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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2022-001107-41
    Sponsor's Protocol Code Number:IMIB-BICOV-2022-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-13
    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 number2022-001107-41
    A.3Full title of the trial
    Combined treatment of intraperitoneal chemotherapy after optimal interval surgery in advanced ovarian cancer
    Esquema combinado de quimioterapia intraperitoneal tras cirugía de intervalo óptimo en cáncer de ovario avanzado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combined treatment of intraperitoneal chemotherapy after optimal interval surgery in advanced ovarian cancer
    Esquema combinado de quimioterapia intraperitoneal tras cirugía de intervalo óptimo en cáncer de ovario avanzado
    A.3.2Name or abbreviated title of the trial where available
    BICOV-1
    BICOV-1
    A.4.1Sponsor's protocol code numberIMIB-BICOV-2022-01
    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 SponsorFundación para la Formación e Investigación Sanitarias de la Región de Murcia (FFIS)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEVOMED
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPlataforma EECC IMIB
    B.5.2Functional name of contact pointMaria Muñoz
    B.5.3 Address:
    B.5.3.1Street AddressCtra. Madrid-Cartagena s/n
    B.5.3.2Town/ cityEl Palmar - Murcia
    B.5.3.3Post code30120
    B.5.3.4CountrySpain
    B.5.4Telephone number34968381290
    B.5.6E-mailmaria.munoz@imib.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 Yes
    D.2.1.1.1Trade name Cisplatino
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia Nostrum, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCisplatino
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConcentrate for solution for infusion (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Paclitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderHOSPIRA INVICTA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePaclitaxel
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConcentrate for solution for infusion (Noncurrent)
    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
    Ovarian cancer (OV-1)
    Cáncer de ovario (OV-1)
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer (OV-1)
    Cáncer de ovario (OV-1)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10070907
    E.1.2Term Ovarian cancer 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10070908
    E.1.2Term Ovarian cancer stage IV
    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 investigate whether the combined administration of HIPEC with CISPLATINO (100mgr/m2 body surface area) and postoperative bidirectional chemotherapy (intraperitoneal and systemic) after complete cytoreduction is feasible, effective and safe in patients with IIIB‐C/IV ovarian cancer treated with systemic chemotherapy. neoadjuvant.
    Investigar si la administración combinada de HIPEC con CISPLATINO (100mgr/m2 de superficie corporal) y quimioterapia bidireccional postoperatoria (intraperitoneal y sistémica) tras citorreducción completa es factible, efectiva y segura en pacientes con cáncer de ovario IIIB‐C/IV tratadas con quimioterapia sistémica neoadyuvante.
    E.2.2Secondary objectives of the trial
    Evaluate patients' life quality before surgery, before the start of chemotherapy treatment and after its completion (3 and 6 months).
    Evaluar los parámetros de Calidad de Vida de las pacientes antes de la cirugía, antes del inicio del tratamiento y después de su finalización (3 y 6 meses).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ‐ Women aged between 18‐70 years with a proven histological diagnosis of FIGO stage IIIB‐C/IV epithelial ovarian cancer (high grade serous epithelial carcinoma).
    ‐ Absence of extraperitoneal disease.
    ‐ Good functional status: Karnofsky index >70 or Performance status <=2.
    ‐ Optimal liver function, defined as bilirubin <0 1.5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase <= 2.5 times ULN, and alkaline phosphatase <=3 times ULN.
    ‐ Mujeres entre 18‐70 años con diagnóstico histológico probado de cáncer epitelial de ovario estadío IIIB‐C/IV FIGO (carcinoma epitelial seroso de alto grado).
    ‐ Ausencia de enfermedad extraperitoneal.
    ‐ Buen estado funcional: Índice Karnofsky >70 o Performance status <=2.
    ‐ Función hepática correcta, definida como bilirrubina <0 1,5 veces el límite superior de normalidad (LSN), aspartato amino transferasa y alaninoaminotransferasa <=2,5 veces LSN, y fosfatasa alcalina <=3 veces LSN.
    - Función renal correcta, definida como creatinina sérica <= 1,5 veces LSN.
    ‐ Función de la médula ósea aceptable definida como neutrófilos >1,5 x 106 l‐1 hemoglobina > 10 g/dl‐1 y plaquetas > 100.0 x 109 l‐1.
    ‐ Ausencia de enfermedad cardiaca, pulmonar, hepática, renal o neurológica que contraindique la cirugía mayor.
    ‐ Resultado negativo en prueba de embarazo en suero y orina para mujeres en edad fértil en visita de screening.
    ‐ Administración de quimioterapia neoadyuvante con un total de 3 o 4 ciclos sistémicos.
    ‐ Cirugía con citorreducción completa CC0 SIN ANASTOMOSIS DIGESTIVAS.
    ‐ Pacientes que hayan firmado el consentimiento informado por escrito (CI).
    E.4Principal exclusion criteria
    - Disease progression during systemic treatment with neoadjuvant chemotherapy.
    ‐ Extraperitoneal disease (including retroperitoneal lymph node metastases).
    ‐ Impossibility of achieving complete cytoreduction (CC‐0), in the preoperative evaluation (imaging tests), or intraoperatively.
    ‐ Conduct of at least one digestive anstomosis of any nature.
    ‐ Active infection of any origin.
    ‐ Allogeneic transplant, or previous bone marrow transplant, or high dose chemotherapy with bone marrow or stem cell rescue.
    ‐ Beeing enrroled in a clinical trial with an investigational drug in the last 30 years.
    - Not having given writing informed consent.
    - Progresión de la enfermedad durante el tratamiento sistémico con quimioterapia neoadyuvante.
    ‐ Enfermedad extraperitoneal (incluidas las metástasis ganglionares retroperitoneales).
    ‐ Imposibilidad de conseguir una citorreducción completa(CC‐0), en la evaluación preoperatoria (pruebas de imagen), o intraoperatoria.
    ‐ Realización de al menos, una anstomosis digestiva de cualquier naturaleza.
    ‐ Infección activa de cualquier origen.
    ‐ Trasplante alogénico, o Trasplante de médula ósea previo, o quimioterapia a altas dosis con rescate de médula ósea o células madre.
    ‐ Participación en ensayo clínico con un fármaco en investigación en los últimos 30 años.
    ‐ No firma del consentimiento informado por escrito.
    E.5 End points
    E.5.1Primary end point(s)
    - The safety variable of the study will be postoperative Morbidity and Mortality. Morbidity will be defined based on the NCI‐CTCAE v4 scale classification. Minor complications will be considered those that require only medical treatment for their resolution (grade II) and moderate complications those that require invasive procedures, such as percutaneous drainage guided by ECHO/CT, placement of a pleural drainage tube or therapeutic endoscopy (grade III) . Serious complications (grade IV) will be those that require a new surgical intervention or admission of the patient to the ICU for their resolution. Causes of death related to the procedure (mortality) will be those that occur before the patient's hospital discharge or within the first 30 days after hospital discharge. The causes of death will also be reflected.
    - The variables related to the treatment effectiveness will be disease-free and overall survival.
    - La variable de seguridad del estudio será la Morbilidad y Mortalidad postoperatorias. La morbilidad se definirá en base a la clasificación la escala NCI‐CTCAE v4). Se considerarán complicaciones menores aquellas que precisen para su resolución solamente tratamiento médico (grado II) y complicaciones moderadas aquellas que precisen procedimientos invasivos, como el drenaje percutáneo guiado por ECO/TAC, colocación de un tubo de drenaje pleural o endoscopia terapéutica (grado III). Las complicaciones graves (grado IV) serán aquellas que precisen para su resolución una nueva intervención quirúrgica o el ingreso de la paciente en UCI. Serán causas de fallecimiento relacionadas con el procedimiento (mortalidad) aquellas que acontezcan antes del alta hospitalaria de la paciente o dentro de los primeros 30 días desde el alta hospitalaria. Se reflejará así mismo las causas del fallecimiento.
    - Las variables relacionadas con la efectividad del tratamiento serán la supervivencia libre de enfermedad y global.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 years
    5 años
    E.5.2Secondary end point(s)
    The secondary variable will be the patients' life quality once treatment finished, evaluated using the EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires.
    La variable secundaria será la calidad de vida de los pacientes tras finalizar el tratamiento, evaluada mediante los cuestionarios EORTC QLQ‐C30 y EORTC QLQ-CR29.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3-6 months
    3-6 meses
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Bajo nivel de intervención
    Low-intervention clinical trial
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    None
    Ninguno
    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 Decision2022-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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