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    Summary
    EudraCT Number:2013-000893-32
    Sponsor's Protocol Code Number:008171BLT
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-000893-32
    A.3Full title of the trial
    Squamous cell carcinoma prevention in organ transplant recipients using topical treatments: a feasibility study (SPOT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Skin cancer prevention in people who have had organ transplants by the use of treatment creams to get rid of actinic keratosis skin lesions (cancer precursors)- does this work?
    A.3.2Name or abbreviated title of the trial where available
    SPOT Trial v 1.0 (13th June 2013)
    A.4.1Sponsor's protocol code number008171BLT
    A.5.4Other Identifiers
    Name:CRCTU NumberNumber:SK2007
    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 SponsorQueen Mary University of London
    B.1.3.4CountryUnited Kingdom
    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 supportNational Institute of Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCancer Research UK Clinical Trials Unit (CRCTU)
    B.5.2Functional name of contact pointDr Joshua Savage
    B.5.3 Address:
    B.5.3.1Street AddressSchool of Cancer Sciences
    B.5.3.2Town/ cityBirmingham
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0121 4149247
    B.5.5Fax number0121 4148392
    B.5.6E-mailSPOT@trials.bham.ac.uk
    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 Aldara
    D.2.1.1.2Name of the Marketing Authorisation holderMeda AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameImiquimod
    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 INNimiquimod
    D.3.9.1CAS number 99011-02-6
    D.3.9.3Other descriptive nameAldara
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 Efudix cream
    D.2.1.1.2Name of the Marketing Authorisation holderMeda Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 name5-Fluorouracil
    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 INNFluorouracil
    D.3.9.1CAS number 51-21-8
    D.3.9.3Other descriptive name5-FU / Efudix
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Actinic keratosis (and cutaneous squamous cell carcinoma)
    E.1.1.1Medical condition in easily understood language
    Red, scaly skin lesions that may develop into cancerous skin lesions
    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
    Cutaneous squamous cell carcinoma (cSCC) is economically a major burden to the NHS. The incidence is rising rapidly, with approximately 30,000 new cases per year in the UK. Immunosuppressed organ transplant recipients (OTR) have a more than 100-fold increased risk and an accelerated carcinogenic process, making them an ideal population in which to test interventions aimed at preventing cSCC. Premalignant lesions, termed actinic keratoses (AK), are present on sun-damaged skin and effective topical agents are available to treat them. The close relationship between AK and cSCC means that such topical treatment of a field bearing multiple AK should significantly reduce subsequent risk of developing cSCC, but this assumption has never been proven. The main objective of the study is thus to determine the feasibility of performing a larger phase III randomised controlled trial using topical treatment of AK as a strategy for prevention of invasive cSCC.
    The decision to perform a phase III ra
    E.2.2Secondary objectives of the trial
    1. To assess the activity of the treatment cream, determined by the clearance of AK at the end of the treatment period, the persistence of that clearance at the end of month 12, and the development of cSCC at 12 months after treatment.
    2. To develop and evaluate an objective clinical system for measuring AK, taking into account lesion size, erythema (redness), hyperkeratosis (dry and scaly texture) and whether the AK appear as a continuous field. In addition, AK diagnosis by clinicians using the system described above will be compared to an independent photographic assessment of AK to determine the level of agreement between the two methods and the utility of photographs as a means of measuring AK.
    3. Patient centred secondary objectives include ascertaining patient treatment preference and testing the sensitivity of QoL instruments in advance of a larger trial.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The Decision Choice Experiment (DCE) and Quality of Life (QoL) Study is integral part of the SPOT trial protocol. This study was developed at University of Dundee by Prof Charlotte Proby and Dr Paul Allanson. It is designed to establish patient treatment preferences and to pilot QoL measures for the phase III trial. These are key secondary objectives of the trial. The DCE includes 10 demographic questions, about lifestyle factors that may affect skin health, such as occupation, and the history of any skin problems including AK, treatments received for AK, and general health related variables. Patients are then given a range of hypothetical scenarios with photos of varying AK skin disease. They will be asked to choose from different hypothetical treatment options that vary in frequency and length of application, local skin response, improvement in skin appearance and reduction in skin cancer risk. This data will be used to determine which treatment option patients prefer. The QoL measure comprises parts of two published and validated questionnaires (used with permission) and one exploratory measure.
    The Long Questionnaire (Long Q) will comprise the DCE and QoL measures. Both organ transplant recipients and immunocompetent patients will complete the full version of this questionnaire at baseline (after being registered into the trial). A slightly abridged version of the Long Q will be completed by the organ transplant recipients on completion of treatment. Throughout the trial, the organ transplant recipients randomised into the trial will also be asked to complete the QoL questions only (formed into the Short Questionnaire, or Short Q) to gauge their health perceptions whilst on the medication.
    The baseline questionnaire will be given to patients when they attend the dermatology clinic. All other questionnaires will be sent in the post by the SPOT Trial Office. The questionnaire will be accompanied by a standard cover letter providing written instructions on how to complete the questionnaire. Patients will be instructed to return the questionnaires directly to the SPOT Trial Office in pre-paid envelopes provided.
    The SPOT Trials Office will securely forward the Long Q information to the Dundee Health Economics Group for analyses while the QoL questionnaire will be analysed by the CRCTU, University of Birmingham.
    The DCE has been piloted by the Dundee Group under a separate ethical approval.
    All versions of the questionnaire and the cover letter are included with the research ethics application. (Please note that the DCE questions are shuffled at random to avoid bias so are not sequentially numbered.)



    E.3Principal inclusion criteria
    1. Organ Transplant Recipient (OTR) Patient Group:
    •OTRs aged >18 years
    •A minimum of 10 AK (with at least 5 AK occurring within the same skin zone)
    •Demonstrably stable renal function on the basis of serum creatinine and estimated Glomerular Filtration Rate (eGFR)
    •No recent change in immunosuppressive medication and predicted to remain stable over course of the study
    •Able to apply topical cream as directed to the required area or having a carer who agrees to do this at the required frequency and times
    •Women of child-bearing potential, or men in a relationship with a woman of child-bearing potential, prepared to adopt adequate contraceptive measures if sexually active
    •Able to give written informed consent
    •Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
    2. Immunocompetent Patient Group (participating in the DCE substudy only):
    •ICP patients aged >18 years
    •Present or previous AK (any site, any number)
    •Able to give written informed consent
    •Willing to spend up at least 20 minutes completing the Long Q
    E.4Principal exclusion criteria
    Organ Transplant Recipients (OTR) only:
    •Pregnant (female patients of child bearing potential should have a urine or blood Human Chorionic Gonadotropin (hCG) test performed to rule out pregnancy prior to trial entry)
    •Lactating females. Patients who agree to discontinue nursing 14 days prior to commencing treatment and do not nurse throughout all the treatment period are eligible
    •Life expectancy less than 12 months
    •Known hypersensitivity to 5-fluorouracil, imiquimod, sunscreen, or to any of the excipients (including but not limited to: methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol, stearyl alcohol, polysorbate 60, propylene glycol, methyl parahydroxybenzoate and white soft paraffin)
    •The use of brivudine, sorivudine and analogues is prohibited

    E.5 End points
    E.5.1Primary end point(s)
    The main objective of this phase II trial is to determine the feasibility of performing a phase III randomised controlled trial using topical treatment of AK as a strategy for prevention of invasive cSCC.
    The decision to perform a phase III randomised controlled trial will be based on a number of factors including:
    •the proportion of eligible patients willing to be randomised;
    •the proportion of patients who complete Treatment Cycle 1, for each active treatment arm;
    •the proportion of patients who require Treatment Cycle 2 completed for each active treatment arm;
    •the proportion of patients who would be willing to use the treatment again,
    in addition to the activity of the interventions.


    E.5.1.1Timepoint(s) of evaluation of this end point
    The first main analysis will be performed once all patients have been followed up for a minimum of 16 weeks post-treatment, i.e, once the last patient to enter has completed month 7. Final analysis will be carried out after all patients have been followed up for a minimum of 12 months.
    E.5.2Secondary end point(s)
    1. The activity outcome measures will be determined by the following criteria:
    •Clearance of AK trial treatment field(s): defined as the proportion of AKs identified at baseline that are no longer detectable at 4 and 8 weeks post treatment
    •Persistence of AK clearance trial treatment field(s): defined as the proportion of AKs which were cleared at 4 and 8 weeks post treatment which remain undetectable at the completion of the 12 month follow-up period
    •Development of cSCC: defined as the time from entry into the trial until development of cSCC. Patients will be censored at the date last seen alive without development of cSCC.
    2. The evaluation outcome measures will be determined by the following criteria:
    •Evaluation of the proposed overall AK quantification scoring criteria: defined as scores designated for lesion size (including area of contiguous field change), erythema and hyperkeratosis
    •Measure concordance of AK diagnosis by clinicians: defined as assessing the concordance of clinicians scores vs the scores from the paired photographic assessments.
    3. The patient-centred outcome measures will be determined by:
    •Patient treatment preferences: defined as the preference weights or relative values put on the various treatment attributes (duration of treatment, frequency of application, severity of reaction; improvement in appearance, reduction in skin cancer risk)
    •Assessment of QoL measure: defined as differences between patient QoL scores before, during and after treatment and between alternative treatments.

    E.5.2.1Timepoint(s) of evaluation of this end point
    As above, for evaluation of primary endpoint.
    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 Yes
    E.6.4Safety Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Standard care, i.e., discretionary use of sunscreen alone; also used discretionarily in other arms
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    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
    The end of trial will be 6 months after the last patient last visit. This will allow sufficient time for the completion of protocol procedures, data collection and data input. The SPOT Trial Office will notify the Sponsor, the MHRA and REC that the trial has ended and will provide them with a summary of the clinical trial report within 12 months of the end of trial.
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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.3.3.7.1Details of other specific vulnerable populations
    Elderly people with actinic keratoses that may become cancerous or have previously.
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    After the end of the study, participants will be treated by their clinician in the manner that he or she feels most appropriate.
    The treatment creams used in the study are licensed in the UK for the treatment of AK, so it is possible that they could be used again after the study in accordance with the manufacturers' directions.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-03
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