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    Summary
    EudraCT Number:2012-004111-32
    Sponsor's Protocol Code Number:OTRAPAC
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-11-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-004111-32
    A.3Full title of the trial
    Prospective, open-label, multicentre study on the incidence of Squamous Cell Carcinoma and Actinic Keratoses in solid organ transplant recipients treated with per protocol, cyclic field application of MAL-PDT versus lesion adapted cryotherapy
    Prospektive Multicenterstudie zur Behandlung und Prophylaxe von aktinischen Keratosen und Plattenepithelkarzinomen bei organtransplantierten Patienten mittels zyklischer Feldbehandlung durch MAL-PDT versus läsionsgerichteter Therapie mit Kryotherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to compare the occurrence (or incidence) of the most common fair skin cancer in solid organ transplant recipients (squamous cell carcinoma) and its preliminary stage (actinic keratoses) in two different groups: One group is treated with a fixed combination of a cream followed by exposure to red light and the other group receives liquid nitrogen (cryotherapy) as lesion-directed therapy.

    A.4.1Sponsor's protocol code numberOTRAPAC
    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 SponsorCharité Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportGalderma International SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité Universitätsmedizin Berlin
    B.5.2Functional name of contact pointSkin Cancer Centre Charité
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number+49030450618265
    B.5.5Fax number+49030450518935
    B.5.6E-mailclaas.ulrich@charite.de
    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 Yes
    D.2.1.1.1Trade name Metvix
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma Laboratorium GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMetvix
    D.3.2Product code MAL-PDT
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethyl(5-amino-4-oxopentanoat)-hydrochlorid
    D.3.9.1CAS number 33320-16-0
    D.3.9.2Current sponsor codeMAL-PDT
    D.3.9.3Other descriptive nameMETHYL AMINOLEVULINATE
    D.3.9.4EV Substance CodeSUB22645
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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.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
    Squamous Cell Carcinoma and Actinic Keratoses in solid organ transplant recipients
    E.1.1.1Medical condition in easily understood language
    The most common fair skin cancer in solid organ transplant recipients (squamous cell carcinoma) and its preliminary stage (actinic keratoses).
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare efficacy of cyclic field MAL(Metvix®)-PDT versus cryotherapy in prevention of in-situ squamous cell carcinomas (de novo in-situ SCC, de novo AK) and invasive SCC at month 24.
    E.2.2Secondary objectives of the trial
    At month 12: Compare efficacy of cyclic field MAL(Metvix®)-PDT versus cryotherapy in prevention de novo AK, in-situ SCC, invasive SCC.
    At month 12 and 24: Compare efficacy of cyclic field MAL(Metvix®)-PDT versus cryotherapy in prevention of recurrent AK, de novo AK, Basal Cell Carcinoma (BCC), de-novo SCC, and verrucae.
    Compare time to first invasive and in situ SCC in both groups.
    Compare AK lesions response rate at each visit.
    Compare local safety profile of cyclic field MAL(Metvix®)-PDT versus cryotherapy.
    Compare investigator and subject’s overall satisfaction between goups.
    Compare investigator’s assessment of target area cosmesis between groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients who are able to understand and provide written informed consent to participate in the clinical trial (signed informed consent) according to ICH-GCP
    • Male or nonpregnant, nonlactating female
    • ≥18yrs.
    • immunosuppressed kidney- (including simultaneous kidney/pancreas-), liver-, lung- and heart-transplanted patients
    • Multiple mild to moderate AK (> 5 AK) distributed over 3 target areas on the face and/or scalp (each 8x18cm2)
    • at least one previous invasive SCC within one of the target areas during the last 12 months before enrolment (Day 1)
    • Patient under stable/unchanged immunosuppressive regimen within the 6 preceding months. For patients under mTOR inhibitors, the previous SCC must have occurred while the patients were receiving a stable mTOR inhibitor therapy for at least 6 months.
    • Negative urine pregnancy test (the detection limit of human Choriongonadotropine (hCG) must be below 25U/ml)
    • Patients willing to comply with the study protocol
    E.4Principal exclusion criteria
    • Patient with active invasive SCC in the target areas
    • Active AK grade III (Ohlsen et al.) or evidence of Bowen’s Disease (BD) in at least one target area
    • Known or suspected allergy or hypersensitivity to any of the trial ingredients such as methyl aminolevulinate, glyceryl monostearate, cetostearyl alcohol, poloxyl 40 stearate, methyl parahydroxy benzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, glycerol, white soft paraffin, cholesterol, isopropyl myristate, arachis oil (peanut oil), almond oil, oleyl alcohol and purified water
    • Patients with a porphyria
    • Patients with a morphoeic basal cell carcinoma within 5cm of any target area
    • Dermatological disease or condition that might be exacerbated by MAL(Metvix®)-PDT or cryotherapy treatment or may impair trial assessments
    • Evidence of unstable or uncontrolled clinically significant medical condition
    • Known or supposed systemic malignant tumor
    • Systemic chemotherapy within the last 1 year prior to randomisation
    • Current or previous (≤ 6 months) intake of retinoids or any other systemic treatment for AK or interferon-treatment
    • active topical treatment (excluding surgery) against non-melanoma skin cancer (NMSC) in at least one target area within the last 12 weeks prior to enrolment (Day 1)
    • Planned major change in the immunosuppression
    • Patients participating in a clinical trial within the last 4 weeks prior to randomisation
    • Female patients with childbearing potential without adequate contraception (oral contraceptive or intrauterine device during the study period and one month thereafter)
    • Patients who are detained or held under guard by arrangement of the law or authorities
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative incidence of SCC at month 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 24
    E.5.2Secondary end point(s)
    Secondary Endpoints
    • Cumulative Incidence of new AK at month 12 and 24
    • Cumulative Incidence of SCC at month 12
    • Cumulative Incidence of BCC at month 12 and 24
    • Cumulative Incidence of Verrucae at month 12 and 24
    • % of change from baseline in total AK number at each visit.
    • Decrease of lesions count assessed at each visit from baseline
    • Number of cryotherapy sessions reactively needed in reference study arm
    • Median time to occurrence of new AK
    • Median time to occurrence of new SCC

    Safety Endpoints
    • Frequency and severity of adverse events at each visit
    • Local tolerability assessed by subjects: % per score 7 days after each treatment session
    • Pain-Score: % per score after each treatment session
    • Skin cosmesis: % per score at each visit

    Other Endpoints
    • investigator and patient overall satisfaction
    • Cosmetic outcome
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 12 and 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 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
    Cryotherapy
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    Treatment after study completion will be planned by the investigator considering remaining treatment options and patient’s preferences.
    Falls der Patient im Verlauf der klinischen Prüfung seine Einwilligung zurückzieht, hat das keinen Einfluss auf seine weitere Behandlung. In diesem Fall wird sein Arzt unter der Berücksichtigung verbleibender Behandlungsmöglichkeiten und der Wünsche des Patienten andere für ihn geeignete Behandlungsmethoden auswählen. Die Behandlung erfolgt entweder weiter im Prüfzentrum oder in einer zur Behandlung geeigneten Stelle je nach Wunsch des Patienten.
    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 Decision2012-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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