ARC-II in locally advanced pancreatic carcinoma

• Research type

  Research Study

• Full title

  A Phase II study in patients with locally advanced pancreatic carcinoma: ARC-II – Akt-inhibition by Nelfinavir plus chemoradiation with gemcitabine and cisplatin

• IRAS ID

  4736

• Sponsor organisation

  The University of Oxford

• Eudract number

  2008-006302-42

• ISRCTN Number

  N/A

• Research summary

  The 5-year survival rate of patients with pancreatic carcinoma is only 1-4%. One of the factors in this is the current lack of effective therapy. Unusual expression of genes that share a common signalling pathway are known. One such pathway is the phosphatidylinositol 3-kinase (PI3K)-Akt pathway. It has been shown that blockage of Akt (a protein within the cell) can assist the response to radiation in vitro and in vivo. Since this signalling pathway is often activated in tumour cells but not host cells it is a good target candidate to block to increase the sensitivity to radiotherapy. A set of drugs in common practice for HIV therapy (HIV protease inhibitors) block this pathway, one such drug is Nelfinavir. We propose to use Nelfinavir in combination with the current standard care of chemoradiation (radiotherapy, gemcitabine and cisplatin) to investigate its effect in the treatment of pancreatic carcinoma. A successful phase 1 study (12 patients) of this regime carried out by Dr Brunner has initiated the request for this UK phase II study funded by the NIHR Oxford Biomedical Research Centre.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/36

• Date of REC Opinion

  13 May 2009

• REC opinion

  Further Information Favourable Opinion