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    Summary
    EudraCT Number:2012-000677-23
    Sponsor's Protocol Code Number:CLCL161A2201
    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:2012-06-22
    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 number2012-000677-23
    A.3Full title of the trial
    A Phase II, multi-center, open-label, neoadjuvant, randomized study of
    weekly paclitaxel with or without LCL161 in patients with triple negative
    breast cancer
    Estudio de Fase II, multicéntrico, abierto, aleatorizado, tratamiento neoadyuvante con paclitaxel semanal con o sin LCL161 en pacientes con cáncer de mama triple negativo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, multi-center, open-label, neoadjuvant, randomized study of
    weekly paclitaxel with or without LCL161 in patients with triple negative
    breast cancer
    Estudio de Fase II, multicéntrico, abierto, aleatorizado, tratamiento neoadyuvante con paclitaxel semanal con o sin LCL161 en pacientes con cáncer de mama triple negativo
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCLCL161A2201
    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 SponsorNovartis farmacéutica S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A
    B.5.2Functional name of contact pointJavier Malpesa
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number003493306 44 64
    B.5.5Fax number00349393 306 46 15
    B.5.6E-maileecc.novartis@novartis.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 nameLCL161
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeLCL161
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.IMP: 2
    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 Yes
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression
    mujeres con cáncer de mama triple negativo que tengan el perfil de expresión génica específica
    E.1.1.1Medical condition in easily understood language
    Women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression
    mujeres con cáncer de mama triple negativo que tengan el perfil de expresión génica específica
    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 whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer that are positive for the gene expression signature.
    Evaluar si la adición de LCL161 a paclitaxel semanal aumenta la eficacia de paclitaxel en mujeres con cáncer de mama triple negativo que tengan el perfil de expresión génica específica
    E.2.2Secondary objectives of the trial
    1. To characterize the safety and tolerability of the LCL161/paclitaxel combination compared to weekly paclitaxel alone.
    2. To assess other indicators of disease response for the LCL161 + Paclitaxel combination compared to paclitaxel alone.
    3. To evaluate whether combination treatment with LCL161 and
    paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone.
    4. To evaluate the PK of LCL161 when given in combination with
    paclitaxel.
    1. Caracterizar la seguridad y tolerabilidad de la combinación de LCL161/paclitaxel en comparación con paclitaxel semanal en monoterapia
    2. Evaluar otros indicadores de respuesta a la enfermedad para la combinación de LCL161 + paclitaxel en comparación con paclitaxel en monoterapia
    3. Evaluar si el tratamiento combinado con LCL161 y paclitaxel está asociado a un aumento de la apoptosis en comparación con paclitaxel semanal en monoterapia
    4. Evaluar la PK de LCL161 cuando se administra en combinación con paclitaxel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed diagnosis of invasive triple negative breast cancer.
    - Tumor must be positive for the LCL161 predictive gene expression profile as determined during molecular pre-screening.
    - Candidates for mastectomy or breast-conserving surgery.
    - Primary tumor of greater than 20 mm and less than 50 mm diameter measured by imaging.
    - Absence of distant metastatic disease.
    - ECOG performance status 0-1.
    - Adequate bone marrow function.
    - Adequate liver function and serum transaminases.
    - Adequate renal function.
    1. Diagnóstico histológicamente confirmado de cáncer de mama triple negativo invasivo
    2. Positivo para el perfil de expresión génica predictivo de LCL161, determinado durante la preselección molecular
    3. Candidatas a mastectomía o cirugía conservadora de la mama
    4. Tumor primario de más de 20 mm y menos de 50 mm de diámetro, medido mediante técnicas de diagnóstico por la imagen
    5. Ausencia de enfermedad metastásica distante
    6. Estado funcional ECOG 0-1
    7. Función adecuada de la médula ósea
    8. Función hepática adecuada y transaminasas en suero normales
    9. Función renal adecuada
    E.4Principal exclusion criteria
    - Multicentric invasive tumors; bilateral or inflammatory breast cancer, locally recurrent breast cancer.
    - Patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months.
    - Uncontrolled cardiac disease.
    - Patients who are currently receiving chronic treatment with
    corticosteroids at a dose ? 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug.
    - Impaired GI function that may affect the absorption of LCL161.
    - Pregnant or breast feeding (lactating) women.
    - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 90 days after study treatment.
    - Other protocol-defined inclusion/exclusion criteria may apply.
    1. Tumores invasivos multicéntricos , cáncer de mama bilateral o inflamatorio , cáncer de mama localmente recurrente
    2. Las pacientes que actualmente estén recibiendo terapia sistémica para cualquier otra enfermedad maligna, o que hayan recibido terapia sistémica para una enfermedad maligna en los 3 meses anteriores
    3. Cardiopatía no controlada
    4. Pacientes que actualmente estén recibiendo tratamiento crónico con corticoesteroides a una dosis ? 10 mg de prednisona (o su equivalente glucocorticoide) al día (se permiten esteroides inhalados y tópicos), o cualquier otro tratamiento inmunosupresor crónico que no pueda interrumpirse antes de iniciar la medicación del estudio.
    5. Alteración de la función GI que puede afectar la absorción de LCL161
    6. Mujeres embarazadas o en período de lactancia
    7. Mujeres en edad fértil, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, salvo que estén utilizando métodos anticonceptivos altamente eficaces durante la administración y durante los 90 días posteriores al tratamiento del estudio.
    8. Otros criterios de inclusión/exclusión del protocolo serán aplicables
    E.5 End points
    E.5.1Primary end point(s)
    - Pathological complete response (pCR) rate in breast after 12 weeks of therapy in the control and experimental arms
    Tasa de respuesta patológica completa (RPc) en mama tras 12 semanas de terapia en los brazos control y experimental
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    1. Frequency of adverse events, serious adverse events and clinical
    laboratory abnormalities
    2.
    - pCR rate in breast, regional nodes and axilla
    - rates of breast conserving surgery and mastectomy
    - clinical response
    - disease response using RECIST 1.1 criteria
    3. Caspase 3 activation in tumor by IHC
    4. PK parameters including but not limited to Cmax, Tmax, and AUC last
    1. Frecuencia de acontecimientos adversos, acontecimientos adversos graves y anormalidades clínicas de laboratorio
    2.
    - tasa de RPc en mama, ganglios linfáticos regionales y axila
    - Tasas de cirugía de conservación de mama y mastectomía
    - Respuesta clínica
    - Respuesta a la enfermedad empleando criterios RECIST 1.1
    3. Activación de caspasa 3 en tumor mediante IHC
    4. Parámetros PK que incluyen pero no se limitan a Cmax, Tmax y AUClast
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 16 weeks
    2. 12 weeks
    3. 12 weeks
    4. 12 weeks
    1. 16 semanas
    2. 12 semanas
    3. 12 semanas
    4. 12 semanas
    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 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 Yes
    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) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Argentina
    Australia
    Belgium
    Czech Republic
    France
    Ireland
    Italy
    Korea, Republic of
    Spain
    Taiwan
    Turkey
    United Kingdom
    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 the study for each patient will occur approximately 30 days after the last administration of study medication (LCL161 or
    paclitaxel), and the study will be completed after the end of study
    assessment has been performed for the last patient treated.
    El final del estudio para cada paciente se producirá aproximadamente 30 días después de la última administración de la medicación del estudio (LCL161 o paclitaxel), y el estudio se completará después de que las evaluaciones del final del estudio se hayan realizado para el último paciente tratado.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 100
    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 completion of study treatment, patients are expected to continue post-operative treatment with a standard anthracycline-based chemotherapy regimen such as FAC (5-FU/doxorubicin/cyclophosphamide), FEC (5-FU/epirubicin/cyclophosphamide) or AC (doxorubicin/cyclophosphamide). The specific regimen will be chosen by the treating physician.
    A la finalización del tratamiento del estudio, los pacientes se espera que continúen el tratamiento postoperatorio con un régimen de quimioterapia estándar basada en antraciclinas como FAC (5-FU/doxorubicin/cyclophosphamide), FEC (5-FU/epirubicin/cyclophosphamide) o AC (doxorubicina / ciclofosfamida). El régimen específico será elegido por el médico.
    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 Decision2012-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
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