Head and Neck CancerPhase 1/2NCT02070432
Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer
A Phase 1/2 study testing LUZ11 in people with Head and Neck Cancer, run by Luzitin SA at 2 sites in Portugal.
Trial summary
This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- LUZ11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesPortugal
- Study dates
- Feb 2014to Jul 2016
- Phase
- Phase 1/2
- 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
- Written informed consent
- Men or non-pregnant, non-breast feeding women
- Karnofsky performance status of 60% or greater
- Histologically confirmed recurrent/refractory squamous cell carcinoma of the head and neck
- Clearly visible tumor on the oral cavity or cutaneous surface
Who cannot join
- Known hypersensitivity to any of the formulation ingredients
- Known hypersensitivity to porphyrins
- Porphyria or other diseases exacerbated by light
- Tumors known to be eroding into a major blood vessel in or adjacent to the irradiation site
- Planned skin phototherapy session(s) within the study timeframe
- Planned surgical procedure within the study timeframe
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- Coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe
- Existing therapy with a photosensitizing agent
- Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to screening
- Myocardial infarction within 6 months prior to screening
- Contraindication to MRI with gadolinium
- Unacceptable laboratory abnormalities
- Clinically relevant 12-lead ECG abnormalities
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites, 2 recruiting
- Recruiting
Hospital CUF Porto
Porto, 4100-180
Lucio Lara-Santos, MD, PhD, llarasantos@gmail.com
Lucio Lara Santos, MD, PhD
- Recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto)
Porto, 4200-072
Lucio Lara-Santos, MD, PhD, +351225084000, llarasantos@gmail.com
About this study
Official title: An Open-label Study to Investigate the Tolerability, Pharmacokinetics and Anti-tumour Effect Following Photodynamic Therapy (PDT) With Single-ascending Doses of LUZ11 in Patients With Advanced Head and Neck Cancer
This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.
Read the detailed description
LUZ11 is a new photosensitizer for use in photodynamic therapy (PDT) of solid tumors, such as head and neck cancer. PDT with LUZ11 involves the intravenous administration of LUZ11 followed by irradiation of the target tumor with laser light of an appropriate wavelength. The light causes the drug to react with oxygen, which forms reactive oxygen species (ROS) locally and induces tumor cells death and damages the blood vessels of the tumor thus preventing it from receiving nutrients.
The primary objective of this study is to assess the tolerability of LUZ11 following single ascending doses of LUZ11. The secondary objectives of this study are to explore the LUZ11 dose that has anti-tumor effect following photoactivation and to determine LUZ11 pharmacokinetics.
- Conditions
- Head and Neck Cancer
- Being tested
- LUZ11
- Keywords
- LUZ11, head and neck cancer, photodynamic therapy, Redaporfin
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUZ11Drug
LUZ11 i.v. administration followed by laser light irradiation
| Study group | Role | What they receive |
|---|---|---|
| LUZ11 PDT | Experimental | Study consists of two phases, in each participant:
1. Dose-finding phase with sequential periods in which single-ascending doses of LUZ11 will be titrated up to a dose that shows to be effective following photoirradiation of small spots of tumor surface.
2. Final PDT session with the previously identified individual effective dose. Receives: Drug: LUZ11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session
Secondary outcomes (1)
Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy
Measured: Up to 21 days after each dose-finding PDT session, and up to 13 weeks after final PDT session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzitin SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Almeida, MD, PhD, Study director, Luzitin SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070432
- Sponsor's protocol ID
- LUZ11-CDU-001
- Other IDs
- 2013-003133-14
- Status last verified
- Mar 2016
- First submitted
- 20 Feb 2014
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Investigate the Tolerability, Pharmacokinetics and Anti-tumour Effect Following Photodynamic Therapy (PDT) With Single-ascending Doses of LUZ11 in Patients With Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02070432
- Acronym / sponsor ID
- LUZ11-CDU-001
- Conditions
- Head and Neck Cancer
- Keywords
- LUZ11, head and neck cancer, photodynamic therapy, Redaporfin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Luzitin SAIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 25 Feb 2014 (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.
This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.
Detailed description
LUZ11 is a new photosensitizer for use in photodynamic therapy (PDT) of solid tumors, such as head and neck cancer. PDT with LUZ11 involves the intravenous administration of LUZ11 followed by irradiation of the target tumor with laser light of an appropriate wavelength. The light causes the drug to react with oxygen, which forms reactive oxygen species (ROS) locally and induces tumor cells death and damages the blood vessels of the tumor thus preventing it from receiving nutrients.
The primary objective of this study is to assess the tolerability of LUZ11 following single ascending doses of LUZ11. The secondary objectives of this study are to explore the LUZ11 dose that has anti-tumor effect following photoactivation and to determine LUZ11 pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LUZ11 PDT | Experimental | Drug: LUZ11Study consists of two phases, in each participant: 1. Dose-finding phase with sequential periods in which single-ascending doses of LUZ11 will be titrated up to a dose that shows to be effective following photoirradiation of small spots of tumor surface. 2. Final PDT session with the previously identified individual effective dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Men or non-pregnant, non-breast feeding women
- Karnofsky performance status of 60% or greater
- Histologically confirmed recurrent/refractory squamous cell carcinoma of the head and neck
- Clearly visible tumor on the oral cavity or cutaneous surface
Key exclusion criteria (13 listed)
- Known hypersensitivity to any of the formulation ingredients
- Known hypersensitivity to porphyrins
- Porphyria or other diseases exacerbated by light
- Tumors known to be eroding into a major blood vessel in or adjacent to the irradiation site
- Planned skin phototherapy session(s) within the study timeframe
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 |
|---|---|---|
| LUZ11LUZ11 i.v. administration followed by laser light irradiation | Drug | LUZ11 PDT |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session
1 secondary outcome
Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy
Time frame: Up to 21 days after each dose-finding PDT session, and up to 13 weeks after final PDT session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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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.
Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto)
Porto, Portugal
Luis Almeida, MD, PhD study director
Luzitin SA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LUZ11 in people with Head and Neck Cancer, run by Luzitin SA at 2 sites in Portugal.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session). 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 3 Mar 2016.