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    Summary
    EudraCT Number:2021-005999-18
    Sponsor's Protocol Code Number:PI20/01514
    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:2022-02-07
    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 number2021-005999-18
    A.3Full title of the trial
    Effect of obesity on COX1 and 2 acetylation by aspirin as a biomarker of its efficacy in colon cancer chemoprevention and therapy.
    Efecto de la obesidad en la acetilación de la COX1 y 2 por aspirina como biomarcador de su eficacia en la quimioprevención y terapia en el cáncer de colon.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of obesity on aspirin action and its efficacy in colon cancer therapy
    Efecto de la obesidad por acción de la aspirina y su eficacia en la terapia para el tratamiento del cáncer de colon.
    A.3.2Name or abbreviated title of the trial where available
    COXOB
    COXOB
    A.4.1Sponsor's protocol code numberPI20/01514
    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 SponsorInstituto de Investigación Sanitaria Aragón
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigación Sanitaria Aragón
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressAvda/ San Juan Bosco 13, Edificio CIBA, IIS Aragon, Planta Baja
    B.5.3.2Town/ cityZaragoza
    B.5.3.3Post code50009
    B.5.3.4CountrySpain
    B.5.4Telephone number34976716818
    B.5.6E-maileandres@iisaragon.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 Adiro 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Hispania, 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 Gastro-resistant capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Adiro 300 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Hispania 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 Gastro-resistant capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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 Adiro 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Hispania, 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 Gastro-resistant capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Colorectal cancer
    Cáncer colorectal
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    Cáncer colorectal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    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 evaluate the effect of a short course (one week) of acetylsalicylic acid at different doses on platelet activation and platelet COX-1 activity in patients diagnosed with colorectal cancer, comparing these effects in obese and non-obese patients.
    Evaluar el efecto de un curso corto (una semana) de ácido acetilsalicílico a diferentes dosis sobre la activación plaquetaria y la actividad COX-1 plaquetaria en pacientes diagnosticados de cáncer colorectal, comparando estos efectos en pacientes obesos y no obesos.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of acetylsalicylic acid on indirect biomarkers of its action at the systemic level.
    - To investigate the role of inflammatory and anti-inflammatory cytokines in platelet activation.
    - To investigate the degree of COX1/2 acetylation in normal and tumour tissue after exposure of patients to acetylsalicylic acid.
    - Evaluar el efecto del ácido acetilsalicílico sobre biomarcadores indirectos de su acción a nivel sistémico.
    - Investigar el papel de las citoquinas inflamatorias y antiinflamatorias en la activación de plaquetas.
    - Investigar el grado de acetilación de COX1 / 2 en el tejido normal y tumoral después de la exposición de los pacientes al ácido acetilsalicílico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years and < 80 years.
    - Recent diagnosis (< 24 h) of colon or rectal cancer, established by endoscopy, and subsequently confirmed by anatomo-pathological study.
    - Coagulation study within the normal range and usual biochemical parameters without clinically significant deviations that, at the investigator's discretion, could interfere with the study procedures.
    - In the obese group, patients with BMI ≥ 30 will be selected. In the non-obese group, patients with BMI ≤ 25 will be selected.
    - Edad ≥ 18 años y < 80 años.
    - Diagnostico reciente (< 24 h) de cáncer de colon o recto, establecido mediante endoscopia, y confirmado posteriormente por estudio anatomo-patológico.
    - Estudio de coagulación dentro del rango de la normalidad y parámetros bioquímicos habituales sin desviaciones clínicamente significativas que a criterio del investigador puedan interferir en los procedimientos del estudio.
    - En el grupo de obesos se seleccionarán pacientes con IMC ≥ 30. En el grupo de no obsesos pacientes con IMC ≤ 25.
    E.4Principal exclusion criteria
    -Allergy to acetylsalicylic acid or other NSAIDs.
    -Rectal cancer requiring neoadjuvant treatment within three weeks of starting acetylsalicylic acid treatment.
    -Previous use of acetylsalicylic acid, NSAIDs, antiplatelet agents, corticosteroids or misoprostol in the 15 days prior to diagnosis and/or anticipated need for treatment with any of these drugs during the study period.

    -History of peptic ulcer or active peptic ulcer or any other GI disease that may be considered a contraindication to the use of acetylsalicylic acid, without concomitant use of proton pump inhibitors.
    -Diagnosis of bleeding disorders.
    -Diagnosis of cancer (excluding non-melanoma skin cancer) within the previous 3 years.
    -Alergia a ácido acetilsalicílico o a algún otro AINE.
    -Cáncer rectal que requiera tratamiento neoadyuvante en las tres semanas siguientes al inicio del tratamiento con ácido acetilsalicílico.
    -Uso previo de ácido acetilsalicílico, AINEs, agentes antiplaquetarios, corticosteroides o misoprostol en los 15 días anteriores al diagnóstico y/o previsión de necesidad de tratamiento con alguno de estos fármacos durante el periodo de estudio.
    -Historia de úlcera péptica o úlcera péptica activa o cualquier otra enfermedad GI que pueda considerarse contraindicación para el uso de ácido acetilsalicílico, sin el uso concomitante de inhibidores de la bomba de protones.
    -Diagnóstico de trastornos hemorrágicos.
    -Diagnóstico de cáncer (excluyendo cáncer de piel no melanoma) en los 3 años previos.
    E.5 End points
    E.5.1Primary end point(s)
    -Assessment of the level of COX enzyme acetylation in platelets and healthy and tumour colonic tissue as biomarkers of clinical efficacy.
    -Safety variables include analytical determinations with haemogram, biochemistry (blood and urine), microbiology and pregnancy test prior to inclusion in the trial, in order to detect abnormalities that imply exclusion criteria for the individual.
    -Evaluación del nivel de acetilación de las enzimas COX en plaquetas y tejido colónico sano y tumoral, como biomarcadores de eficacia clínica.
    -Las variables de seguridad incluyen determinaciones analíticas con hemograma, bioquímica (sangre y orina), microbiología y test de embarazo antes de la inclusión en el ensayo, con el objeto de detectar anomalías que impliquen criterios de exclusión del individuo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before the beginning of the treatment and 3-4 weeks of acetylsalicylic acid treatment
    Antes del comienzo del tratamiento y tras 3-4 semanas de tratamiento con ácido acetilsalicílico
    E.5.2Secondary end point(s)
    -Evaluation of PGE2 level and S6 protein phosphorylation status in colorectal mucosa depending on obesity and ASA dose.
    -Evaluation of the effect of obesity and ASA dose on indirect biomarkers at systemic level (TXB2, TX-M, PGE-M and platelet aggregation).
    -Evaluación del nivel de PGE2 y del estado de fosforilación de la proteína S6 en mucosa colorrectal dependiendo de la obesidad y dosis de AAS
    -Evaluación del efecto de la obesidad y dosis de AAS sobre biomarcadores indirectos a nivel sistémico (TXB2, TX-M, PGE-M y agregación plaquetaria)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before the beginning of the treatment and 3-4 weeks of acetylsalicylic acid treatment
    Antes del comienzo del tratamiento y tras 3-4 semanas de tratamiento con ácido acetilsalicílico
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3.1Comparator description
    Adiro
    Adiro
    E.8.2.4Number of treatment arms in the trial3
    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 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
    The last visit of the last patient. This is the start up of the study.
    La última visita del último participante del ensayo clínico.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state60
    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 Decision2022-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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