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    Summary
    EudraCT Number:2017-004350-42
    Sponsor's Protocol Code Number:SRA-MMB-4365
    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:2018-06-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-004350-42
    A.3Full title of the trial
    Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential
    Thrombocythemia Myelofibrosis (Post-PV/ET MF)
    Acceso ampliado a momelotinib para pacientes con mielofibrosis primaria (MFP) o mielofibrosis post-policitemia vera o post-trombocitemia esencial (MF post-PV/TE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extended Access of Momelotinib for Subjects with Myelofibrosis
    Acceso ampliado a momelotinib para pacientes con mielofibrosis
    A.4.1Sponsor's protocol code numberSRA-MMB-4365
    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 SponsorSierra Oncology, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSierra Oncology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSierra Oncology, Inc.
    B.5.2Functional name of contact pointMartha Bond
    B.5.3 Address:
    B.5.3.1Street Address46701 Commerce Center Drive
    B.5.3.2Town/ cityPlymouth, MI
    B.5.3.3Post code48170
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1416528 7431
    B.5.6E-mailmbond@sierraoncology.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/11/888, EU/3/11/887 and EU/3/11/886
    D.3 Description of the IMP
    D.3.1Product nameMomelotinib
    D.3.2Product code SRA-0387
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmomelotinib
    D.3.9.3Other descriptive nameMOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB126831
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/11/888, EU/3/11/887 and EU/3/11/886
    D.3 Description of the IMP
    D.3.1Product nameMomelotinib
    D.3.2Product code SRA-0387
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmomelotinib
    D.3.9.3Other descriptive nameMOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB126831
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/11/888, EU/3/11/887 and EU/3/11/886
    D.3 Description of the IMP
    D.3.1Product nameMomelotinib
    D.3.2Product code SRA-0387
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmomelotinib
    D.3.9.3Other descriptive nameMOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB126831
    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
    Primary Myelofibrosis (PMF), Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
    Mielofibrosis Primaria (MFP) o Mielofibrosis Post-policitemia Vera o Post-trombocitemia esencial (MF post-PV/TE)
    E.1.1.1Medical condition in easily understood language
    Blood disorder that means the body produces too many mature blood cells too quickly.
    Trastorno de la sangre que significa que el cuerpo produce demasiadas células sanguíneas maduras demasiado deprisa.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028537
    E.1.2Term Myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To provide extended access to momelotinib in 3 cohorts of subjects who are currently receiving treatment with MMB and have not experienced progression of disease:
    - Cohort 1: Study GS-US-352-0101, subjects with PMF or post-PV/ET MF
    - Cohort 2: Study GS-US-352-1214, subjects with PMF or post-PV/ET MF
    - Cohort 3: Study GS-US-352-1154, subjects with PMF or post-PV/ET MF
    El objetivo principal de este estudio es proporcionar acceso ampliado a momelotinib en 3 cohortes de pacientes que reciben actualmente tratamiento con MMB y no han experimentado progresión de la enfermedad:
    - Cohorte 1: estudio GS-US-352-0101, pacientes con MFP o MF post-PV/TE.
    - Cohorte 2: estudio GS-US-352-1214, pacientes con MFP o MF post-PV/TE
    - Cohorte 3: estudio GS-US-352-1154, pacientes con MFP o MF post-PV/TE
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154
    2) Did not discontinue treatment with MMB for any reason while enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154
    3) Any Grade 3 or 4 (CTCAE Version 4.03) non-hematologic toxicity in the prior study that the investigator considers related to previous MMB use must have resolved, reverted to Grade 1, or reverted to baseline within the 30 days from last MMB administration to Day 1 of this study
    4) Any AE requiring MMB interruption during the prior study must have resolved, reverted to Grade 1, or reverted to baseline within the 30 days from last MMB administration to Day 1 of this study
    1)Incluido actualmente en los estudios GS-US-352-0101, GS-US-352-1214 o GS-US-352-1154.
    2)No interrumpió el tratamiento con MMB por ningún motivo mientras participaba en los estudios GS-US-352-0101, GS-US-352-1214 o GS-US-352-1154.
    3) Cualquier toxicidad no hematológica de grado 3 o 4 (Criterios terminológicos comunes para acontecimientos adversos [Common Terminology Criteria for Adverse Events, CTCAE], versión 4.03) en el estudio anterior, que el investigador considere relacionada con el uso previo de MMB, debe haberse resuelto, haber vuelto al grado 1 o vuelto al valor inicial en el plazo de 30 días desde la última administración de MMB hasta el día 1 de este estudio.
    4) Cualquier acontecimiento adverso (AA) que requiera la interrupción de MMB durante el estudio anterior debe haberse resuelto, haber vuelto al grado 1 o vuelto al valor inicial en el plazo de 30 días desde la última administración de MMB hasta el día 1 de este estudio.
    E.4Principal exclusion criteria
    1) Known hypersensitivity to MMB, its metabolites, or formulation excipient
    2) Incomplete recovery from major surgery prior to Day 1 of this study
    3) Presence of ≥ Grade 3 (CTCAE Version 4.03) peripheral neuropathy
    1) Hipersensibilidad conocida a MMB, sus metabolitos o los excipientes de la formulación.
    2) Recuperación incompleta de una cirugía mayor antes del día 1 de este estudio.
    3) Presencia de neuropatía periférica de grado ≥3 (CTCAE, versión 4.03).
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of AEs, as defined by CTCAE Version 4.03
    Incidencia y severidad de AAs, tal y como se define en CTCAE Version 4.03
    E.5.1.1Timepoint(s) of evaluation of this end point
    From patient enrollment to Week 96 or Early Study Drug Discontinuation visit plus 30 days
    Desde la inclusión del paciente hasta la Semana 96 o hasta la Visita de Discontinuación temprana de Fármaco del estudio más 30 días.
    E.5.2Secondary end point(s)
    Not Applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    No aplica
    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 No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Romania
    Singapore
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    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. End of study for a subject is after the subject has completed their Week 96 or ESDD visit plus 30 days of follow-up or date of 30 June 2020, whichever occur first.
    UVUP. El fin del estudio para un paciente es después de que el paciente haya completado su Semana 96 o la Visita de DTFE más 30 días.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 82
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 118
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 136
    F.4.2.2In the whole clinical trial 200
    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)
    After the patients have completed/terminated their study participation, long term care for the patient will remain the responsibility of their primary treating physician
    Después de que los pacientes hayan completado/terminado su participación en el estudio, el cuidado a largo plazo del paciente será responsabilidad del médico que inicialmente le trataba.
    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 Decision2018-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-16
    P. End of Trial
    P.End of Trial StatusOngoing
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