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    Summary
    EudraCT Number:2013-002134-21
    Sponsor's Protocol Code Number:AP26113-13-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-29
    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 number2013-002134-21
    A.3Full title of the trial
    A Randomized Phase 2 Study of AP26113 in Patients with ALK-positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated with Crizotinib
    Estudio de fase 2, aleatorizado, con AP26113 en pacientes con cáncer de pulmón no microcítico (CPNM) ALK-positivo tratados previamente con crizotinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Non-Small Cell Lung Cancer (NSCLC) whose disease has progressed on therapy with Crizotinib
    Cáncer de pulmón no microcítico (CPNM) cuya enfermedad ha progresado durante el tratamiento con crizotinib.
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberAP26113-13-201
    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 SponsorARIAD Pharmaceuticals, 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 supportARIAD Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationARIAD Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointBao Le
    B.5.3 Address:
    B.5.3.1Street Address26 Landsdowne Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02319
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16175037168
    B.5.6E-mailbao.le@ariad.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 nameAP26113
    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 INNAP26113
    D.3.9.1CAS number 1197953-54-0
    D.3.9.2Current sponsor codeAP26113
    D.3.9.4EV Substance CodeSUB32682
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 ALK-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
    Pacientes con cáncer de pulmón no microcítico (CPNM) ALK positivo, localmente avanzado o metastásico.
    E.1.1.1Medical condition in easily understood language
    metastatic or locally advanced non-small cell lung cancer
    Cáncer de pulmón no microcítico metastásico o localmente avanzado.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine the efficacy of AP26113, as evidenced by objective response rate, in patients with ALK-positive locally advanced or metastatic NSCLC whose disease has progressed on therapy with crizotinib. Two dosing regimens will be tested.
    El objetivo principal del estudio es determinar la eficacia del AP26113, medida mediante la tasa de respuesta objetiva, en pacientes con CPNM ALK positivo, localmente avanzado o metastásico, con progresión de la enfermedad durante el tratamiento con crizotinib. Se estudiarán dos regímenes posológicos.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study (for each dosing regimen) are:
    1. To further characterize the efficacy of AP26113 in patients with
    ALK-positive, locally advanced or metastatic NSCLC whose disease has
    progressed on therapy with crizotinib, as shown by disease control rate, time to/duration of response, progression-free survival (PFS), overall survival (OS), and time on treatment.
    2. To assess CNS response and PFS, per RECIST v1.1, in those patients who have active brain metastases.
    3. To assess the safety and tolerability of AP26113 in study patients.
    4. To measure steady-state plasma levels of AP26113 for use in population PK modeling.
    5. To assess patient-reported symptoms and health-related quality of life (HRQoL) with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 (v3.0).
    Ppara cada régimen posológico son:
    1. Caracterizar mejor la eficacia del AP26113 en pacientes con CPNM ALK positivo, localmente avanzado o metastásico, con progresión de la enfermedad durante el tratamiento con crizotinib, medida mediante la tasa de control de la enfermedad, el tiempo hasta la respuesta/duración de la respuesta, la supervivencia sin progresión (SSP), la supervivencia global (SG) y el tiempo en tratamiento
    2. Evaluar la respuesta en el SNC y la SSP, según RECIST v1.1, en los pacientes con metástasis cerebrales activas
    3. Evaluar la seguridad y la tolerabilidad del AP26113 en los pacientes del estudio
    4. Medir los niveles plasmáticos de AP26113 en estado de equilibrio para su uso en la elaboración de un modelo de farmacocinética poblacional
    5. Evaluar los síntomas comunicados por el paciente y la calidad de vida relacionada con la salud mediante el Cuestionario de Calidad de Vida de la European Organisation for Research and Treatment of Cancer (EORTC)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients must meet all the following eligibility criteria for study entry:
    1. Have histologically or cytologically confirmed locally advanced or
    metastatic NSCLC that is ALK+.
    2. Must meet one of the following two criteria:
    a. Have documented ALK rearrangement by a positive result from the
    Vysis® ALK Break-Apart fluorescence in situ hybridization (FISH)
    Probe Kit; or
    b. Have documented ALK positivity by a different test and tissue available for the Vysis® FISH test. Tissue should be derived preferably from abiopsy taken after progression with crizotinib. If such a sample is not available, testing may be performed with archived tumor tissue.
    3. Had progressive disease while on crizotinib, as assessed by the investigator or treating physician.
    4. Received crizotinib as the last therapy, within 30 days of the first dose of AP26113. This criterion may be met by reintroduction of crizotinib after intervening therapy. If crizotinib was reintroduced, documented progression on the most recent regimen of crizotinib must have occurred.
    8. Are a male or female patient ?18 years old.
    Todos los pacientes deberán cumplir todos los criterios de elegibilidad siguientes:
    1. Presentar un CPNM localmente avanzado o metastásico confirmado histológica o citológicamente, que sea ALK+.
    2. Deben cumplir uno de los dos criterios siguientes:
    a. Tener una reordenación de ALK, demostrada mediante un resultado positivo con el Vysis® ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit, o
    b. Tener positividad de ALK documentada mediante una prueba diferente y tejido disponible para la prueba FISH Vysis®. El tejido debe proceder preferiblemente de una biopsia obtenida después de la progresión con crizotinib. Si no se dispusiera de dicha muestra, la prueba podrá efectuarse en una muestra de tejido de archivo.
    3. Haber presentado enfermedad progresiva durante el tratamiento con crizotinib, en su evaluación por el investigador o por el médico que trataba al paciente.
    4. Haber recibido crizotinib como último tratamiento, en el plazo de los 30 días anteriores a la primera dosis de AP26113. Este criterio podría satisfacerse mediante la reintroducción de crizotinib después del tratamiento interpuesto. Si se hubiera reintroducido el crizotinib, deberá haberse producido una progresión documentada con el régimen más reciente de crizotinib.
    8. Ser hombre o mujer >/= 18 años de edad
    E.4Principal exclusion criteria
    Patients meeting any of the criteria below are ineligible for the study:
    1. Received any prior ALK-targeted TKI other than crizotinib.
    2. Received crizotinib within 3 days of the first dose of AP26113 (Day 1, Cycle1).
    3. Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days, except SRS or stereotactic body radiosurgery.
    4. Received monoclonal antibodies or had major surgery within 30 days of the first dose of AP26113 (Day 1, Cycle 1).
    No serán elegibles para el estudio los pacientes que cumplan cualquiera de los siguientes criterios:
    1. Han recibido antes cualquier TKI dirigido frente a ALK distinto del crizotinib.
    2. Han recibido crizotinib en el plazo de los 3 días anteriores a la primera dosis de AP26113 (Día 1, Ciclo 1).
    3. Han recibido quimioterapia citotóxica, agentes en fase de investigación o radioterapia en el plazo de los 14 últimos días, excepto RCE o radiocirugía corporal estereotáctica.
    4. Han recibido anticuerpos monoclonales o han sido sometidos a cirugía mayor en el plazo de los 30 días anteriores a la primera dosis de AP26113 (Día 1, Ciclo 1).
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    Confirmed Objective Response Rate (ORR), as assessed by the investigator, per RECIST v1.1
    Criterio principal de valoración:
    La tasa de respuesta objetiva (TRO) confirmada, en su evaluación por el investigador, según RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8 weeks (from Day 1 of Cycle 3 through Cycle 15; every 3 cycles thereafter)
    Cada 8 semanas (a partir del Día 1 de del Ciclo 3 hasta el Ciclo 15; y, luego, cada 3 ciclos)
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    1. Confirmed ORR, as assessed by a central independent review
    committee (IRC), per RECIST v1.1
    2. CNS response (ORR and PFS, per RECIST v1.1, in patients who have
    active brain metastases)
    3. Time to response
    4. Duration of response
    5. Time on treatment
    6. Disease control rate (the percentage of patients with best response of complete response [CR], PR, or SD), per RECIST v1.1
    7. Progression Free Survival (PFS)
    8. Overall Survival (OS)
    9. Safety and tolerability
    10. Steady-state plasma level of AP26113 for use in population PK
    modeling
    11. Patient-reported symptoms of lung cancer and HRQoL scores,
    assessed with the EORTC QLQ-C30 (v3.0)
    Criterios secundarios:
    1. TRO confirmada, en su evaluación por un comité central de revisión independiente (CRI), según RECIST v1.1
    2. Respuesta en el SNC (TRO y SSP, según RECIST v1.1, en pacientes con metástasis cerebrales activas)
    3. Tiempo hasta la respuesta
    4. Duración de la respuesta
    5. Tiempo en tratamiento
    6. Tasa de control de la enfermedad (porcentaje de pacientes con una mejor respuesta calificada como respuesta completa [RC], respuesta parcial [RP] o enfermedad estable [EE], según RECIST v1.1)
    7. Supervivencia sin progresión (SSP)
    8. Supervivencia global (SG)
    9. Seguridad y tolerabilidad
    10. Niveles plasmáticos de AP26113 en estado de equilibrio para su uso en la elaboración de un modelo de farmacocinética poblacional
    11. Síntomas de cáncer de pulmón comunicados por el paciente y puntuaciones de calidad de vida relacionada con la salud según el QLQ-C30 (v3.0) de la EORTC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Collection of secondary endpoints will continue for 2 years after the last
    patient enrolls into the study.
    La recogida de criterios secundarios de valoración continuará durante 2 años después de la inclusión en el estudio del último paciente
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 Yes
    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 trial2
    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 EEA55
    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
    Canada
    Australia
    Hong Kong
    Korea, Republic of
    Singapore
    Switzerland
    United States
    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
    The trial will end when all patients have discontinued from the trial, but
    no longer than 2 years after the last patient enrolls into the study.
    El estudio finalizará cuando todos los pacientes se hayan retirado del ensayo,pero no más de 2 años después de que el último paciente sea incluido en el estudio.
    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 years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 109
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 109
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 218
    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)
    Patients will be allowed to receive study drug beyond this period until
    disease progression or they discontinue treatment for other reasons.
    Los pacientes podrán continuar con el fármaco del estudio después de este periodo hasta la progresión de la enfermedad o el abandono del tratamiento por otras razones.
    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 Opinion2014-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-27
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