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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:2015-001722-42
    Sponsor's Protocol Code Number:GEINO-13
    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:2015-06-01
    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 number2015-001722-42
    A.3Full title of the trial
    Phase II, pilot, open label, multicenter and prospective clinical trial to evaluate the safety and activity of Palbociclib (PD0332991), a cyclin-dependent kinase 4/6 (CDK4 and CDK6) inhibitor, in patients with recurrent anaplasic oligodendroglioma or oligoastrocytome with the activity of the RB protein conserved
    Ensayo Clínico Fase II piloto, abierto, multicéntrico y prospectivo para evaluar la
    seguridad y eficacia de Palbociclib (PD0332991), un inhibidor de las ciclinas dependientes de kinasas 4 y 6 (CDK4 y CDK6), en pacientes con Oligodendroglioma u Oligoastrocitoma Anaplásico recurrente con preservación de la actividad de la proteína RB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety and activity of Palbociclib (PD0332991), in patients with recurrent anaplasic oligodendroglioma or oligoastrocytome with the activity of the RB protein conserved
    Estudio para evaluar la seguridad y eficacia de Palbociclib (PD0332991), en pacientes con Oligodendroglioma u Oligoastrocitoma Anaplásico recurrente con preservación de la actividad de la proteína RB
    A.4.1Sponsor's protocol code numberGEINO-13
    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 SponsorGRUPO ESPAÑOL DE INVESTIGACIÓN EN NEUROONCOLOGGÍA (GEINO)
    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 supportGRUPO ESPAÑOL DE INVESTIGACIÓN
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMARKETING FARMACÉUTICO & INVESTIGACIÓN CLÍNICA
    B.5.2Functional name of contact pointMARKETING FARMACÉUTICO & INVESTIGAC
    B.5.3 Address:
    B.5.3.1Street AddressSecretari Coloma, 64-68
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08024
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934344412
    B.5.5Fax number0034932531168
    B.5.6E-mailinvestigacion@mfar.net
    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 namePalbociclib
    D.3.2Product code PD0332991
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPalbociclib
    D.3.9.3Other descriptive namePALBOCICLIB
    D.3.9.4EV Substance CodeSUB130860
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    Recurrent anaplasic oligodendroglioma or oligoastrocytome
    Oligodendroglioma o oligoastrocitoma anaplásico recurrente
    E.1.1.1Medical condition in easily understood language
    Recurrent cerebral cancer
    Cáncer cerebral recurrente
    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
    To assess the progression free survival at 6 months
    Evaluar la supervivencia libre de progresión (SLP) a los seis meses (SLP6m)
    E.2.2Secondary objectives of the trial
    To determine the safety and tolerability
    To determine the anti-tumoral response following the RANO criteria
    To assess the overall survival (OS)
    To assess the response duration in patients with objective response
    To assess changes in glucocorticoid use
    To assess change in neurological status
    To determine if some biomarkers have any relation with PFS and OS
    Evaluar la seguridad y tolerabilidad
    Evaluar la respuesta antitumoral según los criterios RANO
    Evaluar la Supervivencia Global (SG)
    Evaluar la duración de la respuesta en pacientes con una respuesta objetiva.
    Evaluar cambios en el uso de glucocorticoides.
    Evaluar cambios en el estado neurológico
    Evaluar si los biomarcadores tienen relación con la SLP y SG
    Evaluar si los biomarcadores tienen relación con la tasa de respuestas
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A substudy has been designed:
    - Substudy in tumor sample, version 1.0, date 27March2015
    Objective: To associate the activity of the drug and some biomarkers
    Se llevarán a cabo el siguiente subestudio:
    - Subestudio traslacional en tejido, versión 1.0 del 27/03/2015
    Objetivo: Evaluar la asociación entre la actividad del fármaco y diferentes biomarcadores
    E.3Principal inclusion criteria
    1. Patients with anaplasic oligodendroglioma or oligoastrocytome histologically confirmed
    2. Patients in relapse after radiotherapy and one or two lines of chemotherapy.
    3. All patients have to present possitivity in immunohistochemical study for the RB protein in the tumor samples sent to the central lab.
    4. The cases must have 10 slides or a tumor block available from a biopsy or cirurgy.
    5. All patients have to show disease progression in a cerebral nuclear magnetic resonance.
    6. Interval of at least one week between the previous intracranial biopsy and the inclusion.
    7. Interval of at least 12 weeks between radiotherapy and the inclusion, unless:
    a) Recurrent tumor confirmed histologically
    b) recurrency showed in the NMR out of radiotherapy
    8. Stable or decreasing dose of corticoids during the five days prior to the inclusion
    1. Pacientes con oligodendroglioma anaplásico u oligoastrocitoma anaplásico según clasificación WHO (OMS) y confirmado histológicamente.
    2. Pacientes en situación de recaída tras haber recibido radioterapia y una o dos líneas de quimioterapia.
    3. Todos los pacientes deben presentar positividad en el estudio inmunohistoquímico para la proteína RB en el material tumoral analizado por el laboratorio central (Laboratorio de Neuropatología. Hospital Universitario 12 de Octubre).
    4. Los casos deben tener al menos 10 cristales (laminillas sin tinción) o un bloque de tejido incluido en parafina disponible a partir de una biopsia previa o cirugía (muestras de tumor archivadas previamente).
    5. Todos los pacientes deben mostrar progresión de enfermedad en una resonancia magnética del cerebro según la definición establecida en los Criterios RANO.
    6. Intervalo de al menos una semana entre biopsia intracraneal previa, cicatrizada adecuadamente, y la inclusión.
    7. Intervalo de al menos de 12 semanas entre radioterapia previa y la inclusión, a menos que sea:
    a) confirmación histopatológica de tumor recurrente, o
    b) recurrencia en la RM fuera del campo de radioterapia.
    8. Dosis estable o decreciente de corticoides durante los cinco días previos a la inclusión en el estudio.
    E.4Principal exclusion criteria
    1. Presence of meningeal carcinomatosis disseminated
    2. Concomitant treatment with other investigational products
    3. Any kind of cirugy in the previous 2 weeks
    4. Presence of any gastrointestinal alteration clinically significant
    5. In the 7 days prior to the begining of the treatment, to have recived a treatment with:
    - Drugs inhibitor of the CYP3A4
    - Durgs inductors of the CYP3A4
    - Durgs that extends the QT interval
    6. QTc interval >480 msec, familiar history or personal of QT large Syndrome, QT short Siyndrome, Brugada syndrome, QTc extension or Torsade de Pointes history
    7. Electrolitic alteration that may afect to the QTc interval
    1. Presencia de carcinomatosis meníngea diseminada.
    2. Tratamiento concomitante con otros agentes de investigación.
    3. Cirugía de cualquier tipo (no incluye los procedimientos de diagnóstico de menor importancia tales como biopsia de ganglios linfáticos) en las 2 semanas previas a las evaluaciones basales de la enfermedad, o presencia de efectos secundarios de procedimientos previos.
    4. Presencia de cualquier anomalía gastrointestinal clínicamente significativa
    5. Haber recibido en los 7 días previos al inicio del tratamiento cualquiera de los siguientes tratamientos farmacológicos:
    - Fármacos inhibidores potentes de CYP3A4
    - Fármacos inductures de CYP3A4
    - Fármacos que aumentan el intervalo QT.
    6. Intervalo QTc >480 msec (basado en la media del valor tomado en tres registros de ECG), historia familiar o personal de síndrome de QT largo, síndrome de QT corto, síndrome de Brugada, prolongación de QTc o antecedente de Torsade de Pointes.
    7. Trastorno electrolítico que pueda afectar al intervalo QTc (ej hipocalcemia, hipokaliemia e hipomagnesemia).
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients that have or not relapsed to the study treatment at 6 months after the begining of the treatment.
    Porcentaje de pacientes que han recaído/no recaído al tratamiento en estudio a los 6 meses de iniciado el mismo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    To determine the safety and tolerability
    To determine the anti-tumoral response following the RANO criteria
    To assess the overall survival (OS)
    To assess the response duration in patients with objective response
    To assess changes in glucocorticoid use
    To assess change in neurological status
    To determine if some biomarkers have any relation with PFS and OS
    Evaluar la seguridad y tolerabilidad
    Evaluar la respuesta antitumoral según los criterios RANO
    Evaluar la Supervivencia Global (SG)
    Evaluar la duración de la respuesta en pacientes con una respuesta objetiva.
    Evaluar cambios en el uso de glucocorticoides.
    Evaluar cambios en el estado neurológico
    Determinar si los biomarcadores tienen relación con la SLP y la SG
    E.5.2.1Timepoint(s) of evaluation of this end point
    Duration of the trial Duration of Response (DR) - duration of the trial Overall Survival (OR) - duration of the trial Safety - The safety period includes the time
    between the date of signing the informed consent until 28 days after the last dose of study drug
    Durante todo el ensayo Duración de la respuesta (DR) - Durante todo el ensayo Supervivencia global (SG) - Durante todo el ensayo Seguridad - El período de seguridad comprende entre la fecha de la firma del consentimiento informado hasta 28 días después de la última dosis del fármaco de estudio.
    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 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 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.8.3 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 concerned10
    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 Yes
    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 years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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)
    At the discretion of the treating physician
    A criterio del médico investigador
    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 Decision2015-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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