Amphinex based PCI study (PCI 101/06)

• Research type

  Research Study

• Full title

  An open, phase I, dose-escalating study to evaluate the safety and tolerance of Amphinex based Photochemical Internalisation (PCI) of bleomycin in patients with local recurrence or advanced/metastatic, cutaneous or sub-cutaneous malignancies.

• IRAS ID

  22054

• Eudract number

  2006-005106-30

• ISRCTN Number

  Unknown

• Research summary

  This is a study of the drug Amphinex. The aim of the study is to investigate the use of Amphinex given with the chemotherapy drug Bleomycin (a well known and approved anti cancer drug), and light therapy, a technique known as photochemical internalisation [PCI]). It is expected that this combination treatment will kill cancer cells, but it has not previously been tested in humans. The main aim of the study is to find out which dose of Amphinex will kill the most cancer cells with the fewest side effects when used for PCI. The chosen best dose can then be used in future studies with Amphinex. The study will also investigate whether Amphinex helps to boost the immune system (this will be done in Oslo subjects only).

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/24

• Date of REC Opinion

  11 Jun 2009

• REC opinion

  Further Information Favourable Opinion