drugset / Trial / NCT01872923

Dose Escalating Study for Amphinex-based PCI of Bleomycin.

NCT01872923

Phase 1 Completed 3 enrolled PCI Biotech AS
NaSingle-groupOpen-labelTreatment

Summary

The primary goal of this extension study is to further investigate the tolerability and efficacy in a phase I setting in order to see whether lower doses than the initial study dose of 0.25 mg/kg bw Amphinex in Amphinex-based PCI of bleomycin will show a comparable or improved safety and tolerability profile in combination with comparable signs of efficacy.

Timeline

Start
2012-01
Primary completion
2012-10
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bleomycin Unknown
Subject Fimaporfin Other / unclassified 0.125 mg/kg

Indications