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    Summary
    EudraCT Number:2021-001328-17
    Sponsor's Protocol Code Number:IMIB-HTF-2021-01
    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:2021-09-16
    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 number2021-001328-17
    A.3Full title of the trial
    Histological and clinical effects of Imipramine in the treatment of patients with cancer over-expressing Fascin1.
    Efectos clínicos e histológicos de la Imipramina en el tratamiento de pacientes con cáncer que sobreexpresan Fascina1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Histological and clinical effects of Imipramine in the treatment of patients with cancer over-expressing Fascin1.
    Efectos clínicos e histológicos de la Imipramina en el tratamiento de pacientes con cáncer que sobreexpresan Fascina1.
    A.3.2Name or abbreviated title of the trial where available
    HITCLIF
    HITCLIF
    A.4.1Sponsor's protocol code numberIMIB-HTF-2021-01
    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
    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 supportISCarlos III
    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 Imipramine
    D.2.1.1.2Name of the Marketing Authorisation holderAmdipharm Limited
    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 nameImipramine
    D.3.4Pharmaceutical form Capsule, hard
    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 INNIMIPRAMINE
    D.3.9.1CAS number 50-49-7
    D.3.9.4EV Substance CodeSUB08152MIG
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Colorectal cancer and triple negative breast cancer patients (TNBC) who shown overexpression of fascin1 in the diagnostic biopsy tissue.
    Pacientes con cáncer colorrectal y con cáncer de mama triple negativo (TNBC) que muestran sobreexpresión de fascina1 en el tejido de biopsia diagnóstica.
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer and triple negative breast cancer patients (TNBC) who shown overexpression of fascin1 in the diagnostic biopsy tissue.
    Pacientes con cáncer colorrectal y con cáncer de mama triple negativo (TNBC) que muestran sobreexpresión de fascina1 en el tejido de biopsia diagnóstica.
    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
    Evaluate the effect of the imipramine treatment on the development of histological manifestations associated with the mesenchymal epithelial transition during the period of time from the analysis of the diagnostic biopsy to the surgical resection intervention.
    Evaluar el efecto del tratamiento de la imipramina sobre el desarrollo de manifestaciones histológicas asociadas con la transición epitelio-mesénquima durante el periodo de tiempo desde el análisis de la biopsia diagnóstica hasta la intervención de resección quirúrgica.
    E.2.2Secondary objectives of the trial
    1. Monitoring of minimal residual disease using circulating DNA: It will be analysed by liquid biopsy quantification and digital PCR of those mutations found in the primary tumour.
    2. Serum Fascin1 expression quantification in plasma sample: It would be evaluated by ELISA assay.
    1. Monitoreo de la enfermedad residual mínima usando ADN circulante: Cuantificación en biopsia líquida y por PCR digital de aquellas mutaciones encontradas en tumor primario.
    2. Cuantificación en plasma de la expresión de Fascina1 sérica: Se evaluará mediante ensayo ELISA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients over 18 years.
    2. Diagnosis by biopsy.
    3. Overexpression of fascin1 in primary tumour (immunohistochemistry) as described in Conesa-Zamora et al. 2013.
    4. Resectable tumour.
    5. Ability to consent to treatment: patients or their legally authorized representative must be informed of the research nature of this study and must sign and give their informed consent in writing.
    6. Candidate adjuvant colon cancer: stage II with poor prognostic factors and stage III or
    7. Rectal cancer candidates for neo-adjuvant therapy or
    8. Non-metastatic triple negative breast cancer candidates for neo-adjuvant therapy.
    1. Pacientes mayores de 18 años.
    2. Diagnóstico por biopsia.
    3. Sobreexpresión de fascina1 en tumor primario (inmunohistoquímica) según descrito en Conesa-Zamora et al. 2013.
    4. Tumor resecable.
    5. Capacidad para dar su consentimiento para el tratamiento: los pacientes o su representante legalmente autorizado deben estar informados de la naturaleza de investigación de este estudio y deben firmar y dar su consentimiento informado por escrito.
    6. Carcinoma de colon candidato adyuvante: estadio II con factores de mal pronóstico y estadio III o
    7. Carcinoma de recto candidatos a terapia neoadyuvante o
    8. Carcinoma de mama triple negativo no metastásico candidatas a terapia neoadyuvante.
    E.4Principal exclusion criteria
    1. Metastatic disease at diagnosis or not candidates for neo-adjuvant therapy.
    2. Colorectal cancer with clinical symptoms of sub-obstruction or obstruction.
    3. Known diagnosis of major depressive disorder, bipolar depression, or psychosis.
    4. ECOG 3 or 4 (see annexes).
    5. Renal impairment defined as glomerular filtration rate <30 mL / min / 1.73 m2
    6. Hepatic insufficiency in the judgment of the clinical investigator or bilirubin> 2 mg / dl.
    7. fulfilment of the study requirements.
    8. History of heart disease (arrhythmia, conduction abnormality, congenital long QT syndrome, or prolonged QTc rhythm seen during initial electrocardiogram> 480 ms).
    9. Current use of selective serotonin or norepinephrine reuptake inhibitors (SSRIs, SNRIs), monoamine oxide inhibitors (MAOIs), tramadol or trazadone; or use of these drugs within 14 days prior to enrolment.
    1. Enfermedad metastásica al diagnóstico o no candidatos a recibir terapia neoadyuvante.
    2. Cáncer colorrectal con síntomas clínicos de sub-obstrucción u obstrucción.
    3. Diagnóstico conocido de trastorno depresivo mayor, depresión bipolar o psicosis.
    4. ECOG 3 o 4.
    5. Deterioro renal definido como Tasa de filtración glomerular < 30 mL/min/1.73 m2
    6. Insuficiencia hepática a juicio del investigador clínico o bilirrubina > 2 mg/dl.
    7. A juicio del investigador, condiciones médicas concurrentes graves no controladas, enfermedad psiquiátrica o condición social que limitarían el cumplimiento de los requisitos del estudio.
    8. Historia de enfermedad cardíaca (arritmia, anomalía de la conducción, síndrome de QT prolongado congénito o ritmo de QTc prolongado observado durante el electrocardiograma inicial > 480 ms).
    9. Uso actual de Inhibidores selectivos de la recaptación de serotonina o noradrenalina (ISRS, IRSN), inhibidores de la monoamino oxidas (IMAO), tramadol o trazadona; o uso de estos fármacos dentro de los 14 días anteriores al reclutamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the histological traits of invasive tumour front of the surgical tumour resection specimen between the intervention group and the placebo group:
    1. Fascin1 expression in tumour tissue: It will be analysed by immunohistochemistry and the application of Immunoscore.
    2. Histological manifestations of the epithelial-mesenchymal transition (EMT): Tumour budding, cytoplasmic pseudo-fragments, infiltrating growth pattern and poorly differentiated nests. It will be evaluated by histological analysis.
    3. Invasive histological manifestations: discontinuous extramural extension, lymphatic, venous and perineural infiltration. It will be evaluated by histological analysis.
    4. Histological manifestation of the immune response: Peritumoral and intratumour lymphocyte infiltration. It will be evaluated by histological analysis.
    5. EMT molecular manifestations: FSCN1, SNAIL and SLUG gene expression. It will be evaluated by NGS analysis of the primary tumour.
    Comparación de las características histológicas del frente invasor tumoral de la pieza de resección quirúrgica entre el grupo de intervención y el grupo placebo:
    1. Expresión de Fascina1 en el tejido tumoral: Se evaluará mediante inmunohistoquímica y aplicación de Immunoscore.
    2. Manifestaciones histológicas de la transición epitelio-mesénquima (EMT): Gemación tumoral, pseudo-fragmentos citoplasmáticos, patrón de crecimiento infiltrante y nidos poco diferenciados. Se evaluará mediante análisis histológico.
    3. Manifestaciones histológicas de la invasión: Extensión extramural discontinua, infiltración linfática, venosa y perineural. Se evaluará mediante análisis histológico.
    4. Manifestaciones histológicas de la respuesta inmune: Infiltrados linfocíticos peritumorales e intratumorales. Se evaluará mediante análisis histológico.
    5. Manifestaciones moleculares de la EMT: Expresión de genes FSCN1, SNAIL y SLUG. Se evaluará mediante análisis NGS del tumor primario.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Depending on type cancer:
    - Colon cancer: 2-6 weeks.
    - Rectal cancer: 15-23 weeks.
    - Triple negative breast cancer (TNBC): 20-24 weeks.
    Dependiendo del tipo de cáncer:
    - Cáncer de colon: 2-6 semanas.
    - Cáncer de recto: 15-23 semanas.
    - Cáncer de mama triple negativo (TNBC): 20-24 weeks.
    E.5.2Secondary end point(s)
    1. Monitoring of minimal residual disease using circulating DNA: It will be analysed by liquid biopsy quantification and digital PCR of those mutations found in the primary tumour.
    2. Serum Fascin1 expression quantification in plasma sample: It would be evaluated by ELISA assay.
    1. Monitoreo de la enfermedad residual mínima usando ADN circulante: Cuantificación en biopsia líquida y por PCR digital de aquellas mutaciones encontradas en tumor primario.
    2. Cuantificación en plasma de la expresión de Fascina1 sérica: Se evaluará mediante ensayo ELISA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending on type cancer:
    - Colon cancer: 2-6 weeks.
    - Rectal cancer: 15-23 weeks.
    - Triple negative breast cancer (TNBC): 20-24 weeks.
    Dependiendo del tipo de cáncer:
    - Cáncer de colon: 2-6 semanas.
    - Cáncer de recto: 15-23 semanas.
    - Cáncer de mama triple negativo (TNBC): 20-24 weeks.
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned3
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state180
    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 Decision2021-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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