I-TRAC

• Research type

  Research Study

• Full title

  IGF-1R inhibition in the Treatment of RAS/RAF Mutant Advanced Colorectal Cancer: A Randomised Phase II study comparing FOLFIRI plus Dalotuzumab to FOLFIRI alone in patients with KRAS or BRAF mutant previously untreated advanced colorectal cancer (I-TRAC)

• IRAS ID

  46605

• Contact name

  David Cunningham

• Sponsor organisation

  Royal Marsden NHS Foundation Trust

• Eudract number

  2010-019682-28

• ISRCTN Number

  Not Submitted

• Research summary

  This is a randomised phase I/II open-label study of dalotuzumab, a targeted therapy, in combination with a standard chemotherapy (FOLFIR flurouracil and irinotecan) in patients with previously untreated advanced colorectal cancer who have a KRAS or BRAF mutation present in the tumour tissue. Dalotuzumab is an antibody which blocks the insulin-like growth factor receptor-a protein that's thought to be over-expressed in colorectal cancer. If the colorectal tumour contains KRAS or BRAF mutations, drugs such as cetuximab and panitumumab will not work however dalotuzumab has shown some promising early results in this type of colorectal cancer. The safety and efficacy of the drug will be assessed in the trial. Approximately 172 patients will be recruited to the study, which will be carried out at multiple centres across the United Kingdom.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/66

• Date of REC Opinion

  12 Oct 2010

• REC opinion

  Further Information Favourable Opinion