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    EudraCT Number:2011-005718-12
    Sponsor's Protocol Code Number:AP26113-11-101
    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:2012-03-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-005718-12
    A.3Full title of the trial
    A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral ALK/EGFR Inhibitor AP26113
    Estudio en fase 1/2 sobre la seguridad, tolerabilidad, farmacocinética y actividad antitumoral preliminar de AP26113, un inhibidor de ALK/EGFR administrado por vía oral
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 Study of the Oral ALK/EGFR Inhibitor AP26113
    En fase 1/2 sobre un inhibidor de ALK/EGFR administrado por vía oral
    A.4.1Sponsor's protocol code numberAP26113-11-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01449461
    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 organisationNexus Oncology Ltd.
    B.5.2Functional name of contact pointAP26113-11-101 Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressRoslin Biocentre
    B.5.3.2Town/ cityRoslin, Midlothian
    B.5.3.3Post codeEH25 9TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44131200 6320
    B.5.5Fax number44131200 6322
    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.3.2Product code AP26113
    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.3.9.2Current sponsor codeAP26113
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Dose Escalation Phase: Histologically confirmed advanced malignancies. All histologies except leukaemia.
    Dose Expansion Phase: Non-small cell lung cancer (NSCLC)
    Fase de aumento escalonado de dosis: Neoplasias malignas avanzadas, confirmadas histológicamente. Todas las histologías, excepto leucemia.
    Fase de ampliación de dosis: Cáncer pulmonar no microcítico (CPNM)
    E.1.1.1Medical condition in easily understood language
    advanced malignancies
    non-small cell lung cancer (NSCLC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10029105
    E.1.2Term Neoplasms malignant site unspecified NEC
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10048683
    E.1.2Term Advanced cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028997
    E.1.2Term Neoplasm malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10027655
    E.1.2Term Miscellaneous and site unspecified neoplasms malignant and unspecified
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety profile of orally administered AP26113 including identification of the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs).
    Determinar el perfil de seguridad de AP26113 administrado por vía
    oral, incluyendo la identificación de la dosis máxima tolerada
    (DMT) y la toxicidad limitante de dosis (TLD).
    E.2.2Secondary objectives of the trial
    1.To determine the recommended phase 2 dose (RP2D) of orally administered AP26113.
    2.To examine the pharmacokinetic (PK) profile of AP26113.
    3.To describe the preliminary anti-tumor activity of AP26113 in NSCLC with ALK gene rearrangement or mutant EGFR activity, and other cancers with abnormal targets.
    4.To perform exploratory analysis including molecular assessments.
    1. Determinar la DRF2 de AP26113 administrado por vía oral.
    2. Evaluar el perfil farmacocinético (FC) de AP26113.
    3. Describir la actividad antitumoral preliminar de AP26113 en el
    CPNM con reordenación del gen ALK o EGFR mutado, así como en
    otras neoplasias malignas con dianas alteradas.
    4. Realizar un análisis exploratorio que incluya evaluaciones
    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. All patients must have tumor tissue available for analysis. If sufficient tissue is not available, patients must undergo a biopsy to obtain adequate samples. Patients with less tissue than required can be enrolled only with prior approval from the Sponsor.
    In the expansion cohorts, for which failure of prior therapy is specified (expansion cohorts 2 and 3), tumor tissue must be obtained following failure of the prior therapy.
    2. Must have measurable disease by RECIST (version 1.1).
    3. Male or female patients >= 18 years old.
    4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
    5. Minimum life expectancy of 3 months or more.
    6. Adequate renal and hepatic function as defined by the following criteria:
    i. Total serum bilirubin <= 2 x upper limit of normal (ULN);
    ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
    <= 2.5 x ULN (or <= 5 x ULN if liver function abnormalities are due to underlying malignancy);
    iii. Serum creatinine < 2 x ULN;
    iv. Serum albumin >= 2 g/dL.
    7. Adequate bone marrow function as defined by the following criteria:
    i. Absolute neutrophil count (ANC) >= 1500/μL;
    ii. Platelets >=75,000/μL;
    iii. Hemoglobin >= 9.0 g/dL.
    8. Normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of <= 450 ms in males or <= 470 ms in females.
    9. For females of childbearing potential, a negative pregnancy test must be documented prior to enrollment.
    10. Female and male patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners throughout study participation.
    11. Signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study.
    12. Willingness and ability to comply with scheduled visits and study procedures.
    Todos los pacientes deberán reunir los siguientes criterios de elegibilidad para poder ser incluidos en el estudio.
    1. Todos los pacientes deberán tener tejido tumoral disponible para su análisis. Los pacientes que no dispongan de tejido suficiente deberán hacerse una biopsia para obtener muestras adecuadas.
    En las cohortes de ampliación, en las que se especifica el fracaso de la terapia previa (cohortes de ampliación 2 y 3), deberá obtenerse tejido tumoral después
    del fracaso de la terapia previa.
    2. Deberán presentar enfermedad evaluable según los criterios RECIST (versión 1.1).
    3. Pacientes (hombres y mujeres) >=18 años de edad.
    4. Grado de actividad ECOG (Eastern Cooperative Oncology Group) de 0 a 2.
    5. Esperanza de vida mínima de 3 meses o más.
    6. Función hepática y renal adecuada, definida según los siguientes criterios:
    i. Bilirrubina total en suero <=2 x límite superior de la normalidad (LSN).
    ii. Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) <=2,5 x LSN (o <=5 x LSN si las alteraciones de la función hepática se deben a la neoplasia maligna subyacente).
    iii. Creatinina sérica <2 x LSN.
    iv. Albúmina sérica >=2 g/dL.
    7. Función adecuada de la médula ósea, definida según los siguientes criterios:
    i. Recuento absoluto de neutrófilos (RAN) >=1500/μL.
    ii. Plaquetas >=75 000/μL.
    iii. Hemoglobina >=9,0 g/dL.
    8. Intervalo QT normal en el electrocardiograma (ECG) de selección, definido como un intervalo QTcF <=450 mseg en hombres o <=470 mseg en mujeres.
    9. En el caso de las mujeres con posibilidad de quedarse
    embarazadas, deberá realizarse una prueba de embarazo que
    resulte negativa antes de la inclusión en el estudio.
    10. A lo largo de todo el estudio, las mujeres y hombres potencialmente fértiles deberán utilizar un método anticonceptivo eficaz con sus parejas.
    11. Consentimiento informado firmado y fechado, que indique que el paciente ha sido informado de todos los aspectos relevantes del estudio.
    12. Voluntad y capacidad para cumplir con las visitas programadas y los procedimientos del estudio.
    E.4Principal exclusion criteria
    Patients are not eligible for participation in the study if they meet or have any of the following exclusion criteria:
    1. Received an investigational agent within 14 days prior to initiating AP26113.
    2. Received systemic anticancer therapy or radiation therapy within 14 days prior to initiating AP26113
    a. Except that for cohorts 3 and 4, EGFR TKI therapy is allowed up to 72 hours
    prior to initiating AP26113.
    3. Major surgery within 28 days prior to initiating AP26113.
    4. Active metastases in the brain or central nervous system (CNS). If present, metastases must be stable for at least 8 weeks as documented by magnetic resonance imaging (MRI) or, in the case of meningeal involvement, by a negative lumbar puncture prior to study entry.
    5. Significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to:
    a. Myocardial infarction, unstable angina and/or congestive heart failure within
    3 months prior to first dose of AP26113;
    b. History of clinically significant (as determined by the treating physician) atrial
    arrhythmia or any ventricular arrhythmia.
    6. Uncontrolled hypertension (Diastolic blood pressure [BP] > 100 mm Hg; Systolic
    > 150 mm Hg).
    7. Prolonged QTcF interval, or being treated with medications known to cause Torsades
    de Pointes (refer to Attachment 4).
    8. Ongoing or active infection. The requirement for IV antibiotics is considered active infection.
    9. Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history.
    10. Pregnant or breastfeeding.
    11. Malabsorption syndrome or other gastrointestinal illness that could affect oral
    absorption of AP26113.
    12. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the drug.
    No serán aptos para participar en el estudio los pacientes que cumplan o presenten cualquiera de los siguientes criterios de exclusión:
    1. Haber recibido un fármaco en investigación en los 14 días previos al inicio de AP26113.
    2. Haber recibido terapia antineoplásica sistémica o radioterapia en los 14 días previos al inicio de AP26113.
    a. A excepción de las cohortes 3 y 4, la terapia con TKI de EGFR está permitida hasta 72 horas antes del inicio de AP26113.
    3. Cirugía mayor en los 28 días previos al inicio de AP26113.
    4. Metástasis activas en el cerebro o el sistema nervioso central (SNC). Si hubiese metástasis presentes, deberán estar estables durante al menos 8 semanas, documentándolo mediante resonancia magnética (RM) o, en caso de afectación meníngea, mediante una punción lumbar negativa antes de la
    inclusión en el estudio.
    5. Enfermedad cardiovascular importante, activa o no controlada, incluyendo específicamente (entre otras):
    a. Infarto de miocardio, angina inestable y/o insuficiencia cardiaca congestiva en los 3 meses previos a la primera dosis de AP26113.
    b. Historial de arritmia ventricular clínicamente significativa (según determinación del médico responsable del tratamiento) o cualquier arritmia
    6. Hipertensión no controlada (tensión arterial [TA] diastólica
    >100 mm Hg y sistólica >150 mm Hg).
    7. Intervalo QTcF prolongado o tratamiento con medicamentos que se sabe causan Torsades de Pointes (véase el Anexo 4).
    8. Infección activa o continuada. La necesidad de antibióticos por vía intravenosa (i.v.) se considera infección activa.
    9. Historial médico conocido de infección por el virus de la inmunodeficiencia humana (VIH). Si no aparece en la historia clínica no es necesario hacer análisis.
    10. Embarazo o lactancia.
    11. Síndrome de malabsorción u otra patología gastrointestinal que pueda afectar a la absorción oral de AP26113.
    12. Cualquier patología o enfermedad que, en opinión del investigador, pueda comprometer la seguridad del paciente o interferir con la evaluación de seguridad del fármaco.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint for Dose Escalation:
    1. RP2D of orally administered AP26113.

    Expansion Cohorts
    Primary Endpoint:
    1. Overall response rate (using Response Evaluation Criteria in Solid Tumors [RECIST]).
    Componente de aumento escalonado de dosis
    Criterio principal de valoración
    1. DRF2 de AP26113 administrado por vía oral.

    Cohortes de ampliación
    Criterio principal de valoración:
    1. Tasa de respuesta global (utilizando los criterios RECIST de
    evaluación de la respuesta de los tumores sólidos).
    E.5.1.1Timepoint(s) of evaluation of this end point
    RP2D: Not applicable for individual patients
    Overall response rate: throughout course of treatment
    DRF2: no aplica para pacientes a nivel individual.
    Tasa de respuesta global: a lo largo del tratamiento.
    E.5.2Secondary end point(s)
    Secondary Endpoints for Dose Escalation:
    1. MTD of orally administered AP26113.
    2. Safety, tolerability and DLTs of AP26113.
    3. Plasma PK parameters of single-dose and steady state AP26113.

    Secondary Endpoints for Expansion Cohorts:
    1. Safety and tolerability of AP26113.
    2. Plasma PK parameters.
    3. Efficacy assessments include: best target lesion response; progression free survival (PFS); time to progression (TTP); time to treatment failure in patients who remain on study after RECIST progression, but who continue to benefit according to the treating investigator. Overall survival (OS) will also be measured for up to 2 years following the first dose of AP26113.
    Componente de aumento escalonado de dosis
    Criterios secundarios de valoración:
    1. DMT de AP26113 administrado por vía oral.
    2. Seguridad, tolerabilidad y TLD de AP26113.
    3. Parámetros FC en plasma de AP26113 en dosis única y en equilibrio.

    Cohortes de ampliación
    Criterios secundarios de valoración
    1. Seguridad y tolerabilidad de AP26113.
    2. Parámetros FC en plasma.
    3. La evaluación de eficacia: mejor respuesta de la lesión diana; supervivencia sin progresión (SSP); tiempo hasta la progresión (TP); tiempo hasta el fracaso del tratamiento en pacientes que continúan en el estudio tras la progresión
    RECIST, pero que siguen beneficiándose según el investigador responsable del tratamiento. También se medirá la supervivencia global (SG) durante los 2 años siguientes a la primera dosis de AP26113.
    E.5.2.1Timepoint(s) of evaluation of this end point
    MTD: Not applicable for individual patients
    Safety, tolerability and DLTs: throughout course of treatment
    Plasma PK: Cycle 1: Days 1, 2, 8, 15, 22; Cycle 2: Days 1, 2, 3
    Efficacy assessments: throughout course of treatment
    Overall survival: monitored for up to 2 years following first dose AP26113
    DMT: no aplica para pacientes a nivel individual.
    Seguridad, tolerabilidad y TLD: a lo largo del tratamiento.
    FC en plasma: Ciclo 1: Días 1, 2, 8, 15, 22; Ciclo 2: Días 1, 2, 3.
    Evaluaciones de eficacia: a lo largo del tratamiento.
    Supervivencia global: se medirá durante los 2 años siguientes a la primera dosis de AP26113.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    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
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 30
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 130
    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)
    The follow-up period for a patient begins after the last completed assessment during the active study period and continues until patient contact ceases. All patients should be following for survival at least every 3 months (± 14 days), up to 2 years after the initial dose of AP26113.
    El periodo de seguimiento de un paciente comienza después de la última evaluación completada durante el periodo activo del estudio y continúa hasta que finaliza el contacto con el paciente. Se hará un seguimiento de la supervivencia de todos los pacientes, al menos cada 3 meses (±14 días), hasta 2 años después de la dosis inicial de AP26113.
    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 Decision2012-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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