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    Summary
    EudraCT Number:2015-005069-21
    Sponsor's Protocol Code Number:I4D-MC-JTJH
    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:2016-04-20
    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 number2015-005069-21
    A.3Full title of the trial
    A Phase 2 Study of LY2606368 in Patients with Extensive Stage Disease Small Cell Lung Cancer
    Estudio en fase 2 de LY2606368 en pacientes con cáncer de pulmón microcítico en estadio avanzado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial in Patients with Extensive Small Cell Lung Cancer
    Ensayo clínico en pacientes con cáncer de pulmón microcítico en estadio avanzado
    A.4.1Sponsor's protocol code numberI4D-MC-JTJH
    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 SponsorLilly 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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly S.A.
    B.5.2Functional name of contact pointElena Tsiamparlis
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de la Industria 30
    B.5.3.2Town/ cityAlcobendas-Madrid
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number34916231551
    B.5.5Fax number34916633481
    B.5.6E-mailensayosclinicos@lilly.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 nameLY2606368
    D.3.2Product code LY2606368
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNNot available
    D.3.9.1CAS number 1234015-57-6
    D.3.9.2Current sponsor codeLY2606368
    D.3.9.3Other descriptive nameLY2606368
    D.3.9.4EV Substance CodeSUB176839
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    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
    Extensive Disease Small Cell Lung Cancer
    Cáncer de pulmón microcítico en estadio avanzado
    E.1.1.1Medical condition in easily understood language
    Extensive Disease Small Cell Lung Cancer
    Cáncer de pulmón microcítico en estadio avanzado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10041068
    E.1.2Term Small cell lung cancer extensive stage
    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
    Cohort 1: To estimate the Overall Response Rate (ORR) when a dose of 105 mg/m2 LY2606368 every 14 days is administered to patients with ED-SCLC that have platinum-sensitive disease.

    Cohort 2: To estimate the ORR when a dose of 105 mg/m2 LY2606368 every 14 days is administered in patients with Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) that have platinum resistant/refractory disease.
    Cohorte 1: Estimar la TGR cuando se administra una dosis de 105 mg/m2 de LY2606368 cada 14 días a pacientes con CPM-EA que presenten enfermedad sensible al platino.
    Cohorte 2: Estimar la TGR cuando se administra una dosis de 105 mg/m2 de LY2606368 cada 14 días a pacientes con CPM-EA que presenten resistencia primaria o secundaria al platino.
    E.2.2Secondary objectives of the trial
    -To characterize the safety and toxicity profile of LY2606368
    -To characterize the pharmacokinetics (PK) of LY2606368
    -To estimate secondary efficacy measures including disease control rate (DCR), duration of response (DoR), progression free survival (PFS), and overall survival (OS)
    - To evaluate the association between best tumor response and change from baseline in lung cancer-specific symptoms, symptomatic distress, activity status, overall quality of life, total Lung Cancer Symptom Scale (LCSS) score and Average Symptom Burden Index (ABSI) for patients who have platinum-sensitive or platinum-resistant/refractory SCLC
    -Caracterizar el perfil de seguridad y toxicidad de LY2606368.
    -Caracterizar la FC de LY2606368
    -Calcular los criterios secundarios de valoración de la eficacia, entre otros, la tasa de control de la enfermedad (TCE), la duración de la respuesta (DdR), la supervivencia sin progresión (SSP) y la supervivencia global (SG)
    -Evaluar la relación entre la mejor respuesta tumoral y la variación respecto al período basal de los síntomas específicos del cáncer de pulmón, las molestias sintomáticas, el grado de actividad, la calidad de vida global, la puntuación total en la escala de síntomas del cáncer de pulmón (LCSS) y en el índice de la carga sintomática media (ASBI) en pacientes con CPM sensible al platino o que presente resistencia primara/secundaria al platino
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Have histological or cytological diagnosis of ED-SCLC and received a prior platinum-based regimen. Cohort 1 must have had an objective response to prior platinum-based therapy with subsequent progression >= 90 days after the last dose of platinum. Cohort 2 must either have had an objective response to prior platinum based therapy or had progression < 90 days after the last dose of platinum
    -Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
    -Have at least 1 measurable lesion using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    -Have adequate organ function, including:
    Hematologic: Absolute Neutrophil Count (ANC) >= 1.5x 10^9/L, platelets >= 100 x 10^9/L, Hemoglobin >= 8 g/dL or >=5 mmol
    Hepatic: direct bilirubin <= 1.5 x ULN, ALT and AST <= 2.5 x ULN or <= 5 x ULN (if the liver has involvement)
    Renal: Serum creatinine, or measured creatinine clearance, or calculated creatine clearance (using the Chronic Kidney Disease Epidemiology Collaboration (CKP-EPI) equation) < 1.5 x ULN or >= 50 mL/min/1.73 m^2
    -Men must be sterile or agree to use an effective method of birth control during the study and for at least 12 weeks following the last dose of LY2606368
    -Women must have a negative serum pregnancy test at screening, have another negative urine pregnancy test within 7 days prior to the first dose of LY2606368, and agree to use a highly effective method of birth control during the study and for 12 weeks following the last dose of LY2606368. Women on study must also not breastfeed.
    -Presentar diagnóstico histológico o citológico de CPM-EA y haber recibido un tratamiento anterior basado en platino. Cohorte 1: haber alcanzado una respuesta objetiva con un tratamiento anterior basado en platino y posteriormente haber experimentado progresión de la enfermedad, ? 90 días después de la última dosis de platino.
    Cohorte 2: no haber alcanzado una respuesta objetiva con un tratamiento anterior basado en platino o haber experimentado progresión de la enfermedad < 90 días después de la última dosis de platino
    -Presentar una categoría funcional de 0 o 1 en la Escala ECOG.
    -Presentar al menos 1 lesión mensurable, de acuerdo con las técnicas habituales y los Criterios RECIST 1.1.
    -Tener una función orgánica aceptable, de acuerdo con los siguientes parámetros:
    Hematologicos: Recuento absoluto neutrófilos >= 1,5 × 10^9/l; Plaquetas >= 100 × 10^9/l; Hemoglobina >= 8 g/dl o >= 5 mmol.
    Hepaticos: Bilirrubina directa <=1,5 × LSN; ALT y AST <= 2,5 × LSN o <= 5 × LSN si el hígado presenta afectación tumoral.
    Renal: Creatinina sérica O Aclaramiento de creatinina medido O Aclaramiento de creatinina calculado (utilizando la ecuación CKP-EPI < 1,5 × LSN O >= 50 ml/min/1,73 m2.
    -Los varones deben ser estériles o estar de acuerdo en utilizar un método anticonceptivo eficaz o muy eficaz, tanto durante el estudio como al menos durante las 12 semanas posteriores a la última dosis de LY2606368.
    -Las mujeres deben presentar una prueba de embarazo negativa en suero en la visita basal, un resultado negativo en una prueba de embarazo en orina en los 7 días anteriores a la primera dosis de LY2606368, y estar de acuerdo en utilizar un método anticonceptivo muy eficaz durante el estudio y durante las 12 semanas posteriores a la última dosis de LY2606368. Además no deben estar en período de lactancia.
    E.4Principal exclusion criteria
    -Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
    -Have symptomatic central nervous system (CNS) malignancy or metastasis.
    -Have a second primary malignancy that may affect the results of the study (investigator and study sponsor discretion)
    -Have previously completed or withdrawn from this study or any other study investigating LY2606368 or a CHK 1 Inhibitor
    -Have serious pre-existing medical conditions (left to the discretion of the investigator)
    -Have a serious cardiac condition
    -Have QTc interval of > 470 msec on more than one screening ECG
    -Have a family history of long QT-syndrome
    -Have symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C
    -Haber recibido más de 2 tratamientos anteriores para el CPM-EA (incluidos inmunoterapia, tratamientos dirigidos o quimioterapia).
    -Presencia de neoplasias malignas o metástasis sintomáticas en el sistema nervioso central (SNC). Los pacientes asintomáticos con metástasis tratadas en el SNC deben permanecer estables mediante evaluación clínica durante al menos 14 días, y los pacientes no deben haber recibido corticosteroides para tratar las metástasis en el SNC en los 14 días previos a la primera dosis con el fármaco del estudio.
    -Presentar una segunda neoplasia maligna primaria que, de acuerdo con el criterio del investigador y de Lilly, pueda interferir en la interpretación de los resultados.
    -Haber completado o haber sido retirado de este o de cualquier otro estudio en el que se investigue LY2606368 o cualquier otro inhibidor de la CHK1 o haber mostrado hipersensibilidad a cualquiera de los componentes de LY2606368.
    -Tener trastornos graves preexistentes, a criterio del investigador.
    -Padecer una cardiopatía grave.
    -Intervalo QTc > 470 ms, en más de un electrocardiograma (ECG) realizado durante la selección.
    -Antecedentes familiares de síndrome del QT largo.
    -Presentar infección sintomática por el virus de la inmunodeficiencia humana (VIH) o infección activada/reactivada y sintomática por el virus de la hepatitis A, B o C (no se requieren pruebas de cribado). Si la historia médica, síntomas y/o valores de laboratorio sugieren que el paciente tenga VIH o hepatitis A, B o C, se deberá llevar a cabo la evaluación apropiada para determinar si el paciente debería ser excluido..
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response as determined by RECIST 1.1
    Mejor respuesta global, de acuerdo con los criterios RECIST versión 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease assessment starting at 6 weeks and continuing every 6 weeks until disease progression or participant discontinuation (estimated 14 weeks)
    Evaluacion de la enfermedad a las 6 semanas y continuando cada 6 semanas hasta progression de la enfermedad o discontinuación del participante (estimado 14 semanas)
    E.5.2Secondary end point(s)
    -AEs and laboratory measurements
    -PK profile of LY2606368: maximum concentration (Cmax) and time of maximal concentration (tmax)
    -Disease control rate
    -Duration or response
    -Progression free survival
    -Overall survival
    -Lung cancer symptoms and global quality of life
    -AAs y medidas de laboratorio
    -Perfil FC de LY 2606368: Cmax y Tmax
    -Tasa de control de la enfermedad
    -Duración de la respuesta
    -Supervivencia libre de progresión
    -Supervivencia global
    -Sintomas de Cancer de pulmón y calidad de vida global
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Weekly during treatment and 30 days after treatment (estimated 18 weeks)
    -Cmax and tmax: either post dose and/or predose LY2606368 (estimated 14 weeks)
    -Best overall response: radiologic assessment starting at 6 weeks and continuing every 6 weeks until disease progression (estimated at 14 weeks)
    -Time from an objective response assessment until disease progression or death from any cause in absence of progressive disease (estimated at 14 weeks)
    -Time from enrollment until the first radiographic documentation of progressive disease or death from any cause in absence on progressive disease (estimated at 18 weeks)
    -Time from enrollment until death from any cause (estimated at 15 months)
    -Lung cancer symptoms, total LCSS and ASBI (estimated at 42 weeks)
    -Semanalmente durante tratamiento y 30 dias despues (estimado 18 semanas)
    -Cmax y Tmax: post-dosis y/o predosis de LY2606368 (estimado 14 semanas)
    -Mejor respuesta global: Evaluacion radiológica a 6 semanas y continuando cada 6 semanas hasta progression o discontinuación del participante (estimado 14 semanas)
    -Tiempo desde evaluación de respuesta objetiva hasta progresión o fallecimiento por cualquier causa en ausencia de progresión (estimado 14 semanas)
    -Tiempo desde inclusion hasta primera documentación radiográfica de progresion o fallecimiento por cualquier causa en ausencia de progresión (estimado 18 semanas)
    -Tiempo desde inclusión hasta fallecimiento por cualquier causa (estimado a los 15 meses)
    -Sintomas cáncer pulmón, LCSS total y ASBI (estimado 42 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 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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health outcomes
    Resultados de la salud
    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.8.2.4Number 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    France
    Germany
    Greece
    Korea, Republic of
    Netherlands
    Spain
    Turkey
    Ukraine
    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
    LVLS
    Ultima visita Ultimo paciente
    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 months4
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days15
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 68
    F.4.2.2In the whole clinical trial 116
    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)
    Patient will be monitored for safety 30 days after the last day of treatment. Patient will be followed for survival approximately every 60 days following their initial 30 day discontinuation follow-up visit until the patient dies or is lost to follow-up.
    Se monitorizara la seguridad del paciente 30 dias tras el ultimo dia de tratamiento. Le realizara un seguimiento de supervivencia aproximadamente cada 60 dias tras la visita de seguimiento inicial de los 30 dias hasta que el paciente fallezca o se pierda el contacto.
    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 Decision2016-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-20
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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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