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    Summary
    EudraCT Number:2013-001203-36
    Sponsor's Protocol Code Number:CI-IPOP.22-2012
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-12-13
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2013-001203-36
    A.3Full title of the trial
    Phase II trial of the addition of Lapatinib to Capecitabine versus Capecitabine alone as radio-sensitizers in KRAS wild type resectable
    rectal cancer
    Ensaio de Fase II que estuda a adição de Lapatinib a Capecitabina comparado com Capecitabina como radiossensibilizadores em
    doentes com cancro do reto ressecável, sem
    mutações do gene KRAS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess wether Lapatinib in association with Capecitabine and Radiation performs better than Capecitabine and Radiation in patients with localized rectal cancer
    Ensaio clínico para avaliar se a associação de Lapatinib com Capecitabina e Radioterapia é melhor do que Capecitabina e Radioterapia em doentes com cancro do recto localizado
    A.3.2Name or abbreviated title of the trial where available
    LaRRC Trial
    Ensaio LaRRC
    A.4.1Sponsor's protocol code numberCI-IPOP.22-2012
    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 Português de Oncologia do Porto Francisco Gentil, EPE
    B.1.3.4CountryPortugal
    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 supportGlaxoSmithKline
    B.4.2CountryPortugal
    B.4.1Name of organisation providing supportIPO Porto FG, EPE
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Português de Oncologia do Porto Francisco Gentil, EPE
    B.5.2Functional name of contact pointUnidade de Investigação Clínica
    B.5.3 Address:
    B.5.3.1Street AddressRua Dr. António Bernardino de Almeida
    B.5.3.2Town/ cityPorto
    B.5.3.3Post code4200-072
    B.5.3.4CountryPortugal
    B.5.4Telephone number351225084000
    B.5.5Fax number351225084008
    B.5.6E-mailclinicalstudies@ipoporto.min-saude.pt
    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 Tyverb
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited, Greenford - Middlesex, Reino Unido
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated tablet
    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
    Rectal cancer stage II
    Rectal cancer stage III
    Cancro do Reto, estádio II
    Cancro do Reto, estádio III
    E.1.1.1Medical condition in easily understood language
    Rectal Cancer
    Cancro do Reto
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10038050
    E.1.2Term Rectal 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 16.1
    E.1.2Level PT
    E.1.2Classification code 10038049
    E.1.2Term Rectal cancer stage II
    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
    The trial’s objective is to show the superiority of Lapatinib and Capecitabine combination (arm A) over the standard Capecitabine (arm B)
    O objectivo do estudo é demonstrar a superioridade da combinação Lapatinib e Capecitabina (braço A) sobre o padrão, Capecitabina (braço B).
    E.2.2Secondary objectives of the trial
    Not Applicable
    Não Aplicável
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or above.
    2. Diagnosis of adenocarcinoma of the rectum with the primary malignant lesion located between the dentate line up to 10cm of the anal verge by endoscopic examination.
    3. KRAS mutational analysis of codon 12 and 13 without known activating mutations.
    4. Clinical Stage II or III disease, according to AJCC Staging classification, 7th edition. For clinical staging the following procedures must have been conducted, within 4 weeks of treatment allocation:
    4.1. Clinical History and Physical Examination,
    4.2. Endoscopic ultrasound of the primary lesion,
    4.3. Thoracic, abdominal and pelvic computed tomographic scan.
    5. Clinically judged to be able to undergo curative resection of the rectal neoplasm despite pre-operative chemoradiotherapy.
    6. Clinically judged to be able to undergo pelvic radiation therapy to a total dose of 50.4 Gy.
    7. Signed informed consent.
    1. Idade igual ou superior a 18 anos.
    2. Diagnóstico de adenocarcinoma do reto com o tumor maligno primário localizado, por exame endoscópico, entre a linha denteada e até 10 centímetros da margem anal.
    3. Estudo do codão 12 e 13 gene KRAS, sem mutações ativadoras conhecidas.
    4. Doença em estádio clínico II ou III, segundo a classificação de Estádio da AJCC, 7 ª edição. Para o estadiamento clínico os seguintes procedimentos devem ter sido realizados, até 4 semanas antes da alocação terapêutica:
    4.1. História clínica e exame físico,
    4.2. Ecoendoscopia da lesão primária,
    4.3. Tomografia Computadorizada do tórax, abdómen e pélvis.
    5. Juízo clínico de que a doença é passível de ser ressecada com intenção curativa apesar da realização de quimiorradioterapia pré-operatória.
    6. Juízo clínico de que é capaz de tolerar um tratamento de radioterapia externa à pélvis com uma dose total de 50,4 Gy.
    7. Consentimento informado explícito para participar no ensaio.
    E.4Principal exclusion criteria
    1. Absence of baseline histological sample of the primary tumor.
    2. Pregnant or lactating women.
    3. Unwillingness or inability to comply with effective contraception, if the patient is fertile.
    4. Impaired renal function defined as creatinine clearance < 60mL/min according to the Cockcroft-Gault formula.
    5. Impaired hematological function: defined by any of the following on pre-treatment evaluation:
    5.1. Hemoglobin concentration < 10.0 g/dL,
    5.2. Absolute neutrophile count < 1 500 µL-1 and
    5.3. Platelet count < 100 000 µL-1.
    6. Impaired hepatic function defined by any of the following on pre-treatment evaluation:
    6.1. Serum level of aspartate aminotransferase > 1.5 x ULN,
    6.2. Serum level of alanine aminotransferase > 1.5 x ULN,
    6.3. Serum level of alkaline phosphatase > 1.5 x ULN,
    6.4. International Normalized Ratio > 1.5 and
    6.5. Serum concentration of total bilirrubin > 1.5 x ULN.
    7. Symptomatic heart failure or a left ventricular ejection fraction below the institution’s lower limit of normality as assessed through equilibrium radionuclide angiography.
    8. Known intolerance to any of the study drugs.
    9. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
    10. Concurrent treatment with CYP3A4 inducers.
    11. Concurrent treatment with CYP3A4 inhibitors.
    12. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel.
    13. Currently enrolled in another clinical trial.
    1. Ausência de amostra histológica do tumor primário antes da aleatorização.
    2. Mulheres grávidas ou a amamentar.
    3. Se o doente é fértil, falta de vontade ou incapacidade de cumprir com um plano de contracepção eficaz.
    4. Disfunção renal definida como uma taxa de depuração de creatinina <60mL/min de acordo com a fórmula de Cockcroft-Gault.
    5. Alteração hematológica definida por qualquer uma das seguintes alterações na avaliação pré-tratamento:
    5.1. Concentração de hemoglobina <10,0g/dL,
    5.2. Contagem absoluta de neutrófilos <1 500µL-1 ou
    5.3. Contagem de plaquetas <100 000µL-1.
    6. Alteração da função hepática definida por qualquer uma dos seguintes alterações na avaliação de pré-tratamento:
    6.1. Níveis séricos de aspartato aminotransferase> 1,5 x LSN,
    6.2. Níveis séricos de alanina aminotransferase> 1,5 x LSN,
    6.3. Nível sérico de fosfatase alcalina> 1,5 x LSN,
    6.4. Razão Normalizada Internacional> 1,5 ou
    6.5. Concentração sérica de bilirrubina total> 1,5 x LSN.
    7. Insuficiência cardíaca sintomática ou fração de ejeção ventricular esquerda abaixo do limite inferior da normalidade da instituição, avaliada através de angiografia por radionuclídeos em equilíbrio.
    8. Intolerância a qualquer um dos medicamentos do estudo.
    9. Deficiência da desidrogenase das dihidropirimidina (DPD).
    10. Tratamento concomitante com indutores do CYP3A4.
    11. Tratamento concomitante com inibidores do CYP3A4.
    12. Incapacidade, ou percepção de ser incapaz, de cumprir o protocolo ou de cooperar completamente com o investigador ou com a equipa do estudo.
    13. Estar incluído noutro ensaio terapêutico.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is pathologic complete remission.
    A medida de resultado primária é resposta patológica completa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgical treatment.
    Após tratamento cirúrgico.
    E.5.2Secondary end point(s)
    Safety profile of the combination Lapatinib / Capecitabine / Radiation therapy in the pre-operative setting of patients with resectable rectal cancer.
    Perfil de segurança da combinação Lapatinib / Capecitabina / Radioterapia Externa na abordagem terapêutica pré-operatória de doentes com cancro do reto ressecável.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through-out the length of the trial until the end of study, 28 days after surgery.
    Contínuo durante o tratamento e até 28 dias após a cirurgia.
    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 Yes
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Desenho com aleatorização adaptativa Bayesiana
    Adpative Bayesian Randomization Design
    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 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
    Thirty days after the last subject last visit.
    To allow for the identification of delayed side effects of Surgical Treatment.
    Trinta dias após a última visita do último sujeito do ensaio.
    Para permitir a identificação de efeitos retardados do tratamento cirúrgico.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 80
    F.1.3Elderly (>=65 years) No
    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 state80
    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
    Nenhuma provisão.
    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 Decision2014-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-07
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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