Phase I, Dose-escalating Study to Evaluate Safety and Tolerance of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Local Recurrence or Advanced/Metastatic, Cutaneous or Sub-cutaneous Malignancies
Sponsor study identifier
interventional
19
1 country
1
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 9, 2009
Actual (reported)October 12, 2009
Actual (reported)May 2011
Actual (reported)May 2011
Actual (reported)Dose limiting toxicity
28 days
Tumour response according to Response Evaluation Criteria in Solid Tumors (RECIST)
3 months
No comparative treatment is given in this open-label phase I, dose escalating safety study
intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.
intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.
University College London Hospital
London, NW1 2PG, United Kingdom
Sultan AA, Jerjes W, Berg K, Hogset A, Mosse CA, Hamoudi R, Hamdoon Z, Simeon C, Carnell D, Forster M, Hopper C. Disulfonated tetraphenyl chlorin (TPCS2a)-induced photochemical internalisation of bleomycin in patients with solid malignancies: a phase 1, dose-escalation, first-in-man trial. Lancet Oncol. 2016 Sep;17(9):1217-29. doi: 10.1016/S1470-2045(16)30224-8. Epub 2016 Jul 28.
Colin Hopper, MD
University College London Hospitals
19 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2009
First Posted
October 12, 2009
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck
intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
April 29, 2019
Record last verified: 2019-04
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Source: ClinicalTrials.gov.
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