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    Summary
    EudraCT Number:2011-004797-28
    Sponsor's Protocol Code Number:NTNU2011-1
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-29
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2011-004797-28
    A.3Full title of the trial
    A randomized, controlled-blinded, multi-centre study of photodynamic therapy with methyl-aminolevulinate comparing a simplified regime with the approved regime in patients with clinical low-risk superficial and nodular basal cell carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparision of a simplified photodynamic therapy (PDT) regime with the approved PDT regime in the treatment of low-risk basal cell carcinoma
    A.4.1Sponsor's protocol code numberNTNU2011-1
    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 SponsorNorwegian University of Science and Technology (NTNU)
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNorwegian University of Science and Technology (NTNU)
    B.5.2Functional name of contact pointCato Mørk
    B.5.3 Address:
    B.5.3.1Street AddressTennisveien 19
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0777
    B.5.3.4CountryNorway
    B.5.4Telephone number004790082819
    B.5.5Fax number004767980011
    B.5.6E-mailcato.moerk@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Metvix
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMetvix
    D.3.2Product code 085195
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpicutaneous use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    Low-risk superficial and nodular basal cell carcinoma
    E.1.1.1Medical condition in easily understood language
    The most common and easily treated types of basal cell carcinomas
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to investigate if a more simple and flexible PDT treatment schedule (one single treatment session with re-treatment of non-complete responders-regime 1) for low-risk primary superficial or nodular BCC will be as effective as the standard and approved two-treatments one week apart.
    E.2.2Secondary objectives of the trial
    To investigate relationship between clinical and pathological tumour characteristics and the relationship between tumour recurrence rates with tumour thickness and histopathological subtypes and various immunhistochemical markers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria

    Patients
    • Males or females above 18 years of age.
    • Written informed consent.

    Lesions
    • One or more primary histologically verified BCC, clinically assessed as of either superficial or nodular type.
    E.4Principal exclusion criteria
    Exclusion Criteria
    Patients
    • Woman with child-bearing potential
    • Patients with Gorlin’s syndrome, porphyria, xeroderma pigmentosum, history of arsenic exposure or known allergy to MAL
    • Concomitant treatment with immunosuppressive medication
    • Patients with physical or mental conditions that most likely will prevent them from attending the follow-up visits

    Lesions
    • Located within the mid-face-H-area
    • Longest diameter >15 mm on face and scalp, >30 mm on the trunk and >20 mm on the limbs
    • Any clinically evaluated pigmented or morpheaform lesions
    • Any lesions with prior treatment
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be lesions cure rate and cosmetic outcome by treatment regime 1 compared to lesions cure rate by treatment regime 2, assessed 36 months after PDT.
    The number of lesion in need of a re-treatment 3 months following the first treatment session in regime 1 will be reported. Clinical suspected recurrences are confirmed by histology. Lesion response rate is defined as number of lesions in complete response at 12 and 36 months of follow-up. We will report on adverse advents occurring in relation to both treatment regimes from start of treatment to 3 months following last treatment. We will report on lesion recurrences among lesions treated with either regime 12 and 36 months after PDT. Cosmetic outcome will be determined by clinical assessment (visual inspection and palpation) 12 and 36 months after treatment. The results will be recorded on a 4-point ordinal scale as either excellent (absence of any stigmata other than scar formation after diagnostic punch biopsy), good (slight presence of fibrosis, atrophy or change of pigmentation), fair (moderate presence of fibrosis, atrophy or change in pigmentation) or poor (marked presence of fibrosis, atrophy or change in pigmentation).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 and 36 month after intervention
    E.5.2Secondary end point(s)
    The secondary endpoint will be to investigate relationship between clinical and pathological tumour characteristics and tumour recurrences rates, tumour thickness, histopathological BCC subtypes and immunohistochemical markers. Recurrence rate defined both as”raw” (total number of recurrences divided by the total number of tumours treated) and”strict recurrence rate” (total number of patients with recurrence divided by number of lesions observed for at least 36 month) will be reported.
    Recurrence rate in relation to BCC subgroup analyses including clinical (superficial or nodular tumour), tumour size and histological characteristics will also be reported. BCC will on the basis of histological growth pattern be divided into two main types (aggressive or non-aggressive type). Tumours will additionally be studied with various immunohistochemical markers for expression of cell proliferation, invasiveness, vascularisation and growth factors.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 36 month after intervention
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    one single PDT treatment session with re-treatment of non-complete responders after 3-month
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 277
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 277
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state374
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 374
    F.4.2.2In the whole clinical trial 374
    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)
    non-complete responders will be offered other established/normal treatments for their basal cell carcinomas
    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 Decision2012-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-09
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