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    Summary
    EudraCT Number:2020-000253-27
    Sponsor's Protocol Code Number:Pelle-926-301E
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-10
    Trial results View 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 number2020-000253-27
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects with Gorlin Syndrome (Basal Cell Nevus Syndrome)
    Estudio de fase III, Multicéntrico, abierto y de ampliación con patidegib gel tópico al 2% en pacientes con síndrome de Gorlin (síndrome basocelular nevoide)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Multicenter, unblinded Extension Study of Patidegib Topical Gel, 2% in patient with Gorlin Syndrome
    Estudio de fase III, multicéntrico, abierto y de ampliación con patidegib gel tópico al 2% en pacientes con síndrome de Gorlin
    A.3.2Name or abbreviated title of the trial where available
    PATIDEGIB Phase 3 OLE study in subjects with Gorlin syndrome
    Estudio de fase III, abierto y de ampliación con patidegib en pacientes con síndrome de Gorlin
    A.4.1Sponsor's protocol code numberPelle-926-301E
    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 SponsorPellePharm, Inc.
    B.1.3.4CountryUnited States
    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 supportPellePharm, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPellePharm, Inc.
    B.5.2Functional name of contact pointVP, Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address101 Mission Street, Suite 1950
    B.5.3.2Town/ citySan Francisco
    B.5.3.3Post codeCA 94105
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1(650) 580-9025
    B.5.6E-mailspendyala@pellepharm.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/1998
    D.3 Description of the IMP
    D.3.1Product namePatidegib Topical Gel 2%
    D.3.4Pharmaceutical form Gel
    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 INNPatidegib
    D.3.9.2Current sponsor codePatidegib
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Basal cell carcinomas (BCCs) in patients with Gorlin syndrome
    Carcinomas basocelulares (CBC) en pacientes con síndrome de Gorlin
    E.1.1.1Medical condition in easily understood language
    Skin cancer in patients with Gorlin syndrome
    Cáncer de piel en pacientes con síndrome de Gorlin
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10004151
    E.1.2Term Basal cell nevus syndrome
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess the safety and tolerability of Patidegib Topical Gel, 2% in patients who have completed PellePharm Study Pelle-926-201 or Pelle-926-301
    El objetivo principal del estudio es evaluar la seguridad y la tolerabilidad de patidegib gel tópico al 2%, en pacientes que completaron los estudios de PellePharm Pelle-926-201 o Pelle-926-301
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess the efficacy of Patidegib Topical Gel, 2% in patients who complete PellePharm Study Pelle-926-201 or Pelle-926-301
    El objetivo secundario del estudio es evaluar la eficacia de patidegib gel tópico al 2%, en pacientes que completaron los estudios de PellePharm Pelle-926-201 o Pelle-926-301
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject must be at least 18 years old.
    2. The subject must provide written informed consent prior to any study procedures.
    3. The subject must have completed PellePharm Study 926-201 or 926-301 with adequate compliance
    4. Study 926-301 subjects must have completed the End of Treatment Visit in Study 301, prior to the Screening Visit in this study. They must also complete all Study 301 related procedures prior to the Baseline Visit of this study.
    5. The subject must meet diagnostic criteria for Gorlin (basal cell nevus) syndrome, including major criterion #a plus 1 additional major criterion or plus 2 additional minor criteria listed in Appendix 17.2
    6. The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator. Moisturizers and emollients are allowed. Subjects will be encouraged to use their preferred sunscreen with a sunscreen protection factor (SPF) of at least 30 daily on all exposed skin sites.
    7. Female subjects must have a negative pregnancy test (serum pregnancy test at Screening Visit, urine pregnancy test at Baseline Visit). For Study 301 subjects, a negative serum pregnancy test result from Study 301 is acceptable if the test was done within 7 days of the Screening Visit of this study.
    8. If the subject is a woman of child bearing potential (WOCBP), she must be willing to use birth control methods which may be considered highly effective (Appendix 17.1). Hormonal contraception must be supplemented with a barrier method (preferably condom). Birth control must start prior to Baseline, continue through the duration of the study, and for 30 days after last application of IP
    9. If the subject is a male with a female sex partner who is a WOCBP, the subject must be willing to use condoms, even after a vasectomy, starting prior to Baseline, through the duration of the study, and for at least 3 months after the last application of IP.
    10. The subject is willing for all facial BCCs to be evaluated and follow treatment recommendations made only by the Investigator
    11. The subject is willing to forego treatment of facial BCCs with anything other than the study IP except when the Investigator believes that delay of treatment of a BCC potentially might compromise the health of the subject. In such instances, the only other allowed form of treatment is surgical.
    1. El sujeto debe tener al menos 18 años de edad.
    2. El sujeto debe proporcionar su consentimiento informado por escrito antes de cualquier procedimiento de estudio.
    3. El sujeto debe haber completado el estudio de PellePharm Pelle-926-201 o Pelle-926-301.
    4. Los sujetos del estudio Pelle-926-301 deben haber completado la visita de final de tratamiento del estudio 301 antes de la visita de selección de este estudio. A su vez, deben completar todos los procedimientos relacionados con el estudio 301 antes de la visita inicial de este estudio.
    5. El sujeto debe cumplir con los criterios de diagnóstico para el síndrome de Gorlin (síndrome basocelular nevoide), incluido el criterio principal #a más 1 criterio mayor adicional o más 2 criterios menores adicionales enumerados en el Apéndice 17.2
    6. El sujeto debe estar dispuesto a abstenerse de aplicarse un medicamento de uso tópico (con o sin receta) que no pertenezca al estudio en la piel de la cara durante el transcurso del ensayo, excepto en caso de prescripcion del investigador. Se permite el uso de hidratantes y emolientes. Se alentará a los sujetos a usar su crema solar de preferencia, con un factor de protección solar (FPS) de al menos 30, todos los días en las zonas cutáneas expuestas.
    7. Las sujetos deben presentar un resultado negativo en la prueba de embarazo (prueba de embarazo en suero en la visita de selección, prueba de embarazo en orina en la visita inicial). Para las sujetos procedentes del estudio 301, resulta aceptable la obtención de un resultado negativo en la prueba de embarazo en suero del estudio 301 si la prueba se realizó en los 7 días previos a la visita de selección de este estudio.
    8. Si el sujeto es una mujer en edad fértil, debe mostrarse dispuesta a emplear métodos anticonceptivos que se consideren de alta eficacia (Apéndice 17.1). La anticoncepción hormonal debe complementarse con un método de barrera (preferiblemente preservativo). La anticoncepción debe comenzar antes del inicio y prolongarse durante toda la duración del estudio y hasta 30 días después de la última administración del PEI.
    9. Si el sujeto es varón con pareja de sexo femenino en edad fértil, el sujeto debe mostrarse dispuesto a usar un preservativo, incluso después de haberse sometido a una vasectomía, desde antes del inicio, durante toda la duración del estudio y hasta al menos 3 meses después de la última administración del PEI.
    10. El sujeto está dispuesto a someterse a al evaluación de todos los carcinomas basocelulares (CBC) faciales y a seguir las recomendaciones terapéuticas propuestas únicamente por el investigador.
    11. El sujeto se muestra dispuesto a renunciar al tratamiento de los CBC con cualquier otro tratamiento distinto del PEI del estudio, salvo cuando el investigador crea que retrasar el tratamiento de un CBC pueda poner en riesgo la salud del sujeto. En dichos casos, la única forma de tratamiento permitida será la quirúrgica.
    E.4Principal exclusion criteria
    1. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP. Among these are use of the following:
    a. 5-fluorouracil, imiquimod, or Ingenol mebutate (except as topical treatment to anatomical areas other than the face) systemically or topically to the skin within the 2 months prior to the Screening and Baseline Visit.
    b. Systemic chemotherapy within 1 year prior to the Screening and Baseline Visit.
    c. Known inhibitors of the Hedgehog signaling pathway (e.g., vismodegib, sonidegib, itraconazole) topically (except as topical treatment to anatomical
    areas other than the face) or systemically within 2 months prior to the Screening and Baseline Visit.
    d. Photodynamic therapy (PDT) except to localized non-facial, individual BCCs within 2 months prior to the Screening and Baseline Visit.
    2. The subject has a known hypersensitivity to any of the ingredients in the study IP formulation.
    3. The subject is unable or unwilling to make a good faith effort to return to the study site for all study visits and tests.
    4. The subject has current, recent (within five half lives of the experimental drug or if half life not known, within the past 6 months prior to the Screening Visit), or planned participation in an experimental drug study (excluding Study 926-301) while enrolled in this study.
    5. The subject is a WOCBP who is unwilling or unable to comply with pregnancy prevention measures.
    6. The subject is pregnant or breastfeeding.
    7. The subject has any condition or situation which, in the Investigator’s opinion, may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject’s participation in the study. This may include a history of other skin conditions (e.g., severe facial eczema) or diseases, metabolic dysfunction, physical examination (PE) findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications.
    1. El sujeto ha usado un tratamiento tópico facial o tratamientos sistémicos que podrían interferir con la evaluación del PEI del estudio. Entre estos están el uso de lo siguiente:
    a. 5-fluorouracilo, imiquimod o mebutato de ingenol (excepto como tratamiento tópico en áreas anatómicas que no sean la cara) sistémicamente o tópicamente en la piel dentro de los 2 meses anteriores a la visita de selección e inicial.
    b. Quimioterapia sistémica dentro de 1 año antes de la visita de selección y visita inicial.
    c. Inhibidores conocidos de la vía de señalización de Hedgehog (por ejemplo, vismodegib, sonidegib, itraconazol) tópicamente (excepto como tratamiento tópico para áreas anatomicas que no sean la cara) o sistémicamente dentro de los 2 meses previos a la visita de selección y visita inicial.
    d. Terapia fotodinámica (TFD), excepto para CBC individuales no faciales localizados dentro de los 2 meses previos a la visita de selección y visita inicial.
    2. El sujeto tiene una hipersensibilidad conocida a cualquiera de los ingredientes en la formulación de PEI del estudio.
    3. El sujeto no puede o no quiere hacer un esfuerzo de buena fe en regresar al centro de estudio para todas las visitas y exámenes de estudio.
    4. El sujeto participa, ha participado recientemente (en las cinco semividas del fármaco experimental o, si se desconoce la semivida, en los 6 meses previos a la visita de selección) o tiene previsto participar (mientras se encuentra inlcuido en este estudio) en un estudio con un fármaco experimental (excepto el estudio 301).
    5. El sujeto es una mujer con capacidad de quedarse embarazada que no se muestra dispuesta a cumplir con las medidas de prevención del embarazo o no puede cumplirlas.
    6. La sujeto está embarazada o en periodo de lactancia.
    7. El sujeto tiene cualquier condición o situación que, en opinión del investigador, puede poner al sujeto en un riesgo significativo, podría confundir los resultados del estudio o podría interferir significativamente con la participación del sujeto en el estudio. Esto puede incluir un historial de otras afecciones de la piel (p. Ej., Eccema facial grave) o enfermedades, disfunción metabólica, hallazgos del examen físico (EP) o hallazgos de laboratorio clínico que den sospechas razonables de una enfermedad o afección que contraindique el uso de un medicamento en investigación o que podría afectar la interpretación de los resultados del estudio o hacer que el sujeto tenga un alto riesgo de complicaciones del tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    The number of facial BCCs removed by surgery is considered an appropriate study endpoint as surgery has significant morbidity in Gorlin Syndrome (e.g., scarring, functional loss of eyelid, nose, ear).
    El número de CBC faciales eliminados mediante cirugía se considera un criterio de valoración apropiado del estudio, ya que la cirugía tiene una morbilidad significativa en el síndrome de Gorlin (por ejemplo, cicatrización, pérdida funcional del párpado, nariz, oído).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At all quarterly visits
    En todas las visitas trimestrales
    E.5.2Secondary end point(s)
    The efficacy endpoints are as follows:
    1. The number of facial BCCs removed by surgery (per Investigator determination) and histologically verified as BCC; from Baseline to Month 12
    2. The number of facial BCCs removed by surgery (per Investigator determination) and histologically verified as BCC; from Baseline to Month 6.
    3. The number of facial BCCs removed by surgery (per Investigator determination) from Baseline to Month 12.
    4. The number of facial BCCs removed by surgery (per Investigator determination) from Baseline to Month 6.
    5. Change from Baseline to Month 12 in the total number of facial lesions suspicious for BCC
    6. Count of facial lesions suspicious for BCC over time
    7. aBCCdex change in lesion score from Baseline to Month 12
    Los puntos finales de eficacia son los siguientes:
    1. El número de CBC faciales eliminados mediante cirugía (según la determinación del investigador) y verificados histológicamente como CBC; desde la Visita Inicial hasta el Mes 12
    2. El número de CBC faciales eliminados mediante cirugía (según la determinación del investigador) y verificados histológicamente como CBC; desde la Visita Inicial hasta el Mes 6.
    3. El número de CBC faciales eliminados mediante cirugía (según la determinación del investigador) desde la Visita Inicial hasta el Mes 12.
    4. El número de CBC faciales eliminados mediante cirugía (según la determinación del investigador) desde la Visita Inicial hasta el Mes 6.
    5. Cambiar de la Visita Inicial al Mes 12 en el número total de lesiones faciales sospechosas de CBC.
    6. Recuento de lesiones faciales sospechosas de CBC a lo largo del tiempo.
    7. Cambio de aBCCdex en la puntuación de la lesión desde la Visita Inicial hasta el Mes 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see section E.5.2
    Por favor ver sección E.5.2
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Denmark
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    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
    Ultima visita del último paciente
    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 months10
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days16
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 87
    F.4.2.2In the whole clinical trial 200
    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)
    All subjects should return to their personal physicians to resume standard of care for their condition.
    Todos los sujetos deben regresar a sus médicos personales para reanudar la atención estándar para su condición.
    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 Decision2020-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-07-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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