drugset / Trial / NCT00993512

Safety Study of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Cutaneous Cancer

NCT00993512

Phase 1 Completed 19 enrolled PCI Biotech AS
NaSingle-groupOpen-labelTreatment

Summary

This study is an open, non- randomized, phase I, dose-escalating study to evaluate the safety and tolerance of Amphinex based PCI of bleomycin in patients with local recurrent or advanced/metastatic, cutaneous or sub-cutaneous malignancies.

Timeline

Start
2009-08
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fimaporfin Other / unclassified 0.25 mg/kg Intravenous
Subject Fimaporfin Other / unclassified 0.5 mg/kg Intravenous
Subject Fimaporfin Other / unclassified 1 mg/kg Intravenous
Subject Fimaporfin Other / unclassified 1.5 mg/kg Intravenous
Background Bleomycin Unknown 15000 iu Intravenous