Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-004323-37
    Sponsor's Protocol Code Number:BOS-IIG-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:2015-02-09
    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 number2013-004323-37
    A.3Full title of the trial
    Single nucleotide polymorphism association with response and toxic effects in patients with Ph+ CP-CML treated with bosutinib after relapse or intolerance to previous treatment.
    Estudio de correlación de polimorfismos con la respuesta y toxicidad a bosutinib en pacientes con Leucemia Mieloide Crónica (LMC) cromosoma Filadelfia positivo en fase crónica con respuesta no óptima a tratamiento previo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Single nucleotide polymorphism association with response and toxic effects in patients with Ph+ CP-CML treated with bosutinib after relapse or intolerance to previous treatment.
    Estudio de correlación de polimorfismos con la respuesta y toxicidad a bosutinib en pacientes con Leucemia Mieloide Crónica (LMC) cromosoma Filadelfia positivo en fase crónica con respuesta no óptima a tratamiento previo
    A.3.2Name or abbreviated title of the trial where available
    BOSTRO
    BOSTRO
    A.4.1Sponsor's protocol code numberBOS-IIG-01
    A.5.4Other Identifiers
    Name:GELMC-BOS-2013-02Number:GELMC-BOS-2013-02
    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 PETHEMA para el tratamiento de la leucemia y el linfoma
    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 supportPfizer, S.L.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Pethema
    B.5.2Functional name of contact pointDr. Alfonso J. Santiago Marí
    B.5.3 Address:
    B.5.3.1Street AddressHospital Clínico San Carlos. Calle Profesor Martín Lagos, s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+34609282632
    B.5.5Fax number+34913303321
    B.5.6E-mailalfonso.santiago@pethema.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 No
    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 nameBosutinib
    D.3.4Pharmaceutical form Coated 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 INNBOSUTINIB
    D.3.9.1CAS number 380843-75-4
    D.3.9.4EV Substance CodeSUB29176
    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
    Patients with chromosome Philadelphia positive (Ph+) in chronic phase mielogenus leukemia (CP CML)
    Leucemia mieloide Crónica cromosoma Filadelfia positivo en fase crónica con respuesta no óptima a tratamiento previo
    E.1.1.1Medical condition in easily understood language
    Patients with chromosome Philadelphia positive (Ph+) in chronic phase mielogenus leukemia (CP CML)
    Leucemia mieloide Crónica cromosoma Filadelfia positivo en fase crónica con respuesta no óptima a tratamiento previo
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10034877
    E.1.2Term Philadelphia chromosome positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess single nucleotide polymorphisms in genes potentially relevant for bosutinib action, metabolism and transport and if there is an association between this and the drug activity and toxicity.
    Determinar si polimorfismos de nucleótido único en genes potencialmente relevantes para el metabolismo, transporte y actividad de bosutinib se asocian con diferencias en respuesta y en toxicidad del fármaco.
    E.2.2Secondary objectives of the trial
    - Assess the eficacy and toxicity of bosutinib in patients after relapse or intolerance to previous tyrosine kinase inhibitors .
    - Assess the bosutinib eficacy reason depending on the failure of the previous treatment.
    ?Evaluar la eficacia y toxicidad del tratamiento con bosutinib en pacientes con respuesta no óptima a los 3 meses con otros inhibidores de tirosina kinasa.
    ?Analizar la eficacia de bosutinib de acuerdo a las causas por las que se alcanzó una respuesta no óptima al tratamiento previo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed and dated informed consent form.
    2.Patients with chronic phase of Ph+ CML who showed failure to previous TKI treatment. Failure is defined as BCR-ABL >10% by qRT-PCR (IS) at 3 months of treatment initiation.
    3.ECOG Performance Status of 0 or 1.
    4.Recovered to Grade 0-1, or to baseline, from any toxicities of prior treatment, other than alopecia
    5.Able to take daily oral capsules
    6.Adequate bone marrow function: a. Absolute neutrophil count > 1000/mm3 (>1000 x109/L) b. Platelets ? 100,000/mm3 (>100 x109/L) absent any platelet transfusions during the preceding 14 days.
    7.Adequate hepatic, and renal function:
    oAST/ALT ? 2.5 × upper limit of normal (ULN) or ? 5 × ULN if attributable to liver involvement of leukemia
    oTotal bilirubin ? 1.5 × ULN
    oCreatinine ? 1.5 × ULN
    8.Age > 18 years
    9.Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study and for 30 days after the last dose of Bosutinib.
    1.Consentimiento informado firmado y fechado.
    2.Pacientes con LMC Ph+ en fase crónica que hayan presentado respuesta no óptima a los 3 meses a tratamiento previo ITK (imatinib, nilotinib, dasatinib). Se define como respuesta no optima BCR-ABL >10% por qRT-PCR (IS) a los 3 meses de inicio del tratamiento.
    3.Estado funcional ECOG de 0 o 1.
    4.Recuperación a Grado 0-1, o con el valor basal de cualquier toxicidad del tratamiento previo, excepto alopecia.
    5.Capacidad para tomar cápsulas orales diariamente.
    6.Adecuada función de la médula ósea:
    ?Recuento absoluto de neutrófilos > 1.000/mm3 (>1.000 x109/L)
    ?Plaquetas ? 100.000/mm3 (>100 x109/L)
    ?Ausencia de transfusión de plaquetas durante los 14 días precedentes.
    7.Función hepática y renal adecuadas:
    ?AST/ALT ?2.5 × límite superior de normalidad (LSN). (Si la elevación se considera secundaria al tratamiento previo se podrá realizar una segunda determinación que demuestre la desaparición de esta toxicidad)
    ?Bilirrubina total ?1.5 × LSN.
    ?Creatinina ?1.5 × LSN.
    8.Edad > 18 años.
    9.La voluntad de los sujetos de ambos sexos, que no hayan sido esterilizados quirúrgicamente o estén en la postmenopausia, de usar métodos anticonceptivos fiables (anticonceptivos orales, dispositivos intrauterinos o métodos de barrera que utilizan espermicida) durante la duración del estudio y durante 30 días después de la última dosis de bosutinib.
    E.4Principal exclusion criteria
    1.Subjects with Philadelphia chromosome and bcr-abl negative CML.
    2. Overt leptomeningeal leukemia. Subjects must be free of CNS involvement for a minimum of 2 months. Subjects with symptoms of CNS involvement must have a diagnostic lumbar puncture prior to study enrollment.
    3.Subjects with extramedullary disease only.
    4.Prior stem cell transplantation.
    5.Major surgery within 14 days or radiotherapy within 7 days before the first dose of Bosutinib (recovery from any previous surgery should be complete before day 1)
    6.A history of a clinically significant ventricular arrhythmia, congenital or acquired prolonged QT interval, a baseline QTcF > 0.47 sec (average of triplicate readings) or unexplained syncope, uncontrolled or symptomatic congestive heart failure (CHF) within 3 months, or myocardial infarction (MI) within 6 months.
    7.Concomitant use of or need for medications known to prolong the QT interval
    8.Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval
    9.Recent (within 30 days of study entry) or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, short bowel syndrome, bleeding, or grade >1 diarrhea, nausea or emesis lasting more than 2 days, despite adequate medical therapy)
    10.Pregnant or breastfeeding women
    11.Evidence of serious active infection, or significant medical or psychiatric illness
    12.Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C (antigen positive), cirrhosis, hypokalemia (any grade), or clinically significant abnormal laboratory finding that would, in the investigator?s judgment, make the subject inappropriate for this study.
    1.Sujetos con LMC cromosoma Filadelfia y bcr-abl negativa.
    2.Leucemia leptomeníngea conocida. Los sujetos deben estar libres de afectación del SNC durante un mínimo de 2 meses. Los sujetos con síntomas de afectación del SNC deben tener una punción lumbar diagnóstica antes de entrar en el estudio.
    3.Sujetos con una enfermedad exclusivamente extramedular.
    4.Trasplante previo de células madre.
    5.Cirugía mayor antes de 14 días o radioterapia 7 días antes de la primera dosis de bosutinib (la recuperación de cualquier cirugía previa debe ser completa antes del día 1).
    6.Historia de arritmia ventricular clínicamente significativa, prolongación del intervalo QT congénita o adquirida, una situación basal de QTcF> 0,47 seg (promedio de las lecturas por triplicado) o síncope inexplicable, insuficiencia cardiaca congestiva sintomática (ICC) no controlada en los 3 meses previos, o infarto de miocardio (IM ) dentro de los 6 meses.
    7.Uso o necesidad de medicamentos que se sepa que prolongan el intevalo QT.
    8.Hipomagnesemia o hipopotasemia no corregida debida a los posibles efectos sobre el intervalo QT.
    9.Alteración gastrointestinal reciente (dentro de 30 días del inicio del estudio) o actual (p.e., malabsorción, síndrome del intestino corto, sangrado, diarrea de grado >1, náusea o émesis de más de dos días de duración, a pesar de adecuada terapia médica.
    10.Mujeres embarazadas o en lactancia.
    11.Evidencia de infección activa seria, o enfermedad médica o psiquátrica importante.
    12.Seropositividad para el VIH (Virus de la Inmunodeficiencia Humana), o hepatitis B o C (antígeno positiva) aguda o crónica actuales, cirrosis, hipopotasemia (cualquier grado), o cualquier hallazgo de laboratorio clínicamente significativo que pueda, a juicio del investigador, hacer inapropiado al sujeto para el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Assess single nucleotide polymorphisms in genes potentially relevant for bosutinib action, metabolism and transport and if there is an association between this and the drug activity and toxicity.
    Determinar si polimorfismos de nucleótido único en genes potencialmente relevantes para el metabolismo, transporte y actividad de bosutinib se asocian con diferencias en respuesta y en toxicidad del fármaco
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment
    Fin de tratamiento
    E.5.2Secondary end point(s)
    - Assess the eficacy and toxicity of bosutinib in patients after relapse or intolerance to previous tyrosine kinase inhibitors .
    - Assess the bosutinib eficacy reason depending on the failure of the previous treatment.
    ?Evaluar la eficacia y toxicidad del tratamiento con bosutinib en pacientes con respuesta no óptima a los 3 meses con otros inhibidores de tirosina kinasa.
    ?Analizar la eficacia de bosutinib de acuerdo a las causas por las que se alcanzó una respuesta no óptima al tratamiento previo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of treatment
    Fin de tratamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 No
    E.8.1.1Randomised No
    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.8.3 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 concerned13
    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
    Overall survival, progression and other treatments.
    Supervivencia global, progresión e inicio de otro tratamiento
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 50
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    Clinical Practice
    Práctica Clínica Habitual
    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 Decision2015-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-28
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA