Doxo V1.1

• Research type

  Research Study

• Full title

  Phase II pharmacokinetic study to assess the age-dependency in the clearance of doxorubicin in paediatric patients with solid tumours and leukaemia - A European paediatric oncology off-patent medicines consortium protocol.

• IRAS ID

  35746

• Contact name

  Alan Boddy

• Sponsor organisation

  University Hospital Munster

• Eudract number

  2009-011454-17

• ISRCTN Number

  N/A

• Research summary

  Doxorubicin is widely used in the treatment of children's cancer, but little is known about how the rapidly the drug is metabolized and removed from the body, particularly in very young children. The study brings together investigators in the UK, in France, Germany and in Italy to investigate whether the rate of metabolism and removal is related to age or to the toxicity caused by treatment with doxorubicin. Because children's cancer is relatively rare, in order to recruit sufficient patients it is necessary to run the study in multiple clinical centres across 4 different countries. This study is funded by the FP7-programme of the European Union, specifically to obtain information on drugs like doxorubicin, where the drug is widely-used, but there are gaps in our knowledge.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  10/H0904/22

• Date of REC Opinion

  7 May 2010

• REC opinion

  Favourable Opinion