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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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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    Summary
    EudraCT Number:2014-001377-14
    Sponsor's Protocol Code Number:PimTo-MF-2014
    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:2014-05-08
    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 number2014-001377-14
    A.3Full title of the trial
    A multicenter, single arm, phase II clinical trial of pimecrolimus administered topically to patients with Stages Ia-IIa mycosis fungoides.
    Ensayo clínico de fase II, multicéntrico y con un único grupo de Pimecrolimus Tópico en Micosis Fungoide estadio Ia-IIa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with pimecrolimus cream of early Stage Mycosis Fungoides.
    Tratamiento con pimecrolimus crema de la micosis fungoides en estadio precoz.
    A.3.2Name or abbreviated title of the trial where available
    Study PimTo-MF.
    Estudio PimTo-MF
    A.4.1Sponsor's protocol code numberPimTo-MF-2014
    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 SponsorFundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre
    B.1.3.4CountrySpain
    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 supportISCIII
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportIIS del Hospital Universitario 12 de Octubre
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressCentro de Actividades Ambulatorias, Bloque D, 6ª planta, Av Córdoba s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28041
    B.5.3.4CountrySpain
    B.5.4Telephone number34917792635
    B.5.6E-mailensayosclinicos.uic@h12o.es
    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 Elidel 10 mg/g crema
    D.2.1.1.2Name of the Marketing Authorisation holderMEDA Pharma S.A.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePimecrolimus
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    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 INNPimecrolimus
    D.3.9.1CAS number 137071-32-0
    D.3.9.3Other descriptive namePimecrolimus
    D.3.9.4EV Substance CodeSUB16457MIG
    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) 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
    Patients with Stages Ia-IIa of Mycosis Fungoides.
    Pacientes con micosis fungoide estadio Ia-IIa.
    E.1.1.1Medical condition in easily understood language
    Patients with early Stages of Mycosis Fungoides.
    Pacientes con micosis fungoide en fases tempranas Ia-IIa.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Efficacy of pimecrolimus administered topically as measured by response rate (partial + complete responses) determinated by investigator assessment.
    Evaluar la eficacia de pimecrolimus tópico en términos de tasa de respuesta (respuestas parciales + completas) evaluada por el investigador.
    E.2.2Secondary objectives of the trial
    Time to response
    Duration of response
    Disease-free survival
    Progression-free survival
    Safety (Adverse events)
    Other tumors
    Objectives of translational research (exploratory), optional
    Tiempo hasta respuesta
    Duración de la respuesta
    Supervivencia libre de enfermedad
    Supervivencia libre de progresión
    Seguridad (AA)
    Segundos tumores
    Objetivos de investigación traslacional (exploratorios), opcionales
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Potential predictors of efficacy (in tumour tissue): identification of biomarkers that can be used to reliably predict or assess whether this therapy would provide benefit to patients. To explore biomarkers in patients with an early Stages of mycosis fungoides that might be used to better understand the mechanism of action of pimecrolimus administered topically and to predict efficacy and adverse events caused by the IMP.
    Predictores potenciales de eficacia (en el tejido tumoral): identificación de biomarcadores que puedan usarse para predecir o determinar si este terapia podría proporcionar un beneficio real a los pacientes. Investigar los biomarcadores en pacientes con estadios tempranos de Micosis Fungoide que podrían ser utilizados para comprender mejor el mecanismo de acción de pimecrolimus administrado por vía tópica y para predecir la eficacia y los efectos adversos causados ??por el fármaco en investigación (IMP).
    E.3Principal inclusion criteria
    Histological diagnosis of Mycosis Fungoides (Stage IA-IIA) confirmed by previous or current biopsy. If the previous biopsy was inconclusive, a confirmatory biopsy must be obtained before entering the study.
    Willingness and ability to sign inform consent and sign it up.
    Functional status according to the Eastern Cooperative Oncology Group (ECOG) of the subject between 0 and 1 at the screening visit.
    Age ? 18 years.
    An acceptable organic functional condition defined by certain hematological and biochemical values.
    Women of childbearing potential must have a pregnancy test negative seven days before inclusion in the study.
    Patients women and men married to women of childbearing potential must use contraception during the entire period of treatment and for one month afterwards. A non-hormonal contraceptive treatment is also necessary for women who use hormonal measures. Men with female partners of childbearing age or pregnant women, patients must use condoms in sexual intercourse during the treatment period.
    Breastfeeding women should discontinue nursing prior to treatment initiation.
    Diagnóstico histológico de Micosis Fungoide (estadio clínico IA-IIA), confirmado por biopsia de lesión actual o previa. Si la biopsia previa no fue concluyente, debe obtenerse una biopsia confirmatoria antes de entrar en el estudio.
    Voluntad y capacidad para firmar el consentimiento informado y firmarlo
    Estado funcional según el Eastern Cooperative Oncology Group (ECOG) del sujeto entre 0 y 1 en la visita de selección.
    Edad de 18 años o más.
    Una función orgánica aceptable definida por determinados valores hematológicos y bioquímicos.
    Mujeres en edad fértil deben tener un test de embarazo negativo siete días antes de la inclusión en el estudio.
    Pacientes mujeres y varones casados con mujeres en edad fértil, deben utilizar medidas anticonceptivas durante todo el periodo del tratamiento y hasta un mes después de terminar. Un tratamiento no hormonal anticonceptivo también es necesario para las mujeres que usan medidas hormonales. Los pacientes varones con compañeras sexuales en edad fértil o embarazadas, deberán utilizar condones en el acto sexual durante todo el periodo de tratamiento.
    Las mujeres lactando deben abandonar la lactancia antes del inicio del tratamiento.
    E.4Principal exclusion criteria
    Subjects with a history of other primary malignancies within 5 years prior or concomitant (except in situ cancer, basal cell carcinoma or squamous cell skin carcinoma, adequately treated).
    Known or suspected hypersensitivity to treatment with tacrolimus or pimecrolimus.
    No previous wash up of at least 1 month of any previous treatment unless patient is in progressive disease. In that case wash up should be at least 2 weeks.
    Concurrent treatment for Mycosis Fungoides. Topical or systemic corticosteroids are strictly prohibited. It is not allowed concurrent use of other calcineurin inhibitors.
    Patient not fully recovered from toxicity/adverse event secondary to any previous treatment.
    Diagnosis of any serious intercurrent illness or infection at the time of entering the study, which may interfere with the study treatment.
    Patients who are unable to apply, either by themselves or by their relatives or carers, the study investigational drug in the affected areas.
    Known contraindication to pimecrolimus or its excipients.
    Patienst must not have participated in another clinical trial in the 30 days prior to entry into this trial nor have participated in any other study with tacrolimus or pimecrolimus.
    Diagnosis of active or chronic infection with HIV, HBV or HCV. Absence of any active infection.
    Psychological, familial, sociological or geographical condition that may impede compliance with the study protocol and follow-up program, these conditions should be discussed with the patient before inclusion in the trial.
    Sujeto con antecedentes de otros tumores malignos primarios en los 5 años previos o concomitantes (excepto cáncer in situ, carcinoma basocelular o carcinoma espinocelular cutáneo, adecuadamente tratados).
    Hipersensibilidad previa conocida o sospecha de la misma al tratamiento con tacrolimus o pimecrolimus.
    No someterse a un Periodo de lavado de 1 mes a cualquier tratamiento previo salvo que esté en progresión en cuyo caso el lavado deberá ser de al menos de 2 semanas.
    Estar recibiendo tratamientos concurrentes para la micosis fungoide. Los corticoides tópicos o sistémicos están estrictamente prohibidos. No está permitido el uso concurrente de otros inhibidores de calcineurina.
    Paciente no recuperado totalmente de toxicidad/acontecimiento adverso debida a cualquier otro tratamiento previo.
    Diagnóstico de cualquier enfermedad grave intercurrente o infección en el momento de entrar en el estudio, que puedan interferir con el tratamiento del estudio.
    Pacientes que no son capaces de aplicarse bien por ellos mismos o por sus familiares o cuidadores el fármaco en estudio en las zonas indicadas
    Contraindicaciones conocidas a pimecrolimus o a sus excipientes
    Los pacientes no pueden haber participado en otro ensayo clínico con fármacos en los 30 días anteriores a la entrada en este ensayo, ni debe haber participado en cualquier otro estudio con tacrolimus o pimecrolimus.
    Diagnóstico de infección activa o crónica por VIH, VHB o VHC. Ausencia de cualquier infección activa.
    Condiciones psicológicas, familiares, sociológicas o geográficas que puedan entorpecer el cumplimiento del protocolo del estudio y el programa de seguimiento; estas condiciones deberán ser discutidas con el paciente antes de incluirlo en el ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Response rate calculated as partial response + complete response per investigator assessment.
    Tasa de respuesta calculada como respuestas parciales + respuestas completas determinadas por evaluación del investigador.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 4 weeks during treatment period and every 8-12 weeks during the follow-up period.
    Cada 4 semanas durante el tratamiento y cada 8-12 semanas durante el periodo de seguimiento.
    E.5.2Secondary end point(s)
    Time to response
    Duration of response
    Disease-free survival
    Progression-free survival
    Safety (Adverse events)
    Other tumors
    Objectives of translational research (exploratory), optional.
    Response will be evaluated according to the following criteria:
    Complete response: 100% clearance of skin lesions.
    Partial response: 50%-99% clearance of skin disease from baseline withour new tumors.
    Stable disease: <25% increase to <50% clearance in skin disease from baseline without new tumors.
    Progressive disease: ?25% increase in skin disease from baseline or new tumors.
    Relapse: Any disease recurrence in those with complete response.
    Tiempo hasta respuesta
    Duración de la respuesta
    Supervivencia libre de enfermedad
    Supervivencia libre de progresión
    Seguridad (AA)
    Segundos tumores
    Objetivos de investigación traslacional (exploratorios), opcionales
    Las respuestas se evaluarán conforme a los criterios siguientes:
    Respuesta completa: mejoría del 100%.
    Respuesta parcial: lesiones entre el 50-99% respecto al basal sin nuevos tumores.
    Enfermedad estable: variación <25% de empeoramiento o <50% de mejoría respecto al estado basal.
    Progresión de la enfermedad: si la afectación cutánea con respecto al basal es ?25% o se manifiestan nuevos tumores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 4 weeks during treatment period and every 8-12 weeks during the follow-up period.
    Cada 4 semanas durante el tratamiento y cada 8-12 semanas durante el periodo de seguimiento.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 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 No
    E.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    Última visita del último paciente.
    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 months
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    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)
    Normal clinical practise for this disease.
    Práctica clínica habitual para este tipo de enfermedad.
    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 Decision2014-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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