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    Summary
    EudraCT Number:2012-003474-36
    Sponsor's Protocol Code Number:CLDK378A2203
    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:2012-10-29
    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 number2012-003474-36
    A.3Full title of the trial
    A phase II, multicenter, single-arm study of oral LDK378 in crizotinib naïve adult patients with ALK-activated non-small cell lung cancer
    Estudio de fase II, multicéntrico, de un solo brazo de LDK378 oral en pacientes adultos con cáncer de pulmón de células no pequeñas con ALK-activado que no han recibido crizotinib anteriormente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study of oral LDK378 in adult patients with ALK-activated non-small cell lung cancer and who have not been previously treated with crizotinib
    Ensayo clínico LDK378 oral en pacientes con cáncer de pulmón de células no pequeñas con reordenamiento de ALK que no han recibido crizotinib anteriormente
    A.4.1Sponsor's protocol code numberCLDK378A2203
    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 Farmaceútica, 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 Farmaceútica, 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 number003493 306 44 64
    B.5.5Fax number003493 306 42 90
    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.3.2Product code LDK378
    D.3.4Pharmaceutical form Capsule
    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 INNLDK378
    D.3.9.2Current sponsor codeLDK378
    D.3.9.3Other descriptive nameLDK378
    D.3.9.4EV Substance CodeSUB31640
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 LDK378
    D.3.4Pharmaceutical form Capsule
    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 INNLDK378
    D.3.9.2Current sponsor codeLDK378
    D.3.9.3Other descriptive nameLDK378
    D.3.9.4EV Substance CodeSUB31640
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 3
    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 LDK378
    D.3.4Pharmaceutical form Capsule
    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 INNLDK378
    D.3.9.2Current sponsor codeLDK378
    D.3.9.3Other descriptive nameLDK378
    D.3.9.4EV Substance CodeSUB31640
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Non-small cell lung cancer
    Cáncer de pulmón de células no pequeñas
    E.1.1.1Medical condition in easily understood language
    Non-small cell lung cancer
    cáncer de pulmón de células no pequeñas
    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 PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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
    To demonstrate the antitumor activity of LDK378, as measured by overall response rate (ORR) to LDK378 by investigator assessment
    Demostrar la actividad antitumoral de LDK378, determinada mediante la tasa de respuesta global (TRG) a LDK378 evaluada por el investigador
    E.2.2Secondary objectives of the trial
    To evaluate response related endpoints as assessed by investigator and Blinded Independent Review Committee (BIRC):
    - Duration of response (DOR)
    - Disease control rate (DCR)
    - Time to response (TTR)
    To assess ORR by BIRC assessment
    To evaluate the safety profile of LDK378
    To evaluate progression-free survival (PFS)
    To evaluate overall survival (OS)
    Evaluar las variables de respuesta relacionadas evaluadas por el investigador y el Comité de Revisión Independiente Ciego (CRIC):
    Duración de respuesta (DOR)
    Tasa de control de la enfermedad (DCR)
    Tiempo hasta la respuesta (TTR)
    Evaluar TRG mediante evaluación del CRIC
    Evaluar el perfil de seguridad de LDK378
    Evaluar la supervivencia sin progresión (PFS)
    Evaluar la supervivencia global (SG)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC that carries an ALK rearrangement defined as 15% or more positive tumor cells as assessed by the FDA-approved FISH test (Abbott Molecular Inc)
    2. Age 18 years or older at the time of informed consent.
    3. Patients must have NSCLC that has progressed during therapy.
    4. Patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic NSCLC
    5. Patients must have archival tissue, collected either at the time of diagnosis of NSCLC or any time since.
    6. Patients must have recovered from all toxicities related to prior anticancer therapies to grade ? 2 except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study

    Other protocol defined inclusion criteria may apply
    1. Diagnóstico confirmado histológicamente o citológicamente de NSCLC localmente avanzado o metastásico que lleva reordenamiento de ALK, confirmado con el ensayo FISH aprobado por la FDA (Abbott Molecular Inc.).
    2. Edad de 18 años o superior en el momento del consentimiento informado.
    3. Pacientes con NSCLC que han progresado durante el tratamiento
    4. Los pacientes deben haber recibido 1-3 líneas de quimioterapia citotóxica (de las cuales 1 debe haber sido un doblete de platino) para tratar su NSCLC localmente avanzado o metastásico.
    5. Los pacientes deben disponer de muestra de tejido guardada, obtenida en el momento del diagnóstico de NSCLC o en cualquier momento desde entonces.
    6. Los pacientes deben haberse recuperado de todas las toxicidades relacionadas con terapias anticáncer previas a grado ? 2, excepto para los pacientes con náuseas/vómitos de grado 2 y/o diarrea de grado 2 a pesar de recibir terapia de apoyo óptima a quienes no se permitirá participar en el estudio.

    Otros criterios de exclusión aplican por protocolo
    E.4Principal exclusion criteria
    1. Prior treatment with crizotinib, or any other ALK inhibitor investigational agent, for NSCLC
    2. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
    3. History of carcinomatous meningitis.
    4. Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
    5. Clinically significant, uncontrolled heart disease

    Other protocol defined exclusion criteria may apply
    1. Tratamiento previo con crizotinib, o cualquier otro agente en investigación inhibidor de ALK, para NSCLC.
    2. Pacientes con metástasis del sistema nervioso central (SNC) que sean neurológicamente inestables o hayan precisado aumento de la dosis de esteroides en las 2 semanas previas a la inclusión en el estudio para controlar los síntomas del SNC.
    3. Antecedentes de meningitis carcinomatosa.
    4. Presencia o antecedentes de otra enfermedad maligna distinta a NSCLC que ha sido diagnosticada y/o precisó terapia en los últimos 3 años. Excepciones a esta exclusión incluye lo siguiente: cánceres de piel de células basales y de células escamosas completamente resecados, y carcinoma in situ completamente resecado de cualquier tipo.
    5. Alteración cardiaca no controlada, clínicamente significativa
    Otros criterios de exclusión aplican por protocolo
    E.5 End points
    E.5.1Primary end point(s)
    ORR per RECIST v1.1 calculated as the proportion of patients with a best overall response defined as complete response or partial response (CR+PR) as assessed by investigator
    TRG según RECIST v1.1 calculada como la proporción de pacientes con una mayor respuesta global definida como respuesta completa o respuesta parcial (RC+RP) evaluado por el investigador
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 cycles of 28 days
    6 ciclos de 28 dias
    E.5.2Secondary end point(s)
    - DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by investigator and BIRC assessment
    - DCR, calculated as the proportion of patients with best overall response of CR, PR, or SD, by investigator and BIRC assessment
    - TTR, calculated as the time from first dose of LDK378 to first documented response (CR+PR), by investigator and BIRC assessment
    - ORR (CR+PR) per RECIST v1.1 as assessed by BIRC
    - Adverse events and laboratory abnormalities
    - PFS, defined as time from first dose of LDK378 to progression or death due to any cause, as assessed by BIRC and investigator assessment
    - OS, defined as time from first dose of LDK378 to death due to any cause
    -DOR, calculado como el tiempo desde la fecha de la primera RC o RP documentada hasta la primera progresión o muerte documentada debido a cáncer subyacente
    -DCR, calculado como la proporción de pacientes con la mejor respuesta global de RC, RP, o EE
    -TTR, calculado como el tiempo desde la primera dosis de LDK378 hasta la primera respuesta documentada (RC+ RP)
    -TRG (RC+RP) según RECIST v1.1 evaluada por CRIC
    -Acontecimientos adversos y anomalías analíticas
    -PFS, definida como tiempo desde la primera dosis de LDK378 hasta progresión o muerte debido a cualquier causa, evaluado por CRIC y por el investigador
    -SG, definida como el tiempo desde la primera dosis de LDK378 a muerte debido a cualquier causa
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 cycles of 28 days for all
    6 ciclos de 20 dias para todos
    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 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Australia
    Belgium
    Canada
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Democratic People's Republic of
    Norway
    Singapore
    Spain
    Sweden
    Taiwan
    Thailand
    United Kingdom
    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 study will end once at least 75% of patients have died. Patients continuing to derive benefit from the study treatment at the end of the study in the opinion of the investigator will be able to continue receiving LDK378 on a separate protocol
    El estudio finalizará una vez que al menos el 75% de los pacientes hayan muerto. Los pacientes que continuen beneficiandose del tratamiento del estudio al final del estudio, a opinión del investigador será posible continuar recibiendo LDK378 en un protocolo separado
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 105
    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)
    After discontinuing LDK378, further treatment for NSCLC is left to the physician's discretion
    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 Decision2012-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-22
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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