Trial of Figitumumab in children with relapsed/refractory solid tumour

• Research type

  Research Study

• Full title

  A phase I trial of Figitumamab, an IGFR-1R antibody, in children aged 1-12 years old with relapsed/refractory solid tumours - FOREST Study

• IRAS ID

  43994

• Contact name

  Kathy Pritchard-Jones

• Eudract number

  2010-018373-38

• ISRCTN Number

  12655440

• Research summary

  Solid tumours of childhood comprise approximately two thirds of all childhood cancer this equates to over 8,000 newly diagnosed children in Europe each year. While the overall survival is approaching 75%, there are several diagnostic subgroups where there is little or no improvement in survival achieved despite intensive, risk adapted front line use of currently available treatment strategies and other where survival remain <50%. Novel approaches to treatment are needed, as dose intensification and use of multimodality therapies have reached their limits. The investigational agent is an antibody that blocks the insulin like growth factor 1 receptor, a signalling pathway that's activated in several cancers that affects young children. This is a dose escalation study designed to evaluate the safety and establish a safe dose for the drug figitumamab in children aged 1-12 years with relapsed or refractory solid tumours. Figitumamab is given on day 1 of a three week cycle and patient can receive up to 12 cycles providing there is clinical benefit. It is given as an IV infusion over 2.5 hours. There are 4 dose levels the starting dose is 6mg/kg, escalating to 10, 20, 30mg/kg. During the first cycle only a second identical loading dose will be given on day 2. The treatment can be given within a day care setting although an overnight admission recommended for cycle 1.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/96

• Date of REC Opinion

  17 Dec 2010

• REC opinion

  Further Information Favourable Opinion