Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39363   clinical trials with a EudraCT protocol, of which   6448   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-003545-18
    Sponsor's Protocol Code Number:C14012
    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:2012-04-17
    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 number2011-003545-18
    A.3Full title of the trial
    A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator?s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
    Ensayo multicéntrico, internacional, de fase 3, de dos grupos, aleatorizado y abierto de alisertib (MLN8237) o la elección del investigador (agente único seleccionado) en pacientes con linfoma de células T periféricas recidivante o resistente al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Trial of Alisertib (MLN8237) or Investigator's Choice (Selected
    Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell
    Lymphoma.
    Un ensayo en Fase III de Alisertib (MLN8237) o a elección del investigador (agente único seleccionado) en pacientes con linfoma de células T periféricas recidivante o resistente al tratamiento.
    A.3.2Name or abbreviated title of the trial where available
    LUMIERE
    LUMIERE
    A.4.1Sponsor's protocol code numberC14012
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01482962
    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 SponsorMillennium 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 supportMillennium Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDrug Information Call Center
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne St
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number001510740-2412
    B.5.5Fax number001800881-6092
    B.5.6E-mailmedical@mlnm.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 nameAlisertib
    D.3.2Product code MLN8237
    D.3.4Pharmaceutical form Film coated gastro-resistant 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 INNAlisertib
    D.3.9.1CAS number 1208255-63-3
    D.3.9.2Current sponsor codeMLN8237
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 RoleComparator
    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.2.1.1.1Trade name FOLOTYN
    D.2.1.1.2Name of the Marketing Authorisation holderAllos Therapeutics, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/444
    D.3 Description of the IMP
    D.3.1Product namePralatrexate
    D.3.4Pharmaceutical form 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 INNpralatrexate
    D.3.9.1CAS number 0146464-95-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 RoleComparator
    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.2.1.1.1Trade name Gemcitabine
    D.2.1.1.2Name of the Marketing Authorisation holderSun Pharmaceutical Industries Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    Relapsed or Refractory Peripheral T-Cell Lymphoma
    linfoma de células T periféricas recidivante o resistente al tratamiento
    E.1.1.1Medical condition in easily understood language
    Relapsed or Refractory Peripheral T-Cell Lymphoma
    linfoma de células T periféricas recidivante o resistente al tratamiento
    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 10034626
    E.1.2Term Peripheral T-cell lymphoma unspecified refractory
    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 10034629
    E.1.2Term Peripheral T-cell lymphoma unspecified stage III
    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 10034627
    E.1.2Term Peripheral T-cell lymphoma unspecified stage I
    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 10034630
    E.1.2Term Peripheral T-cell lymphoma unspecified stage IV
    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 10034623
    E.1.2Term Peripheral T-cell lymphoma unspecified
    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 10034628
    E.1.2Term Peripheral T-cell lymphoma unspecified stage II
    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 10034625
    E.1.2Term Peripheral T-cell lymphoma unspecified recurrent
    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 if alisertib improves overall response rate (ORR; complete response [CR] plus unconfirmed complete response [CRu] plus partial response [PR]) versus a selection of single agents in patients with relapsed or refractory peripheral T-cell
    lymphoma (PTCL)
    - To determine if alisertib improves progression free survival (PFS) versus a selection of single agents in patients with relapsed or refractory PTCL
    -Determinar si alisertib mejora la tasa de respuesta global (TRG: respuesta completa [RC] + respuesta completa no confirmada [RCnc] + respuesta parcial [RP]) frente a una selección de agentes únicos (fármacos en monoterapia) en pacientes con linfoma de células T periféricas (LCTP) recidivante o resistente al tratamiento
    -Determinar si alisertib mejora la supervivencia sin progresión (SSP) frente a una selección de agentes únicos en pacientes con LCTP recidivante o resistente
    E.2.2Secondary objectives of the trial
    Key Secondary:
    - To determine if alisertib improves CR + CRu rate
    - To determine if alisertib improves overall survival (OS)

    Other secondary objectives include:
    - To evaluate the safety and tolerability of alisertib in patients with relapsed or refractory PTCL
    - To measure time to disease progression (TTP)
    - To determine duration of response
    - To measure time to response
    - To measure time to subsequent antineoplastic therapy
    - To collect pharmacokinetic (PK) data to contribute to population PK analyses
    - To evaluate the impact of alisertib treatment versus control on the Quality of Life (QOL) through Functional Assessment of Cancer Therapy ? Lymphoma (FACTLym) for functioning and symptoms
    Objetivos secundarios:
    -Determinar si alisertib mejora la tasa de RC + RCnc
    -Determinar si alisertib mejora la supervivencia global (SG)

    Otros objetivos secundarios adicionales:
    -Evaluar la seguridad y tolerabilidad de alisertib en pacientes con LCTP recidivante o resistente
    -Medir el tiempo transcurrido hasta la progresión de la enfermedad (TTPE)
    -Determinar la duración de la respuesta
    -Medir el tiempo transcurrido hasta la respuesta
    -Medir el tiempo transcurrido hasta la administración del siguiente tratamiento antineoplásico
    -Recopilar datos farmacocinéticos (FC) para contribuir a los análisis FC poblacionales
    -Evaluar el impacto del tratamiento con alisertib frente al control sobre la calidad de vida (CdV) mediante el cuestionario FACT-Lym (evaluación funcional del tratamiento para el cáncer, linfoma) que determina estado funcional y síntomas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients age 18 or older
    - Patients with PTCL according to World Health Organization (WHO) criteria (nodal and extranodal disease subtypes) and have relapsed or are refractory to at least 1 prior systemic, cytoxic therapy for PTCL. Patients must have received conventional therapy as a prior therapy. Cutaneous-only disease is no permitted. Patients must have documented evidence of progressive disease.
    - Tumor biopsy available for central hematopathologic review
    - Measurable disease according to the IWG criteria
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    - Female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse.
    - Male patients who agree to practice effective barrier contraception through 6 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
    - Suitable venous access
    - Voluntary written consent
    -Varones o mujeres mayores de 18 años.
    -Pacientes con diagnóstico de LCTP de acuerdo con los criterios de la OMS, recidivante o resistente como mínimo a un tratamiento citotóxico sistémico previo para el LCTP. Los pacientes deberán haber recibido tratamiento previo con una terapia convencional (no pueden haber recibido tratamiento experimental como el único tratamiento previo). No se permite la enfermedad únicamente cutánea. Los pacientes deberán presentar indicios documentados de progresión de la enfermedad, incluido el diagnóstico patológico local de alguno de los siguientes subtipos:
    ?linfoma de células T periféricas-NOS;
    ?linfoma anaplásico de células grandes (ALK-1 negativo o positivo);
    ?linfoma T angioinmunoblástico;
    ?linfoma de células T asociado a enteropatía;
    ?linfoma hepatoesplénico de células T;
    ?linfoma subcutáneo de células T tipo paniculítico;
    ?micosis fungoide transformada;
    ?linfoma extraganglionar de células NK/T tipo nasal y linfoma nasal de células NK/T;
    ?linfoma NK blástico.
    -Biopsia tumoral disponible para la revisión hematopatológica central:
    -Muestra archivada o biopsia realizada durante la selección en caso de que no se disponga de ninguna muestra obtenida anteriormente (mediante biopsia con aguja gruesa o escisión, pero no mediante aspirado con aguja fina). Tras la inclusión del paciente en el estudio, el diagnóstico histológico realizado por el patólogo local será revisado en el laboratorio central.
    -Enfermedad mensurable de acuerdo con los criterios del IWG (véase la sección 15.4). Los pacientes deberán presentar como mínimo un foco de enfermedad mensurable en 2 dimensiones mediante tomografía computerizada (TC).
    -Estado general de ECOG (Grupo Oncológico Cooperativo del Este) de 0-2.
    -Pacientes mujeres:
    ?En periodo posmenopáusico durante al menos un año antes de la visita de selección, o
    ?Esterilizadas quirúrgicamente, o
    ?En edad fértil, siempre que acepten usar dos métodos anticonceptivos eficaces al mismo tiempo, desde el momento de la firma del documento de consentimiento informado (DCI) hasta 30 días después de la última dosis del tratamiento del estudio, o que acepten abstenerse totalmente de mantener relaciones heterosexuales. Los métodos anticonceptivos hormonales, tales como la píldora anticonceptiva o parches (especialmente los que contienen etinilestradiol) deberán evitarse debido a la posible interacción farmacológica (con romidepsina).
    -Pacientes varones, aunque se hayan esterilizado quirúrgicamente (esto es, estado posterior a la vasectomía), que:
    ?Acepten utilizar un método anticonceptivo de barrera eficaz durante todo el periodo de tratamiento del estudio y hasta 6 meses después de la última dosis del fármaco del estudio [gemcitabina], o
    ?Acepten abstenerse totalmente de mantener relaciones heterosexuales.
    -Acceso venoso adecuado para la realización de extracciones de sangre y administración intravenosa de los tratamientos del estudio, en caso de asignación aleatoria al grupo del comparador.
    -Los pacientes otorgarán su consentimiento informado voluntario por escrito antes de que se realice ninguno de los procedimientos relacionados con el estudio que no formen parte de la atención médica habitual, entendiendo que podrán retirar dicho consentimiento en cualquier momento sin causar perjuicio alguno a su futura atención médica.
    E.4Principal exclusion criteria
    - Known central nervous system lymphoma
    - Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation therapy within 4 weeks of first dose of study treatment or concomitant use during study
    - Prior administration of an Aurora A kinase-targeted agent, including alisertib; or all of the comparator drugs (pralatrexate, gemcitabine; or known hypersensitivity)
    - History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
    - Cardiac condition as specified in study protocol, including left ventricular ejection fraction (LVEF) <40%
    - Concomitant use of other medicines as specified in study protocol
    - Patients with abnormal gastric or bowel function who require continuous treatment with H2-receptor antagonists or proton pump inhibitors
    - Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C
    - Autologous stem cell transplant less than 3 months prior to enrollment
    - Patients who have undergone allogeneic stem cell or organ transplantation any time
    - Inadequate blood levels, bone marrow or other organ function as specified in study protocol
    - The patient must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ? 1 toxicity, to patients's baseline status (except alopecia), or deemed irreversible from the effects of prior cancer therapy
    - Major surgery, serious infection, or infection requiring systemic antibiotic therapy within 14 days prior to the first dose of study treatment
    - Female patients who are breastfeeding or pregnant
    - Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years
    - Serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
    -Linfoma del sistema nervioso central documentado
    -Tratamiento antineoplásico sistémico, inmunoterapia, fármaco en investigación o radioterapia administrados durante las 4 semanas anteriores a la primera dosis de tratamiento del estudio o uso concomitante de alguno de los mismos durante el estudio.
    -Administración previa de un agente dirigido a la quinasa Aurora A, incluyendo alisertib o todos los fármacos de comparación (pralatrexato, romidepsina y gemcitabina).
    -Antecedentes de síndrome de apnea del sueño no controlado u otros trastornos que pudieran producir somnolencia diurna excesiva.
    -Afección cardiaca como se especifica en el protocolo del estudio, incluyendo la fracción de eyección ventricular izquierda (FEVI) < 40% mediante estudio de ventriculografía isotópica o ecocardiograma.
    -Uso concomitante de otros medicamentos como se especifica en el protocolo del estudio.
    -Pacientes con función gástrica o intestinal anómala que requieran tratamiento continuo con antagonistas del receptor H2 o inhibidores de la bomba de protones.
    -Infección activa documentada por el virus de la inmunodeficiencia humana (VIH), hepatitis B o hepatitis C.
    -Autotrasplante de células madre durante los 3 meses anteriores a la primera dosis de tratamiento del estudio.
    -Alotrasplante de células madre o trasplante de órgano sólido en cualquier momento.
    -Niveles inadecuados en la sangre, la médula ósea, o la función de otros órganos como se especifica en el protocolo del estudio.
    -El paciente deberá haberse recuperado a un grado de toxicidad < 1 según los NCI CTCAE (Criterios Terminológicos Comunes para Acontecimientos Adversos del Instituto Nacional del Cáncer), a su estado inicial (a excepción de la alopecia) o se considera irreversible debido a los efectos del tratamiento antineoplásico anterior.
    -Cirugía Mayor, infección activa clínicamente significativa o infección que requiera tratamiento sistémico con antibióticos durante los 14 días anteriores a la primera dosis de tratamiento del estudio.
    -Mujeres en período de lactancia o que presenten una prueba de embarazo en suero positiva.
    -Segunda neoplasia maligna coexistente o antecedentes de neoplasia maligna previa de órgano sólido durante los 3 últimos años.
    -Cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico o anomalía analítica que pudiera aumentar el riesgo asociado a la participación en el ensayo clínico o a la administración del producto en investigación, o que pudiera interferir en la interpretación de los resultados del ensayo clínico y, que a juicio del investigador, pudiera hacer que la inclusión del paciente en el presente ensayo se considerara inapropiada.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are:
    - ORR: CR + CRu + PR based on independent radiology committee (IRC) assessment using the IWG criteria
    - PFS based on IRC assessment using the IWG criteria
    Los criterios principales de valoración son:
    -TRG: RC + RCnc + RP basada en la evaluación de un comité de radiología independiente (CRI) que utilizará los criterios del IWG
    -SSP basada en la evaluación del CRI que utilizará los criterios del IWG
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint for evaluation for all endpoints is anticipated to occur in May2017
    Se prevee que la fecha exacta para la evaluación de las variables de valoración sea Mayo de 2017.
    E.5.2Secondary end point(s)
    The key secondary endpoints are:
    - CR + CRu rate
    - Overall survival

    Other secondary endpoints include:
    - Adverse events (AEs), serious adverse events (SAEs), assessments of clinical laboratory values and clinically important laboratory abnormalities, and vital sign measurements
    - Time to disease progression
    - Duration of response
    - Time to response
    - Time to subsequent antineoplastic therapy
    - Plasma concentration-time data to contribute to future population PK analysis
    - Changes in reported symptoms and QOL assessment per FACT-Lym for functioning and symptoms
    Los criterios secundarios clave de valoración son:
    -Tasa de RC + RCnc
    -Supervivencia global

    Otros criterios secundarios de valoración son:
    -Acontecimientos adversos (AA), acontecimientos adversos graves (AAG), evaluaciones de los valores analíticos y de las anomalías analíticas clínicamente relevantes , así como determinación de las constantes vitales
    -Tiempo transcurrido hasta la progresión de la enfermedad
    -Duración de la respuesta
    -Tiempo transcurrido hasta la respuesta
    -Tiempo transcurrido hasta la administración del siguiente tratamiento antineoplásico
    -Datos de la curva de concentración plasmática frente a tiempo para contribuir a futuros análisis FC poblacionales
    -Cambios en los síntomas referidos y evaluación de la CdV mediante el cuestionario FACT-Lym para determinar el estado funcional y los síntomas de los pacientes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint for evaluation for all endpoints is anticipated to occur in May2017
    Se prevee que la fecha exacta para la evaluación de las variables de valoración sea Mayo de 2017.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    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
    Brazil
    Canada
    Chile
    Egypt
    Israel
    Mexico
    New Zealand
    Peru
    Russian Federation
    Turkey
    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
    last patient last visit
    última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 226
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 354
    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)
    not applicable
    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 Decision2012-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-18
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA