NCT01872923

Dose Escalating Study for Amphinex-based PCI of Bleomycin.

Dose Escalating Study to Evaluate the Tolerability, Efficacy and Safety of Amphinex 0.125 mg/kg or Lower in Amphinex-based PCI of Bleomycin in Patients With Local Recurrence or Advanced/Metastatic, Cutaneous or Sub-cutaneous Malignancies.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: PCI Biotech AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Use of Amphinex for the enhancement of Bleomycin at the intracellular target. The photosensitizer Amphinex is activated by Laser Light at 652 nm. Superficial lesions (cutaneous or subcutaneous) was treated with the laser light after administration of Amphinex and Bleomycin according to time scheduled provided. Safety and preliminary effect data where evaluated at a lower dose than explored in the preceeding dose escalating study with Amphinex.

Conditions

• Cutaneous or Sub-cutaneous Malignancies

Interventions

Type	Name	Description
DRUG	Amphinex	Photosensitiser
DRUG	Bleomycin	Anticancer agent
DEVICE	Laser	Laser that emits red light at 652 nm.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-10-01
• Completion: 2013-02-01
• First posted: 2013-06-07
• Last updated: 2014-06-16

Locations

1 site across 1 country: United Kingdom