G, Ross P, Kazmi-Stokes S, Lock V, Rodriguez A, Lyons  JF, Boddy AV, Griffin MJ, Yule M, Hargrave D. A phase I trial of AT9283 (a selective inhibitor of aurora kinases) in children and adolescents with solid tumors: a Cancer Research UK study. Clin Cancer Res 2015 21: 267-273


Josef Vormoor
Quentin Campbell Hewson
Simon Bailey
Geoff Shenton
Britta Vormoor

Hina Johnstone
Lisa Price
Gail Forster
Geoff Bell