Amphinex-based PCI of bleomycin (PCI/101/06 extension)

• Research type

  Research Study

• Full title

  An extension to the open, phase I, dose-escalating study (PCI 101/06) to evaluate the tolerability, efficacy and safety of Amphinex 0.125 mg/kg or lower in Amphinex-based Photochemical Internalisation (PCI) of bleomycin in patients with local recurrence or advanced/metastatic, cutaneous or sub-cutaneous malignancies.

• IRAS ID

  87890

• Contact name

  Colin Hopper

• Sponsor organisation

  PCI Biotech AS

• Eudract number

  2011-003750-80

• ISRCTN Number

  N/A

• Research summary

  This is a continuation of a first in man study of the drug Amphinex. The aim of the study is to investigate the use of Amphinex given with chemotherapy drug Bleomycin (a well-known and approved anticancer drug) and light therapy, a technique known as photochemical internalisation (PCI). The main aim of the study is to find out whether reduced doses of Amphinex will show comparable signs of efficacy whilst at the same time having fewer side effects.

• REC name

  London - South East Research Ethics Committee

• REC reference

  11/LO/1482

• Date of REC Opinion

  15 Nov 2011

• REC opinion

  Further Information Favourable Opinion