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    Summary
    EudraCT Number:2014-000898-39
    Sponsor's Protocol Code Number:SSGXXII
    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:2015-10-15
    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 number2014-000898-39
    A.3Full title of the trial
    Three versus five years of adjuvant imatinib as treatment of patients with operable GIST with a high risk for recurrence: A randomised phase III study.
    Estudio fase III randomizado en el que se compara el tratamiento con imatinib adyuvante durante 3 años frente a 5 años para pacientes con GIST operable con alto riesgo de recurrencia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study that compares GIST patients that have completed 3 years with imatinib treatment with patients that keep on 2 more years with the same treatment to determine if the risk of the recurring tumor reduces.
    Estudio que compara a pacientes con GIST que han completado 3 años de tratamiento con imatinib con pacientes que continúan durante otros 2 años más en tratamiento para comprobar si disminuye el riesgo de que vuelva a aparecer el tumor.
    A.4.1Sponsor's protocol code numberSSGXXII
    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 SponsorScandinavian Sarcoma Group
    B.1.3.4CountrySweden
    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 supportNovartis Pharma
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScandinavian Sarcoma Group
    B.5.2Functional name of contact pointSSG secretariat
    B.5.3 Address:
    B.5.3.1Street AddressScheelevägen 8
    B.5.3.2Town/ cityLund
    B.5.3.3Post codeSE-223 81
    B.5.3.4CountrySweden
    B.5.4Telephone number4646275 21 82
    B.5.5Fax number4646188 143
    B.5.6E-mailssg@med.lu.se
    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 Glivec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 Tablet
    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 INNimatinib (como mesilato)
    D.3.9.1CAS number 152459-95-5
    D.3.9.3Other descriptive nameIMATINIB
    D.3.9.4EV Substance CodeSUB25387
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    gastrointestinal stromal tumor (GIST)
    Tumor del estroma gastrointestinal
    E.1.1.1Medical condition in easily understood language
    Gastrointestinal stromal tumor (GIST) is a rare cancer affecting the digestive tract or nearby structures within the abdomen.
    Tumor del estroma gastrointestinal es un cancer raro que afecta el tracto digestivo y otras estructuras adyacentes en el abdomen
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Calculate the recurrence-free survival (RFS) after randomisation
    Calcular la Supervivencia Libre de Recurrencia tras la aleatorización
    E.2.2Secondary objectives of the trial
    1. Calculate the overall survival
    2. Calculate the GIST-specific survival
    3. Assess the toxicity in patients treated with imatinib
    4. Assess the Quality of life in patients treated with imatinib
    1. Calcular la supervivencia global
    2. Calcular la supervivencia de pacientes con GIST
    3. Evaluar la toxicidad en pacientes tratados con Imatinib
    4. Evaluar la calidad de vida en pacientes tratados con imatinib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ? 18 years.
    2. Morphological and immunohistological documentation of GIST (immunostaining for KIT [CD117] and/or DOG-1 positive, or mutation of KIT or PDGFRA present in tumour tissue).
    3. Macroscopically complete surgical resection of GIST (either R0 or R1 resection).
    4. Mutation analysis of KIT and PDGFR genes has been carried out.
    5. A high risk of GIST recurrence, either
    1) gastric GIST with mitotic count >10/50 HPFs, or
    2) non-gastric GIST with mitotic count >5/50 HPFs, or
    3) tumour rupture
    Tumour rupture (spillage of the tumour contents into the abdominal cavity) may have occurred either before or at surgery.
    6. ECOG performance status ? 2.
    7. Adequate organ function, defined as
    serum total bilirubin <1.5 x ULN (upper limit of normal), serum AST (SGOT) and ALT (SGPT) <2.5 x ULN, creatinine <1.5 x ULN; blood ANC (neutrophil count) ?1.0 x 109/L, platelet count ?100 x 109/L.
    8. Female patients of childbearing potential must have a negative pregnancy test within 14 days before initiation of study drug dosing. Postmenopausal women must have amenorrhoea for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
    9. Patient willing to be followed up at the study site regardless of the result of randomisation.
    10. Patient has provided a written, voluntary informed consent prior to study-specific screening procedures.
    1. Edad ? 18 años
    2. Documentación morfológica y immunohistológica de GIST (inmunotinción para KIT (CD117) y/o DOG-1 positivo, o mutación presente en KIT o PDGFRA en el tejido tumoral
    3. Resección quirúrgica macroscópicamente completa de GIST (resección R0 o R1)
    4. Análisis mutacional de KIT y PDGFR
    5. Alto riesgo de recurrencia de GIST por:
    a)GIST gástrico con indice mitótico>10/50 HPFs, o
    b)GIST no gástrico con índice mitótico> 5/50 HPFs, o
    c) Ruptura del tumor
    La ruptura del tumor (derrame del contenido tumoral en la cavidad abdominal) puede haber ocurrido antes o durante la cirugía.
    6. ECOG ? 2
    7. Funciones orgánicas adecuadas, definidas como :
    bilirrubina total <1.5 x ULN (upper limit of normal), AST (SGOT) y ALT (SGPT) <2.5 x ULN, creatinina <1.5 x ULN; recuento de neutrófilos ?1.0 x 109/L,recuento de plaquetas ?100 x 109/L.
    8. Mujeres en edad fertil han de tener un resultado negativo en un test de embarazo realizado en los 14 días previos a iniciar el tratamiento del estudio. Mujeres postmenopausicas han debido tener amenorrea durante al menos 12 meses para poder ser consideradas no fértil. Hombres y mujeres en edad fértil deben acordar utilizar metodos contraceptivos durante el estudio y hasta 3 meses desde la discontinuación con el tratamiento del estudo.
    9. Los pacientes deben estar de acuerdo a que se les realice un seguimiento en el centro independientemente del resultado de la aleatorización.
    10. Paciente debe firmar de manera voluntaria el consentimiento informado antes de que se realice ninguna prueba especifica del estudio.
    E.4Principal exclusion criteria
    1. Presence of distant metastases or local recurrence of GIST.
    2. Not willing to donate tumour tissue and/or blood samples for the study molecular studies.
    3. Presence of a substitution mutation at PDGFRA codon D842 (usually D842V).
    4. Administration of adjuvant imatinib longer than for 3 years is planned regardless of the result of randomisation, or ?life long? imatinib administration is planned.
    5. Prior adjuvant (+ neoadjuvant) therapy with imatinib mesylate for at least 35 months has not been completed, or the total duration of prior adjuvant (+ neoadjuvant) imatinib administration exceeds the total duration of 37 months.
    6. Neoadjuvant imatinib for a duration that exceeds 9 months.
    7. Longer than 4-week break during adjuvant imatinib administration.
    8. The dose of imatinib at completion of 3 years of adjuvant imatinib was 200 mg per day or less or greater than 800 mg per day.
    9. Patient has received any investigational anti-cancer agents during adjuvant imatinib or between completion of adjuvant imatinib and the date of randomisation.
    10. Patient has been free of another malignancy for less than 5 years except if the other malignancy is not currently clinically significant nor requiring active intervention, or if the other malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Recent existence of any other malignant disease is not allowed.
    11. Patient with Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study entry).
    12. Female patients who are pregnant or breast-feeding.
    13. Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, severe chronic renal disease, or active uncontrolled infection).
    14. Known diagnosis of human immunodeficiency virus (HIV) infection.
    15. Patient with a significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
    1. Presencia de metastasis a distancia o recaida local de GIST
    2. El paciente no desea donar tejido tumoral o muestras de sangre para estudios moleculares.
    3. Presencia de mutación de sustitución en el codon D842 de PDGFRA (normalmente D842V).
    4. Se ha planeado la administración de imatinib en adyuvancia durante más de 3 años independientemente del resultado de la aleatorización, o se planea administrar imatinib durante la vida del paciente.
    5. No se ha completado la terapia adyuvante (+ neoadyuvante) con mesilato de imatinib durante al menos 35 meses, o la duración total del tratamiento con imatinib en adyuvancia (+ neoadyuvancia) ha superado los 37 meses de duración.
    6. Tratamiento con imatinib en neoadyuvancia durante más de 9 meses.
    7. Interrupción del tratamiento con imatinib en adyuvancia durante más de 4 semanas.
    8. La dosis de imatinib al completar los 3 años de tratamiento en adyuvancia sea de 200mg al día o menos, o mayor de 800mg al día.
    9. El paciente ha recibido ha sido tratado con otros medicamentos en investigación durante la adyuvancia con imatinib o en el tiempo entre la finalización del trtamiento con imatinib y la fecha de aleatorización.
    10. El paciente ha tenido otro cancer en menos de 5 años, a no ser que no sea significativo o no requiera ningun tipo de intervención, o si es un cancer de piel basocelular o un carcinoma de cervix in situ. Existencia reciente de otro cancer no está permitido.
    11. Pacientes con grado III/IV de enfermedad cardiaca definida por New York Hear Association Criteria (por ejemplo, insuficiencia cardiaca congestiva o infarto de miocardio en los 6 meses previos a la inclusión en el estudio)
    12. Mujeres embarazadas o en periodo de lactancia.
    13. Cualquier otra enfermedad grave y/o no controlada (por ejemplo: diabetes, enfermedad renal crónica o infección activa).
    14. Diagnóstico de infección por Virus de Inmunodeficiencia humano (VIH)
    15. Pacientes con un historial de incumplimiento terapeútico, o que no pueda otorgar su consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Recurrence-free survival (RFS)
    Supervivencia Libre de Recaida (SLR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Defined by the time interval between the date of randomisation and the date of first detection of GIST recurrence or death, whichever occurs first. CT/MRI at 6-month intervals during the first 5 years on study in each arm, and then annually.
    Se define por el intervalo de tiempo desde la fecha de aletorización hasta la fecha del diagnóstico de recaída de GIST o muerte, la que ocurra primero. Se realizarán pruebas de imágenes (TAC o RM) cada 6 meses durante los 5 primeros años en cada brazo del estudio, y posteriormente de manera anual.
    E.5.2Secondary end point(s)
    1. Overall survival
    2. GIST-specific survival
    3. Safety
    4. Quality of Life
    1. Supervivencia Global
    2. Supervivencia al GIST
    3. Seguridad
    4.Calidad de Vida
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. The time period between the date of randomisation and the date of death.
    2. The time period between the date of randomisation and the date of death considered to be caused by GIST; patients who die from other causes are censored on the date of death.
    3. Common Terminology Criteria for Adverse Events [CTCAE] version 3.0 collected every 3 months from randomisation
    4. Quality of Life (EQ-5D instrument) collected every 3 months from randomisation
    1. Periodo entre la fecha de aleatorización y la fecha de muerte.
    2. Periodo entre la fecha de aleatorización y la fecha de la muerte causada por GIST; los pacientes que fallezcan de otras causas estarán censurados en la fecha de fallecimiento.
    3. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, que se recogerán cada 3 meses desde la aleatorización.
    4. Cuestionarios de calidad de vida (EQ-5D) cada 3 meses desde la aleatorización.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    No specific plans after the end of study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Scandinavian Sarcoma Group
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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