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.
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
3
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
February 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 2012
Actual (reported)February 2013
Actual (reported)May 27, 2013
Actual (reported)June 7, 2013
Actual (reported)To assess the combined tolerability and efficacy of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin
Maximal pain during the procedure will be recorded immediately after the procedure on a 10 centimetre visual analogue scale (VAS). Pain will also be recorded 24 hours after the illumination and on day 4. The end-points of the VAS will be "no pain" and "unbearable pain A formal efficacy analysis is not appropriate for this trial. The response data will be documented by descriptive summary tables. No statistical comparison of dose levels will be done. Fluorescence measurements over time and lesion response evaluation according to RECIST (see Appendix E) will be presented for APT and PP stratified by dose level.
From Baseline to 3 months
To evaluate the safety of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin.
From Baseline to 3 months
The photosensitiser Amphinex is activated by Laser to enhance the effect of Bleomycin
Photosensitiser
Anticancer agent
University College London Hospital
London, United Kingdom
Martin Forster, MD
University College London Hospitals
3 participants (actual enrollment reported by the registry).
First Submitted
May 27, 2013
First Posted
June 7, 2013
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Feasibility of imILT Locally Advanced Pancreatic Cancer (LAPC)
To determine the pharmacokinetics of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin.
From Baseline to 3 months
Laser that emits red light at 652 nm.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
February 2013
Actual (reported)Last Updated
June 16, 2014
Record last verified: 2014-06
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Source: ClinicalTrials.gov.
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