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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2009-018171-13
    Sponsor's Protocol Code Number:ONCOSUR-B-001-09
    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:2010-02-24
    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 number2009-018171-13
    A.3Full title of the trial
    Estudio clínico de fase IIa, del tratamiento con heparina topica en pacientes con sindrome eritrodisestesico palmo-plantar asociado a capecitabina
    A.4.1Sponsor's protocol code numberONCOSUR-B-001-09
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorONCOSUR
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 MENAVEN GEL 1000
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS MENARINI 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 Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPARINA SODICA
    D.3.9.1CAS number 9041-08-1
    D.3.9.3Other descriptive nameHEPARIN SODIUM
    D.3.10 Strength
    D.3.10.1Concentration unit IU/g international unit(s)/gram
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    síndrome eritrodisestésico palmo-plantar
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10033553
    E.1.2Term Palmar-plantar erythrodysaesthesia syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la mejoría clínica asociada al tratamiento con heparina tópica a las tres semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad del tratamiento tópico con heparina sodica en pacientes SPP secundario a capecitabina.
    Evaluar las reducciones de dosis o retrasos del tratamiento con capecitabina asociados al SPP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consentimiento informado por escrito.
    2. Edad >= 18 años
    3. Estado funcional del ECOG de 0 a 2.
    4. Cáncer confirmado histológica o citológicamente.
    5. Paciente en tratamiento con capecitabina en cualquier esquema de administración, como agente único o en combinación.
    6. Presencia de Eritrodisestesia Palmo-Plantar (SPP) en grado 1 o 2 según los criterios NCI-CTCAE (vs. 4.0).
    E.4Principal exclusion criteria
    1. Mujeres embarazadas o en período de lactancia.
    2. Pacientes en edad fértil deberán aceptar el uso de un método anticonceptivo adecuado durante el tratamiento con el fármaco del estudio y hasta 1 mes después de haber finalizado el tratamiento.
    3. Pacientes que se encuentren recibiendo tratamiento activo dentro de un ensayo clínico.
    4. Funciones orgánicas inadecuadas:
    Albúmina <2,5 g/dl.
    Recuento de plaquetas <75 x 109/l
    APTT o INR > 1,5 x LSN.
    5. Sistema nervioso periférico: Neuropatía periférica de grado >= 2 según los CTC del NCI versión 4.0.
    6. Purpura de cualquier etiología
    7. Lesiones sangrantes en palmas o plantas.
    8. Pruebas de cualquier otra enfermedad, disfunción metabólica o psicológica, hallazgo en la exploración física o de las pruebas del laboratorio clínico que lleven a la sospecha razonable de una enfermedad o proceso que contraindique el uso de un fármaco en investigación, que puedan afectar al cumplimiento por el paciente de las rutinas del estudio, o que pongan a la paciente en grave riesgo de sufrir complicaciones relacionadas con el tratamiento.
    9. Hipersensibilidad conocida a Heparina, o antecedentes de trombopenia asociada a heparina.
    10. Deficiencia conocida de DPD.
    11. Cualquier otro fármaco en investigación, corticosteroides de manera crónica.
    12. Eritrodisestesia Palmo-Plantar debido a cualqiuier otro fármaco distinto de Capecitabina.
    13. Otros fármacos para el tratamiento de la EPP (vitamina B6 o productos con urea o ácido lático) u otros fármacos tópicos para manos y pies con cualquier otra indicación (ej. Sequedad de piel).
    14. Incapacidad de cumplir el tratamiento y los procedimientos protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Mejoría clínica a las tres semanas
    Tiempo hasta la mejoría del SPP.
    Mejoría percibida por el paciente (escala analógica visual).
    Reducciones de dosis o retrasos del tratamiento con capecitabina asociados al SPP.
    Uso de medicaciones para dolor y otros tratamientos sintomáticos del SPP.
    Ocurrencia de eventos adversos asociados al tratamiento con HT.
    Variaciones histopatológicas durante el tratamiento con HT en la piel afecta por el SPP.
    Variaciones de expresión de proteinas potencialmente asociadas a la fisiopatología del SPP. (DPD, TP, FGF y KGF) en biopsias cutanéas y sangre periferica.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-02-24. Yes
    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 state21
    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 Decision2010-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-08
    P. End of Trial
    P.End of Trial StatusOngoing
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