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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

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    Summary
    EudraCT Number:2016-001352-21
    Sponsor's Protocol Code Number:ABT-C5-2016
    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:2016-07-15
    Trial 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 number2016-001352-21
    A.3Full title of the trial
    A phase I/ II, open label study to assess the efficacy and safety of ABTL0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous NSCLC
    Estudio abierto fase I/II para evaluar la eficacia y seguridad de ABTL0812 en combinación con paclitaxel y carboplatino en pacientes con cáncer de endometrio avanzado o cáncer de pulmón escamoso
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase I/ II study to assess the efficacy and safety of ABTL0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous NSCLC
    Estudio fase I/II para evaluar la eficacia y seguridad de ABTL0812 en combinación con paclitaxel y carboplatino en pacientes con cáncer de endometrio avanzado o cáncer de pulmón escamoso
    A.4.1Sponsor's protocol code numberABT-C5-2016
    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 SponsorAbility Pharmaceuticals, SL
    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 supportAbility Pharmaceuticals, SL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRecerca Clinica
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressLlull 393
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number34933005218
    B.5.5Fax number0034934851401
    B.5.6E-mailsoler.y@recercaclinica.es
    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 nameABTL0812
    D.3.2Product code ABTL0812
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNABTL0812
    D.3.9.2Current sponsor codeABTL0812
    D.3.9.3Other descriptive nameABTL0812
    D.3.9.4EV Substance CodeSUB119959
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1500 to 3900
    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
    Squamous Cell Non-Small Cell Lung Cancer
    and
    advanced endometrial cancer
    Cáncer de pulmón escamoso
    y
    cáncer de endometrio avanzado
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    and
    endometrial cancer
    Cáncer de pulmón
    y
    cáncer de endometrio
    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 LLT
    E.1.2Classification code 10014743
    E.1.2Term Endometrial carcinoma
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10025120
    E.1.2Term Lung squamous cell carcinoma recurrent
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10071533
    E.1.2Term Lung squamous cell carcinoma metastatic
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10014747
    E.1.2Term Endometrial carcinoma recurrent
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10025124
    E.1.2Term Lung squamous cell carcinoma 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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10014745
    E.1.2Term Endometrial carcinoma metastatic
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10014749
    E.1.2Term Endometrial carcinoma 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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10014751
    E.1.2Term Endometrial carcinoma 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 19.0
    E.1.2Level PT
    E.1.2Classification code 10025125
    E.1.2Term Lung squamous cell carcinoma 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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10014750
    E.1.2Term Endometrial carcinoma 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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10025126
    E.1.2Term Lung squamous cell carcinoma stage unspecified
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess safety and tolerability of ABTL0812 plus paclitaxel + carboplatin in patients with advanced or metastatic endometrial cancer or squamous NSCLC at first line therapy
    Evaluar la seguridad y tolerabilidad de ABTL0812 en combinación con paclitaxel + carboplatino en pacientes con cáncer avanzado de endometrio o cáncer escamoso de pulmón
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of ABTL0812 plus paclitaxel + carboplatin in patients with advanced or metastatic endometrial cancer or squamous NSCLC at first line therapy
    To evaluate the pharmacokinetics of ABTL0812
    To evaluate biomarkers to monitor activity ABTL0812
    To evaluate biomarkers for response prediction to ABTL0812
    To determine the recommended Phase II Dose (RP2D) of ABTL0812 plus paclitaxel + carboplatin
    Evaluar la eficacia de ABTL0812 en combinación con paclitaxel + carboplatino en pacientes con cáncer avanzado de endometrio o cáncer escamoso de pulmón
    Evaluar la farmacocinética de ABTL0812
    Evaluar los biomarcadores para monitorizar actividad de ABTL0812
    Evaluar los biomarcadores predictivos de respuesta a ABTL0812
    Determinar la dosis recomendada de fase II de ABTL0812 en combinación con paclitaxel + carboplatino
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients ≥18 years of age
    For endometrial cancer: Patients with histologically or radiological/cytologically confirmed diagnosis of advanced, metastatic or recurrent endometrial cancer
    For squamous NSCLC: Patients with histologically or radiological/cytologically confirmed diagnosis (non irradiable IIIb stage or stage IV)
    Have adequate tumor tissue available (either archival or new tumor biopsy) for biomarker analyses.
    Life expectancy ≥ 12 weeks in the opinion of the investigator
    Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 guidelines with at least one "target lesion" to be used to assess response.
    Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
    Contraception: Female patients of childbearing potential must agree to use two forms of highly effective contraception methods during the study and for a period of 6 months following the last administration of the study drug.
    Adequate bone marrow function defined as:
    - absolute neutrophil count ≥ 1.5x109/L
    - platelet count ≥ 100x109/L
    - hemoglobin ≥ 9.0 g/dL
    Total bilirubin ≤ 1.5 x upper limit of normal
    AST ≤ 2.5 times upper limit of normal (ULN) (≤5 times the ULN in patients with evidence of liver metastases)
    Alkaline phosphatase ≤ 2.5 times ULN (≤5 times the ULN in patients with evidence of liver metastases)
    Glomerular filtration rate ≥ 50 mL/min
    Serum creatinine ≤1.5 mg/dL
    Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common Terminology Criteria for Adverse Events version 4.02).
    Pacientes 18 años o mayores.
    Para cáncer de endometrio: pacientes con diagnóstico confirmado por histología o radiología / citología de cáncer de endometrio avanzado, metastático o recurrente.
    Para cáncer escamoso de pulmón: Pacientes con diagnóstico confirmado por histología o radiología / citología (no irradiable estadío IIIb o IV)
    Suficiente tejido tumoral (de archivo o nueva biopsia) para análisis de biomarcadores.
    Esperanza de vida ≥ 12 semanas en opinión del investigador
    Enfermedad medible con la Guía RECIST)Versión 1.1, con al menos una "lesión diana" que se utilizará para evaluar la respuesta.
    Estado ECOG Rendimiento 0-1.
    Anticoncepción: Toda paciente del sexo femenino en edad fértil deben usar dos formas de métodos anticonceptivos altamente eficaces durante el estudio y durante un período de 6 meses después de la última administración del fármaco del estudio.
    Función de la médula ósea adecuada definida como:
    - Recuento absoluto de neutrófilos ≥ 1.5x109/L
    - Recuento de plaquetas ≥ 100x109/L
    - Hemoglobina ≥ 9,0 g/dl
    Bilirrubina total ≤ 1,5 x límite superior normal.
    AST ≤ 2,5 veces el límite superior de la normalidad (ULN) (≤ 5 veces el límite superior normal en pacientes con evidencia de metástasis hepáticas).
    Fosfatasa alcalina ≤ 2,5 veces el ULN (≤ 5 veces el límite superior normal en pacientes con evidencia de metástasis hepáticas).
    Tasa de filtración glomerular ≥ 50 mL/min.
    Creatinina sérica ≤1.5 mg/dl.
    Las toxicidades incurridas como resultado de un tratamiento previo contra el cáncer (radioterapia, quimioterapia o cirugía) deben ser resueltas a grado ≤1 (como se define por criterios de Terminología Común para Eventos Adversos de la versión 4.02).




    Respuesta medible por RECIST Version 1.1 con
    s with at least one "target lesion" to be used to assess response. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented.
    Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
    Contraception: All female patients will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months’ consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically. Female patients of childbearing potential must agree to use two forms of highly effective contraception methods during the study and for a period of 6 months following the last administration of the study drug. Male patients and their female partners, who are of childbearing potential and are not practicing total abstinence, must agree to use two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug.
    Adequate bone marrow function defined as:
    - absolute neutrophil count ≥ 1.5x109/L
    - platelet count ≥ 100x109/L
    - hemoglobin ≥ 9.0 g/dL
    Total bilirubin ≤ 1.5 x upper limit of normal
    AST ≤ 2.5 times upper limit of normal (ULN) (≤5 times the ULN in patients with evidence of liver metastases)
    Alkaline phosphatase ≤ 2.5 times ULN (≤5 times the ULN in patients with evidence of liver metastases)
    Glomerular filtration rate ≥ 50 mL/min
    Serum creatinine ≤1.5 mg/dL
    Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common Terminology Criteria for Adverse Events version 4.02).
    Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol
    E.4Principal exclusion criteria
    Patients previously treated with an inhibitor of the PI3K/Akt/mTOR pathway.
    Patients with symptomatic brain metastases.
    Patients with gastrointestinal abnormalities including inability to take oral medications, malabsorption syndromes or other clinically significant gastrointestinal abnormalities that may impair the absorption of the investigational medicinal product.
    Pregnancy or lactation.
    Patients with myocardial infarction within ≤ 12 months prior to study entry, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina pectoris, or unstable cardiac arrhythmia requiring medication.
    Evidence of pre-existing uncontrolled hypertension.
    Patients with known Hepatitis B or C or human immunodeficiency virus (HIV) infection with non-controlled disease according to the treating physician.
    Patients with any other medical conditions (such as psychiatric illness, infectious diseases, abnormal physical examination or laboratory findings) that in the opinion of the investigator may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
    Pacientes previamente tratados con un inhibidor de la vía PI3K/Akt/mTOR.
    Pacientes con metástasis cerebrales sintomáticas.
    Pacientes con alteraciones gastrointestinales incluyendo la incapacidad de tomar medicamentos orales, síndromes de mala absorción u otras anomalías gastrointestinales clínicamente significativos que perjudiquen la absorción del medicamento en investigación.
    Embarazo o lactancia.
    Pacientes con infarto de miocardio en ≤ 12 meses anteriores al ingreso al estudio, insuficiencia cardíaca congestiva sintomática (New York Heart Association > clase II), angina de pecho inestable o arritmia cardiaca inestable que requiere medicación.
    Evidencia de hipertensión no controlada preexistente.
    Pacientes con Hepatitis B o C conocida o infección por el virus de la inmunodeficiencia humana (VIH), no adecuadamente controlada en opinión de su médico.
    Pacientes con otras patologías (como enfermedades psiquiátricas, enfermedades infecciosas, con hallazgos en el examen físico o de laboratorio anormales) que, en opinión del investigador, puede interferir con el tratamiento previsto, afectar al cumplimiento del paciente o exponer al paciente a un alto riesgo de complicaciones relacionadas con el tratamiento del ensayo
    E.5 End points
    E.5.1Primary end point(s)
    To assess safety and tolerability of ABTL0812 plus paclitaxel + carboplatin in patients with advanced or metastatic endometrial cancer or squamous NSCLC at first line therapy
    Evaluar la seguridad y tolerabilidad de ABTL0812 más paclitaxel + carboplatino (tratamiento estándar, SOC) en pacientes con cáncer de endometrio avanzado o metastásico o NSCLC escamoso en la terapia de primera línea.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: every 3 weeks
    Phase II: every 2 months
    Fase I: cada 3 semanas
    Fase II: cada 2 meses
    E.5.2Secondary end point(s)
    1. To evaluate the efficacy of ABTL0812 plus paclitaxel + carboplatin in patients with advanced or metastatic endometrial cancer or squamous NSCLC at first line therapy
    2. To evaluate the pharmacokinetics of ABTL0812
    3. To evaluate biomarkers to monitor activity ABTL0812
    4. To evaluate biomarkers for response prediction to ABTL0812
    5. To determine the recommended Phase II Dose (RP2D) of ABTL0812 plus paclitaxel + carboplatin
    1. Evaluación de la eficacia de ABTL0812 en combinación paclitaxel + carboplatino
    2. Evaluación de la farmacocinética de ABTL0812
    3. Evaluación de los biomarcadores para monitorizar la actividad de ABTL0812
    4. Evaluación de los biomarcadores predictivos de respuesta a ABTL0812
    5. Determinación de la dosis recomendada para la fase II en combinación con paclitaxel + carboplatin
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Every 2 months aprox.
    2. At study innitiation and 1 month after
    3. At study innitiation and 1 month after
    4. At study innitiation
    5. At the end of de-escalation phase (phase I)
    1. Cada dos meses aproximadamente
    2. Al inicio del estudio y un mes después
    3. Al inicio del estudio y un mes después
    4. Al inicio del estudio
    5. Al final de la fase de desescalado (fase I)
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Toleability and safety
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state80
    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)
    Follow up visit 30 days after the patient ends treatment
    Visita de seguimiento 30 días después de que el paciente termina el tratamiento
    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 Decision2016-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-28
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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