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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7263   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2013-003133-14
    Sponsor's Protocol Code Number:LUZ11-CDU-001
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-09-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2013-003133-14
    A.3Full title of the trial
    An open-label study to investigate the tolerability, pharmacokinetics and anti-tumor effect following photodynamic therapy (PDT) with single-ascending doses of LUZ11 in patients with advanced head and neck cancer.
    Ensaio clínico aberto para investigação da tolerabilidade, farmacocinética e efeito antitumoral após terapia fotodinâmica com doses únicas ascendentes de LUZ11, em doentes com cancro avançado de cabeça e pescoço.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label study to investigate the tolerability, pharmacokinetics and anti-tumor effect following photodynamic therapy (PDT) with single-ascending doses of LUZ11 in patients with advanced head and neck cancer.
    Ensaio clínico aberto para investigação da tolerabilidade, farmacocinética e efeito antitumoral após terapia fotodinâmica com doses únicas ascendentes de LUZ11, em doentes com cancro avançado de cabeça e pescoço.
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberLUZ11-CDU-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLuzitin, S.A.
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLuzitin, S.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBlueclinical - Investigacao e Desenvolvimento em Saude, Lda
    B.5.2Functional name of contact pointBlueclinical, Ltd.
    B.5.3 Address:
    B.5.3.1Street AddressAv. Villagarcia de Arosa, 1919 - 1º
    B.5.3.2Town/ cityMatosinhos
    B.5.3.3Post code4460-439
    B.5.4Telephone number00351220995159
    B.5.5Fax number00351223200699
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRedaporfin
    D.3.2Product code LUZ11
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRedaporfin
    D.3.9.3Other descriptive nameLUZ11
    D.3.9.4EV Substance CodeSUB166503
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50/6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced head and neck cancer.
    E.1.1.1Medical condition in easily understood language
    Advanced head and neck cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the tolerability of Redaporfin following single ascending doses of Redaporfin activated with a dose of 50 J/cm2 of laser light at 749±3 nm.
    E.2.2Secondary objectives of the trial
    To explore the Redaporfin dose that has anti-tumour effect following activation with a dose of 50 J/cm2 of laser light at 749±3 nm.
    To measure the plasma concentrations of Redaporfin and its metabolites and to determine the corresponding pharmacokinetic parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to give written informed consent and adhere to all requirements of the study.
    2. Man or non-pregnant and non-breast feeding woman.
    3. Age ≥ 18 years.
    4. Karnofsky performance status of 60% (60% = requiring some help, can take care of most personal requirements) or greater.
    5. With histologically confirmed diagnosis of recurrent/refractory squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified (NOS), etc.) of the head/neck.
    6. Clearly visible tumour on the oral cavity or cutaneous surface and that is locally accessible for surface irradiation using a microlens optic fibre.
    7. Head and neck squamous cell carcinoma (HNSCC) progressing after first line of palliative chemotherapy OR progressing ≤ 6 months after radical chemoradiotherapy OR considered not suitable for standard anti-neoplastic treatment by a multidisciplinary team.
    8. Absolute granulocyte count >1,500 cells/mL.
    9. Platelet count >100,000 cells/mL.
    10. Haemoglobin >9.0 g/dL (the use of transfusion or other intervention to achieve Hgb >9.0 g/dL is acceptable).
    11. Total bilirubin < 2 times the upper limit of normal (ULN).
    12. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
    13. Serum creatinine < 2 times the ULN or creatinine clearance (CrCL) >50 mL/min determined by 24-h urine collection or estimated by Cockroff-Gault formula: CrCL male = [(140-age) x (weight in kg] /[(serum Cr mg/dL) x (72)]; CrCL female = 0.85 x (CrCL male).
    14. If woman, she is not of childbearing potential or she agrees to use a medically effective means of birth control.
    15. If man, he is not sexually active or he agrees to use a medically effective means of birth control.
    E.4Principal exclusion criteria
    1. Life expectancy less than 6 months.
    2. Known hypersensitivity to porphyrins or any of the formulation ingredients.
    3. History of severe hypersensitivity reactions to any drugs.
    4. Porphyria or other diseases exacerbated by light.
    5. Metastatic or locoregional progressive disease not amenable for complete treatment by PDT.
    6. Tumours known to be eroding into a major blood vessel in or adjacent to the irradiation site.
    7. Planned skin phototherapy session within the study timeframe.
    8. Planned surgical procedure within the study timeframe.
    9. Coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe.
    10. Existing therapy with a photosensitising agent.
    11. Unacceptable laboratory abnormalities.
    12. Clinically relevant 12-lead ECG abnormalities.
    13. Unstable angina and/or congestive heart failure requiring hospitalisation within 6 months prior to screening.
    14. Myocardial infarction within 6 months prior to screening.
    15. Cannot communicate reliably with the investigator.
    16. Unlikely to co-operate with the requirements of the study.
    17. Contra-indication to MRI with gadolinium (e.g., use of pacemaker, allergy to gadolinium).
    18. Participation in a clinical trial within 2 months prior to screening.
    19. If woman, she has a positive pregnancy test.
    20. If woman, she is currently breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    Pharmacokinetics (PK): Cmax, AUC0-t, AUC0-∞, AUC0- t/AUC0-∞, Tmax, t½, λz, Vd and CL
    Depth of tumour necrosis, as assessed by diffusion-weighted and perfusion MRI with gadolinium.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK: before infusion start; at infusion completion; and at 0.08 (5 minutes), 0.5 (30 minutes), 0.75 (45 minutes), 1, 3, 6, 12, 24, 48 and 72 h post-infusion completion.
    Depth of tumour necrosis: at admission, day 7, day 21 of each PDT treatment period and at the end of follow-up phase.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    single-ascending doses
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will undergo standard medical care for their condition.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-07
    P. End of Trial
    P.End of Trial StatusOngoing
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