Cutaneous or Sub-cutaneous MalignanciesPhase 1NCT01872923
Dose Escalating Study for Amphinex-based PCI of Bleomycin.
A Phase 1 study testing Amphinex, Bleomycin and Laser in people with Cutaneous or Sub-cutaneous Malignancies, run by PCI Biotech AS at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous or Sub-cutaneous Malignancies
- What is being tested?
- Amphinex, Bleomycin and Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Feb 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Male or female aged 18 years or above who have given written informed consent
- Skin type I- IV according to the Fitzpatrick skin classification (see Appendix G)
- With a diagnosis of local recurrence or advanced/metastatic, cutaneous or subcutaneous malignancy
- Lesion measurement must not be done more than 2 weeks before the beginning of treatment. More than one field with lesion can be illuminated, but care must be taken to avoid overlap of the fields illuminated
- Have discontinued any other investigational therapy or radiotherapy for at least 2 weeks prior to administration of Amphinex at the baseline visit, and have recovered from the acute effects of therapy
- Have discontinued cytostatic or cytotoxic therapies with at least 6 half life cycles of the agent prior to administration of Amphinex at the baseline visit
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- Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (see Appendix D)
- Clinically assessed as eligible for bleomycin chemotherapy
- Have a predicted life expectancy of at least 3 months
- Geographic proximity that allow adequate follow-up
- If female: have had childbearing potential either terminated by surgery, radiation, or menopause or attenuated by the use of an approved contraceptive method during and for 3 months after the trial
- If male: have had reproductive potential either terminated or attenuated by the use of an approved contraceptive method during and for 3 months after the trial.
Who cannot join
- Have received prior PCI
- Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
- Planned surgery in first 28 days after treatment, except for planned surgical removal of the treated lesion
- Planned dentist appointments in first 28 days after treatment
- Anticancer therapy within the first 28 days after treatment
- Therapy with drugs that induce light sensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea, hypoglycemic agents, thiazide diuretics, and griseofulvin) within the first 14 days after treatment
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- Co-existing ophthalmic disease likely to require slit-lamp examination within the first 28 days after treatment
- History of hypersensitivity/anaphylactic reactions
- Previous cumulative dose of Bleomycin received over 200 000 IE
- Known allergy or sensitivity to photosensitisers
- Known allergy to Cremophor
- Known allergy to bleomycin
- Conditions contraindicated for bleomycin treatment (lung infection, impaired pulmonary function)
- Conditions that worsen when exposed to light (including porphyria)
- Conditions associated with a risk of poor protocol compliance
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the 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
- Being tested
- Amphinex, Bleomycin, Laser
- Keywords
- Amphinex, PCI, Bleomycin, Cutaneous malignancies, Sub-cutaneous malignancies, Safety, Phase I, Photochemical Internalisation, Squamous Cell Carcinoma, Head and Neck cancer, Breast Cancer, HNSCC, SCCHN, Advanced or metastatic cancer, Dose finding
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms, Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmphinexDrug
Photosensitiser
BleomycinDrug
Anticancer agent
LaserDevice
Also called Ceralas PDT 652+/-3nm 2W" by CeramOptec GmbH CE0297
Laser that emits red light at 652 nm.
| Study group | Role | What they receive |
|---|---|---|
| Amphinex based PCI of bleomycin | Experimental | The photosensitiser Amphinex is activated by Laser to enhance the effect of Bleomycin Receives: Drug: Amphinex; Drug: Bleomycin; Device: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to 3 months
Secondary outcomes (1)
To evaluate the safety of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin.
- Summaries of the adverse event rates and laboratory changes from baseline stratified by dose level.
- Listings and frequency tables categorizing laboratory and non-laboratory adverse events by maximum CTCAE toxicity grade and relationship to study drug.
- Pain measurement, fluorescence measurement, skin photosensitivity measurement
Measured: From Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous or Sub-cutaneous MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- PCI Biotech AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Forster, MD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872923
- Sponsor's protocol ID
- PCI 101/06 Extension
- Other IDs
- 2011-003750-80
- Status last verified
- Jun 2014
- First submitted
- 27 May 2013
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01872923
- Acronym / sponsor ID
- PCI 101/06 Extension
- Conditions
- Cutaneous or Sub-cutaneous Malignancies
- Keywords
- Amphinex, PCI, Bleomycin, Cutaneous malignancies, Sub-cutaneous malignancies, Safety, Phase I, Photochemical Internalisation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- PCI Biotech ASIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amphinex based PCI of bleomycin | Experimental | Drug: Amphinex, Drug: Bleomycin, Device: LaserThe photosensitiser Amphinex is activated by Laser to enhance the effect of Bleomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- • Male or female aged 18 years or above who have given written informed consent
Key exclusion criteria (16 listed)
- Have received prior PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmphinexPhotosensitiser | Drug | Amphinex based PCI of bleomycin |
| BleomycinAnticancer agent | Drug | Amphinex based PCI of bleomycin |
| LaserAlso: Ceralas PDT 652+/-3nm 2W" by CeramOptec GmbH CE0297Laser that emits red light at 652 nm. | Device | Amphinex based PCI of bleomycin |
Primary outcome
To assess the combined tolerability and efficacy of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin
Time frame: From Baseline to 3 months
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.
1 secondary outcome
To evaluate the safety of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin.
Time frame: From Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Forster, MD principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amphinex, Bleomycin and Laser in people with Cutaneous or Sub-cutaneous Malignancies, run by PCI Biotech AS at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the combined tolerability and efficacy of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin (time frame: From Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2014.