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    The EU Clinical Trials Register currently displays   35474   clinical trials with a EudraCT protocol, of which   5826   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-004321-83
    Sponsor's Protocol Code Number:GEFCAPI04
    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:2013-12-05
    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 number2013-004321-83
    A.3Full title of the trial
    A randomised phase III trial comparing a strategy based on molecular analysis to the empiric strategy in patients with carcinoma of an unknoun primary (CUP)
    Ensayo Clínico Aleatorizaco de Fase III comparando una estrategia basada en el análisis molecular con la estrategia empírica en pacientes con carcinoma de origen primario desconocido (CUP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CUP Trial
    Ensayo CUP
    A.4.1Sponsor's protocol code numberGEFCAPI04
    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 SponsorInstitut Català d'Oncologia (ICO)
    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 supportInstitu Català d'Oncologia (ICO)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMFAR S.L.
    B.5.2Functional name of contact pointFederico Nepote
    B.5.3 Address:
    B.5.3.1Street Addressc/ Secretari Coloma, 64-68, escalera B, entlo. 5ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08024
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934 34 44 12
    B.5.5Fax number0034932 53 11 68
    B.5.6E-mailinvestigacion@mfar.net
    D. IMP Identification
    D.IMP: 1
    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 Cisplatino Ferrer Farma 1mg/ml, concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Farma, 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.3.4Pharmaceutical form Suspension 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 INNCISPLATIN
    D.3.9.2Current sponsor codePR1
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Gemcitabina STADA polvo para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorio STADA, S.L.
    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.3.4Pharmaceutical form Powder for solution for injection/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.3.9.2Current sponsor codePR2
    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
    Carcinomas of an unknown primary site (CUP)
    Carcinomas de origen primario desconocido
    E.1.1.1Medical condition in easily understood language
    Cancer which first localization remains unknown
    Cáncer en donde la localización primaria es desconocida
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare empiric chemotherapy regimen in patient with CUP (cisplatin-gemcitabine) with standard treatment of the primary suspected by molecular analysis, by means of PFS
    Comparar régimen empírico de la quimioterapia con la estrategia basada por el análisis molecular en pacientes con carcinoma de origen primario desconocido (cisplatino-gemcitabina) mediante la SLP
    E.2.2Secondary objectives of the trial
    Response Rate, tolerance, overall survival, pharmacogenomics, translational study.
    Tasa de respuestas, tolerancia, supervivencia global, farmacogenómica y estudios traslacionales
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Blood-sample sub-study, version 3.0, date 21 /06 /2013
    Objectives: Identify genetic factors involved in the response to treatment with gemcitabine and cisplatin.

    Tumor-sample sub-study, version 3.0, date 21 /06 /2013
    Objectives: Validate an academic test which determine the most likely tumor site.
    Estudio de muestras sanguíneas, versión 3.0 del 21/06/2013
    Objetivos: Identificar los factores genéticos implicados en la respuesta al tratamiento con gemcitabina y cisplatino.

    Estudios de muestras de tumor, versión 3.0 del 21/06/2013
    Objetivos: Validar un estudio académico que determine la localización primaria mas probable.
    E.3Principal inclusion criteria
    1) Patients presenting with carcinoma of an unknown primary, confirmed by histo-pathological analysis (including an immunohistochemical analysis) and corresponding to one of the following histologic types: moderately or well-differentiated adenocarcinoma, poorly-differentiated adenocarcinoma, undifferentiated carcinoma, squamous-cell carcinoma.
    2) Diagnostic work-up in keeping with Standard Options Recommandations des CAPI (Lesimple et al., 2003).
    3) Age>18 years.
    4) Performance status 0, 1 or 2 according to ECOG.
    5) Good or poor prognosis CUP classified according to the GEFCAPI classification.
    6) CUP with at least one measurable lesion.
    7) Tumour sample available for molecular analysis.
    8) CUP not belonging to a subgroup requiring a specific treatment.
    9) Satisfactory haematological, renal and hepatic function.
    10) Cardiac, respiratory and neurological function compatible with the administration of cisplatin chemotherapy.
    11) No previous chemotherapy, for CUP.
    12) Previous radiotherapy is acceptable, but it should be completed at least 4 weeks before the start of systemic treatment. Randomisation can be performed during this time frame.
    13) All patients with reproductive potential must practice an effective method of birth control throughout the study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment.
    14) Information delivered to patient and informed consent form signed by the patient or legal representative.
    1 ) Los pacientes que presentan carcinoma de localización primaria desconocida, confirmados por análisis histopatológico (incluyendo un análisis inmunohistoquímico) y que corresponda a uno de los siguientes tipos histológicos: adenocarcinoma moderadamente o bien diferenciado, adenocarcinoma pobremente diferenciado, carcinoma indiferenciado, carcinoma de células escamosas.
    2 ) Diagnóstico en consonancia con las recomendaciones estándar de CAPI (Lesimple et al. , 2003).
    3 ) Edad> 18 años .
    4 ) Estado funcional 0, 1 o 2 de acuerdo con ECOG .
    5 ) CUP de buen o mal pronóstico de acuerdo a la clasificación GEFCAPI .
    6 ) CUP con al menos una lesión medible.
    7 ) Muestra disponible para el análisis molecular del tumor .
    8 ) CUP que no pertenecen a un subgrupo que requiere un tratamiento específico.
    9 ) Adecuada función hematológica, renal y hepática .
    10 ) Función cardiaca, respiratoria y neurológica compatible con la administración de quimioterapia con cisplatino.
    11 ) Ausencia de quimioterapia previa para CUP.
    12 ) Se acepta radioterapia previa, pero debe haberse completado al menos 4 semanas antes del inicio del tratamiento sistémico. La aleatorización se puede realizar durante este intervalo de tiempo.
    13 ) Todos los pacientes con potencial reproductivo deben practicar un método efectivo de control de la natalidad durante todo el estudio. Mujeres en edad fértil deben disponer de una prueba de embarazo negativa, en los 7 días previos al inicio del tratamiento a estudio.
    14) Firma del Consentimiento Informado por el paciente o su representante legal
    E.4Principal exclusion criteria
    1) Patients in whom the diagnosis has not been histologically confirmed (a cytological analysis alone does not permit patient entry onto the trial).
    2) Patients with known HIV infection.
    3) Patients with symptomatic brain metastases.
    4) Associated disease likely to prevent the patient from receiving the treatment.
    5) Previous history of cancer (excepted skin basocellular epithelioma or epithelioma in situ of the uterine cervix) during the 5 years before study entry.
    6) Patients already included in another clinical trial with an experimental therapy.
    7) Pregnant women, and women who are breastfeeding.
    8) Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons.
    1) Pacientes en los que el diagnóstico no se ha confirmado histológicamente (un análisis citológico solo, no permite la entrada de pacientes en el ensayo).
    2) Pacientes con infección por VIH conocida.
    3) Pacientes con metástasis cerebrales sintomáticas.
    4) Enfermedad concurrente que impidan que el paciente reciba el tratamiento.
    5) Historia previa de cáncer en los 5 años anteriores al ingreso al estudio (excepto: epitelioma basocelular de piel o epitelioma in situ del cuello uterino)
    6) Pacientes ya incluidos en otro ensayo clínico con terapia experimental.
    7) Las mujeres embarazadas y/o en período de lactancia.
    8) Imposibilidad de cumplir con el seguimiento médico del ensayo debido a a razones geográficas, sociales o psicológicas.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival according to RECIST criteria v1.1.
    Supervivencia libre de progresión según criterios RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    5.5 years
    5.5 años
    E.5.2Secondary end point(s)
    1. Response rate (RECIST criteria) v1.1.
    2. Tolerance (NCI-CTC criteria version 4.0).
    3. Overall survival.
    4. Pharmacogenomics: Genetic polymorphisms in genes involved in cisplatin and gemcitabine metabolism (blood lymphocytes).
    5. Translational studies.
    6. Medico-economic study (Medical costs and utilities).
    1. Tasa de respuestas (según RECIST V 1.1)
    2. Tolerancia (NCI-CTC versión 4.0)
    3. Supervivencia Global
    4. Farmacogenómica: Polimorfismos genéticos implicados en el metabolismo de cisplatino y gemcitabina (linfocitos)
    5. Estudios traslacionales
    6. Estudios medico-económicos (recursos médicos utilizados)
    E.5.2.1Timepoint(s) of evaluation of this end point
    5.5 years
    5.5 años
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 No
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 years5
    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: 223
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 223
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 193
    F.4.2.2In the whole clinical trial 233
    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)
    Clinical normal practise
    Práctica clínica habitual
    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 Decision2014-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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