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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   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:2016-001396-69
    Sponsor's Protocol Code Number:KO-TIP-002
    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:2016-08-05
    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 number2016-001396-69
    A.3Full title of the trial
    An Open Label Phase II Study of Tipifarnib in Subjects with Relapsed or Refractory Peripheral T-Cell LymphomaLymphoma
    Estudio fase II abierto de Tipifarnib en pacientes con recaída o refractarios a linfoma de células T periférico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to find out whether tipifarnib is safe and effective for the treatment of a lymphoma in the cases of previous treatment have failed.
    Un estudio de investigación para averiguar si tipifarnib es seguro y eficaz para el tratamiento de un linfoma en los casos de tratamientos previos han fracasado.
    A.4.1Sponsor's protocol code numberKO-TIP-002
    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 SponsorKura Oncology 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 supportKURA ONCOLOGY, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKura Oncology, Inc
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address55 Cambridge Parkway, Suite 101
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number001617588-3747
    B.5.6E-mailkaren@kuraoncology.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTipifarnib
    D.3.2Product code R115777
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNtipifarnib
    D.3.9.1CAS number 192185-72-1
    D.3.9.2Current sponsor codeR115777
    D.3.9.3Other descriptive nameTIPIFARNIB
    D.3.9.4EV Substance CodeSUB22236
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Subjects with Relapses and Refractory Peripheral T-Cell Lymphoma
    Sujetos con recaída o refractarias a limfoma de células T periférico
    E.1.1.1Medical condition in easily understood language
    lymphoma in the cases of previous treatment have failed
    Limfoma en el caso que los tratamientos anteriores hayan fallado
    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 determine the anti tumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with relapsed or refractory peripheral T-cell Lymphoma (PTCL)
    Determinar la actividad antitumoral en términos de tasa respuesta objeta (TRO) al tipifarnib en pacientes con recaída o refractarios a limfoma de células T periférico.
    E.2.2Secondary objectives of the trial
    To determine the anti tumor activity in terms of progression free survival ( PFS) and duration of response (DOR) of tipifarnib in subjects with relapsed or refractory PTCL
    Determinar la actividad antitumoral en términos de progresión libre de enfermedad (PFS) y duración de la respuesta (ORR) al tipifarnib en pacientes refractarios o con recaída a limfoma de células T periférico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject has a diagnosis of PTCL according to the most recent edition of the World Health Organization (WHO) Classification of Tumors of Hematopoietic or Lymphoid Tissues as follows:
    a. Anaplastic large cell lymphoma (ALCL), ALK positive
    b. ALCL, ALK negative
    c. Angioimmunoblastic T-cell lymphoma (AITL)
    d. Enteropathy-associated T-cell lymphoma
    e. Extranodal natural killer (NK) T-cell lymphoma, nasal type
    f. Hepatosplenic T-cell lymphoma
    g. Peripheral T-cell lymphoma, no otherwise specified (NOS)
    h. Subcutaneous panniculitis-like T-cell lymphoma
    El sujeto tiene un diagnóstico de linfoma de células T periférico (PTCL) de acuerdo con la edición más reciente de la Organización Mundial de la Salud (OMS) de los tumores de tejidos linfoides o hematopoyéticos de la siguiente manera:
    a. Linfoma anaplásico de células grandes (LACG), ALK positivo
    b. LACG, ALK negativo c. Linfoma angioinmunoblástico de células T (AITL)
    d. Linfoma de células T asociado a enteropatía
    e. Linfoma extranodal de células T y de células (NK), tipo nasal
    f. Linfoma Hepatosplénico de células T
    g. Linfoma periférico de células T, sin alguna otra caracterización
    h. Linfoma de apariencia paniculítica subcutáneo de células T.
    E.4Principal exclusion criteria
    1. Diagnosis of any of the following:
    a. Precursor T-cell lymphoma or leukemia b. Adult T-cell lymphoma/leukemia (ATLL)
    c. T-cell prolymphocytic leukemia
    d. T-cell large granular lymphocytic leukemia
    e. Primary cutaneous type anaplastic large cell lymphoma
    Page 6 of 58
    f. Mycosis fungoide/Sezary syndrome
    Diagnóstico de alguna de las siguientes:

    a. Precursor de linfoma de células T o leucemia
    b. Linfoma/Leucemia de células T del adulto
    c. Leucemia prolinfocitica de células T
    d. Leucemia linfocítica granular de células T grandes
    e. Limfoma anaplásico de células grandes, tipo cutáneo
    f. Micosis fungoide/ Síndrome Sézary
    E.5 End points
    E.5.1Primary end point(s)
    Response assessments determined by IWC and/or mSWAT
    Enfermedad medible secos IWC y/o mSWAT
    E.5.1.1Timepoint(s) of evaluation of this end point
    At screening (4 weeks before the first study drug administration), at the end of cycle 2, 4, 6 and then approximately 9 week cycle 9, 12, 15, and other thereafter until disease progression
    Durante la visita selección ( 4 semanas antes de la primera dosis), al final del ciclo 2, 4 y 6 , luego aproximadamente cada 9 semanas , ciclo 9, 12, 15 y siguientes hasta progresión enfermedad
    E.5.2Secondary end point(s)
    SAEs evaluated according to NCI CTCAE v.4.03
    Acontecimientos Adversos graves evaluados según CTCAE v4.03
    E.5.2.1Timepoint(s) of evaluation of this end point
    Comprehensive assessment of any apparent toxicity experienced by the subject will be performed throughout the course of the trial (at each study visit and as clinically needed), from the time of the subject's signature of informed consent until 30 days from the final administration of the trial treatment or immediately before initiation of any other anticancer therapy, whichever comes first
    Evaluación de cualquier toxicidad aparente ocurrida al sujeto durante el transcurso del ensayo ( en cada visita de estudio y como sea necesario clínicamente), desde la firma del consentimiento informado hasta 30 días después de la última dosis de tratamiento, o inmediatamente antes de cualquier otro tratamiento antitumoral
    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 Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Spain
    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
    The end of this clinical study is defined as the day when the last remaining study subject in the trial completes the last Follow-up assessment no later than 12 months after the last study subject is enrolled in the study. Provisions will be made for the continuation of study treatment in patients who demonstrate objective response or disease stabilization and manageable toxicity beyond the end of the study, e.g. a single patient treatment protocol
    El final del ensayo clínico se define como el día en que el último sujeto completa la visita de seguimiento no después de 12 meses después que el último sujeto del estudio haya sido incluido en el estudio. Se ha considerado la continuidad del tratamiento del estudio en los pacientes que demuestren respuesta objetiva o estabilización de la enfermedad y toxicidad manejable más allá del final del estudio, por ejemplo, como un único protocolo de tratamiento al 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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 30
    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)
    None
    Ninguno
    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 Decision2016-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-05
    P. End of Trial
    P.End of Trial StatusOngoing
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