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    Summary
    EudraCT Number:2010-022439-12
    Sponsor's Protocol Code Number:ATH008-CLN02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-12-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-022439-12
    A.3Full title of the trial
    Estudio de fase II multicéntrico, controlado con placebo, para investigar la seguridad y eficacia de la crema ATH008 en pacientes con Síndrome de Eritrodisestesia Palmar Plantar (SEPP) secundario a capecitabina en monoterapia
    A.4.1Sponsor's protocol code numberATH008-CLN02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAdvancell Advanced In Vitro Cell Technologies, S.A
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameATH008 cream 1%
    D.3.2Product code ATH008 cream
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllopurinol
    D.3.9.1CAS number 315-30-0
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typehypoxanthine analogon
    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 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 nameATH008 cream 3%
    D.3.2Product code ATH008 cream
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllopurinol
    D.3.9.1CAS number 315-30-0
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typehypoxanthine analogon
    D.IMP: 3
    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 nameATH008 cream 8%
    D.3.2Product code ATH008 cream
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllopurinol
    D.3.9.1CAS number 315-30-0
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typehypoxanthine analogon
    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 placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Palmar-Plantar Erythrodysesthesia Syndrome (PPES)

    Síndrome de Eritrodisestesia Palmar Plantar (SEPP)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10054524
    E.1.2Term Palmar-plantar erythrodysesthesia syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Parte I - Evaluación de la seguridad
    - Demostrar la seguridad de la crema ATH008 en pacientes que presentan SEPP secundaria a la monoterapia de capecitabina.
    - Determinar los niveles plasmáticos del ingrediente activo (alopurinol) y su metabolito (oxipurinol) cuando se administra la crema ATH008 de forma tópica.
    - Seleccionar la dosis para la Parte II de este estudio.
    Parte II - Evaluación de la seguridad y la eficacia primaria
    -Demostrar la seguridad de la crema ATH008 en pacientes que presentan SEPP secundaria a la monoterapia de capecitabina.
    -Demostrar la eficacia de la crema ATH008 en la reducción del número de sujetos que presentan SEPP de grado 2/3 secundario a monoterapia de capecitabina.
    E.2.2Secondary objectives of the trial
    Part I
    - To determine the grade of PPES at Day 1 and Day 21 of ATH008 cream treatment.

    Parte I
    - Determinar el grado de SEPP el Día 1 y el Día 21 del tratamiento con la crema ATH008.

    Part II - Secondary Efficacy evaluation
    - To demonstrate the efficacy of ATH008 cream in improving the quality of life of patients presenting PPES.
    - To demonstrate the efficacy of ATH008 cream in improving the signs and symptoms of PPES.

    Parte II - Evaluación de la eficacia secundaria
    - Demostrar la eficacia de la crema ATH008 en la mejora de la calidad de vida de los pacientes que presentan SEPP.
    - Demostrar la eficacia de la crema ATH008 en la mejoría de los signos y síntomas del SEPP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Have signed Informed Consent.
    - Are under capecitabine monotherapy for treatment of colon or breast cancer at a regimen of 2 weeks on and 1 week off (14+7) and a daily doses between 2000 and 2500 mg/m2.
    - Diagnosis of PPES grade 1 in any hand or foot according to the NCI CTCAE v4.03 definition.
    - Are able to apply topical medication or provide for another person to apply it.
    - Have a life expectancy longer than 3 months.
    - In Part I, subjects still have to undergo at least 1 planned cycle with capecitabine monotherapy.
    - In Part II, subjects still have to undergo at least 2 planned cycles with capecitabine monotherapy

    - Haber firmado el consentimiento informado.
    - Estar en monoterapia de capecitabina para el tratamiento del cáncer de colon o de mama en un régimen de 2 semanas en tratamiento y 1 semana sin tratamiento (14+7) y a una dosis diaria de entre 2000 y 2500 mg/m2.
    - Diagnóstico de SEPP de grado 1 en cualquiera de las manos o pies de acuerdo con la definición del NCI CTCAE v4.03 (Apéndice 20.1).
    - Poder aplicarse medicación tópica o poder hacer que otra persona se la aplique.
    - Tener una esperanza de vida mayor a 3 meses.
    - En la Parte I, los sujetos aún tienen que someterse a al menos 1 ciclo planificado de monoterapia de capecitabina.
    - En la Parte II, los sujetos aún tienen que someterse a al menos 2 ciclos planificados de monoterapia de capecitabina.
    E.4Principal exclusion criteria
    - Are younger than 18 years.
    - Have neurologic symptoms greater than grade 1, which under the criteria of the clinician could interfere with PPES diagnosis or study treatment (e.g. hands or feet neuropathy).
    - Have any dermatologic condition that in the opinion of the investigator may affect hands or feet or may complicate evaluation during study treatment (e.g. neurodermatitis, psoriasis, etc).
    - Have developed onycholysis.
    -Need to use other emollient creams or other topical treatments in hands and/or feet during the study.
    - Are receiving radiotherapy.
    - Are actively treated with systemic allopurinol (oral or parenteral) for the treatment of gout, or any other indication.
    - Have developed a severe reaction to allopurinol in the past (e.g. Lyell syndrome).
    - Known allergy to allopurinol or any of the excipients of the product.
    - Previous contraindication to treatment with capecitabine.
    - Have received topical corticosteroids in hands and/ or feet 7 days prior to planned inclusion in the study.
    - Are participating in any other investigational studies for the treatment of PPES.
    - Have participated in any other investigational studies for the treatment of PPES, or received an experimental therapeutic procedure, considered to potentially interfere with the study in the 4 weeks preceding Day 1.
    - Have a serious medical or psychiatric condition that could, in the investigator?s opinion, potentially interfere with their study treatment or participation in the study.
    - Pregnant women, women in child bearing age not using contraceptives or men not using contraceptives.
    - Are participating in other clinical trials.

    - Ser menor de 18 años.
    - Tener síntomas neurológicos de más de grado 1, que según el criterio del facultativo podrían interferir con el diagnóstico del SEPP o con el tratamiento en estudio (p. ej., neuropatía en pies o manos).
    - Tener cualquier afección dermatológica que, según la opinión del investigador, pueda afectar a los pies o las manos o pueda dificultar la evaluación durante el tratamiento del estudio (p. ej., neurodermatitis, psoriasis, etc.).
    - Haber desarrollado onicólisis.
    - Necesidad de usar otras cremas emolientes u otros tratamientos tópicos en manos y/o pies durante el estudio.
    - Estar recibiendo radioterapia.
    - Estar bajo tratamiento simultáneo con alopurinol sistémico (oral o parenteral) para el tratamiento de la gota, o para cualquier otra indicación.
    - Haber desarrollado anteriormente una reacción grave al alopurinol con (p. ej., el síndrome de Lyell).
    - Alergia conocida al alopurinol o a cualquiera de los excipientes del producto.
    - Contraindicación previa al tratamiento con capecitabina.
    - Haber recibido corticosteroides tópicos en manos o pies 7 días antes de la inclusión prevista en el estudio.
    - Estar participando en cualquier otro estudio de investigación para el tratamiento del SEPP.
    - Haber participado en otros estudios de investigación para el tratamiento del SEPP, o haber recibido un procedimiento terapéutico experimental, que se considere que puede interferir potencialmente en el estudio, en las 4 semanas que preceden al Día 1.
    - Tener una afección médica o psiquiátrica que pudiera, en opinión del investigador, interferir potencialmente con su tratamiento del estudio o con su participación en el estudio.
    - Mujeres embarazadas, mujeres en edad fértil que no usen anticonceptivos u hombres que no usen anticonceptivos.
    - Estar participando en otros ensayos clínicos.
    E.5 End points
    E.5.1Primary end point(s)
    Safety variables
    Part I and II
    Adverse events and serious adverse events (incidence, causality, and severity) related to treatment with ATH008 cream.
    Variables de seguridad
    Partes I y II
    Acontecimientos adversos y acontecimientos adversos graves (incidencia, causalidad y gravedad) relacionados con el tratamiento con la crema ATH008.

    Pharmacokinetic variables
    Part I
    - Plasmatic allopurinol levels.
    - Plasmatic oxypurinol levels.
    Part II
    None.
    Variables farmacocinéticas
    Parte I
    - Niveles plasmáticos de alopurinol.
    - Niveles plasmáticos de oxipurinol.
    Parte II
    Ninguna.

    Primary efficacy variable
    Part I
    None.

    Part II
    Percentage of subjects that develop PPES grade 2 or 3 according to the NCI CTCAE v4.03 criteria
    Variable de eficacia primaria
    Parte I
    Ninguna.
    Parte II
    Porcentaje de sujetos que desarrollan SEPP de grado 2 ó 3 según los criterios NCI CTCAE v4.03
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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 Information not present in EudraCT
    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
    This is provided in the protocol
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 90
    F.4.2.2In the whole clinical trial 90
    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)
    Subject will be allowed to continue with the ATH008 cream treatment and will be followed up separately until the end of capecitabine therapy or evolution of PPES to grade 2 or 3
    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 Decision2011-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-10
    P. End of Trial
    P.End of Trial StatusOngoing
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