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    Summary
    EudraCT Number:2017-004822-13
    Sponsor's Protocol Code Number:GECP17/04
    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:2018-06-27
    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 number2017-004822-13
    A.3Full title of the trial
    An Open Label Phase II Study of Tipifarnib in Advanced Squamous Non-small Cell Lung Cancer with HRAS mutations
    Estudio Fase II, abierto para el tratamiento de Tipifarnib en el cáncer de pulmón avanzado no microcítico de células escamosas con mutaciones HRAS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to evaluate the response rate of tipifarnib in patients with locally advanced unresectable or metastasic, relapsed and/or refractory, squamous non-small cell lung cancer with HRAS mutations
    Un estudio de investigación para evaluar la tasa de respuesta de tipifarnib en pacientes con cáncer de pulmón no microcítico escamoso localmente avanzado irresecable o metastásico, recidivante y/o refractario al tratamiento con mutaciones de HRAS
    A.3.2Name or abbreviated title of the trial where available
    THoMAS: Tipifarnib in Advanced Squamous NSCLC with HRAS MutAtionS
    THoMAS: Tipifarnib en cáncer de pulmón no microcítico escamoso con mutaciones de HRAS
    A.4.1Sponsor's protocol code numberGECP17/04
    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 SponsorSpanish Lung Cancer Group (SLCG/GECP)
    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 supportSpanish Lung Cancer Group (SLCG/GECP)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpanish Lung Cancer Group (SLCG/GECP)
    B.5.2Functional name of contact pointEva Pereira
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Meridiana 358 6ª Planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34934302006
    B.5.5Fax number+34934191768
    B.5.6E-mailepereira@gecp.org
    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 number900
    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
    squamous non-small cell lung cancer (SQ-NSCLC)
    Pacientes con cáncer de pulmón no microcítico escamoso localmente avanzado irresecable o metastásico
    E.1.1.1Medical condition in easily understood language
    Squamous non small cell lung cancer harbouring HRAS mutation
    Pacientes con cancer de pulmon no microcitico escamoso con mutación HRAS
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025044
    E.1.2Term Lung cancer
    E.1.2System Organ Class 100000004864
    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 antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations. This objective will be evaluated in the treatment phase of the study.
    Determinar la actividad antitumoral en los términos de la tasa de respuesta objetiva de tipifarnib en sujetos con cáncer de pulmón no microcítico escamoso (SQ-NSCLC) localmente avanzado no resecable o metastásico, recidivante y/o refractario con mutaciones HRAS
    E.2.2Secondary objectives of the trial
    - To determine the frequency of HRAS mutations in squamous non-small cell lung cancer (SQ-NSCLC). This objective will be evaluated in the pre-screening phase of the study
    - Safety and tolerability of tipifarnib in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations. This objective will be evaluated in the treatment phase of the study
    - Determinar la frecuencia de mutaciones HRAS en cáncer de pulmón no microcítico escamoso. Este objetivo será evaluado in la fase de pre-screening del estudio.
    - La seguridad y la tolerabilidad de tipifarnib en sujetos con cáncer de pulmón no microcítico escamoso (SQ-NSCLC) localmente avanzado no resecable o metastásico, recidivante y/o refractario con mutaciones HRAS. Este objetico será evaluado en la fase de tratamiento del estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (SQ-NSCLC) for which there is no curative therapy available.
    - Relapsed of disease (progressive disease) or is refractory to one or more prior therapies. In the case of therapy received in the adjuvant or neo-adjuvant setting, relapse must have occurred within 12 months to be considered prior therapy.
    - A tumor that carries a missense HRAS mutation.
    - Consent to provide tumor slides (or tumor tissue blocks) for biomarker evaluation.
    - Subject has measurable disease according to RECIST v1.1.
    - At least 2 weeks since the last systemic therapy regimen prior to enrolment.
    - At least 2 weeks since last radiotherapy. If radiation was localized to the only site of measurable disease, there must be documentation of disease progression of the irradiated site. Subjects must have recovered from all acute toxicities from radiotherapy.
    - ECOG performance status of 0 or 1.
    - Carcinoma no microcítico de pulmón comprobado por el análisis histológico o citológico para el cual no hay terapia curativa disponible.
    - Recaída de la enfermedad (enfermedad progresiva) o ser refractario a una o más terapias anteriores. En el caso de la terapia recibida en el entorno adyuvante o neoadyuvante, la recaída debe haber ocurrido dentro de los 12 meses para considerarse terapia previa.
    - Haber tumor con mutación HRAS.
    - Consentimiento para proporcionar láminas tumorales (o bloques de téjido tumoral) para la evaluación de biomarcadores.
    - Tener una enfermedad mensurable de acuerdo con RECIST v1.1.
    - Al menos 2 semanas desde la última terapia sistémica antes de la inscripción.
    - Al menos 2 semanas desde la última radioterapia. Si la radiación fue localizada en un único lugar de la enfermedad mensurable, debería haber documentación sobre la progresión de la enfermedad en el lugar irradiado. Los sujetos deberán haberse recuperado de todas las toxicidades de la radioterapia.
    - Categoría funcional ECOG de 0 o 1.
    E.4Principal exclusion criteria
    - Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
    - The subject has legal incapacity or limited legal capacity.
    - Significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.
    - Enfermedad concomitante o condición que podría interferir en la realización del estudio, o que en opinión del investigador, podría suponer un riesgo para el sujeto del estudio.
    - Sujeto incapacitado legalmente o tener limitada su capacidad.
    - Estado mental significativamente alterado que limitaría la comprensión o la prestación del consentimiento informado y el cumplimiento de los requisitos de este protocolo. Falta de voluntad o incapacidad para cumplir con el protocolo por cualquier motivo.
    E.5 End points
    E.5.1Primary end point(s)
    Response assessments according to RECIST 1.1
    Evaluaciones de respuesta según RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Will be evaluated in the treatment phase of the study
    Será evaluado en la fase de tratamiento del estudio
    E.5.2Secondary end point(s)
    - Molecular analyses of tumor and/or cell free DNA samples
    - Treatment-emergent adverse events (TEAE) and SAEs evaluated according to NCI CTCAE v.4.03
    - Análisis molecular de muestras de ADN libres de tumor y/o células
    - Acontecimientos adversos emergentes del tratamiento (TEAE) y SAE evaluados de acuerdo con NCI CTCAE v.4.03
    E.5.2.1Timepoint(s) of evaluation of this end point
    - The first secondary end point will be evaluated in the pre-screening phase of the study
    - The second secondary end point will be evaluated in the treatment phase of the study
    - El primer end point secundario será evaluado en la fase de pre-screening del estudio
    - El segundo end point secundario será evaluado en la fase de tratamiento del 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 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) 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 concerned30
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months0
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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.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
    No hay planes preestablecidos
    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 Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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