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    Summary
    EudraCT Number:2019-000583-18
    Sponsor's Protocol Code Number:SRA-MMB-301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-12-02
    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 number2019-000583-18
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy
    Estudio en fase III aleatorizado y doble ciego para evaluar la actividad de momelotinib (MMB) frente a danazol (DAN) en pacientes anémicos sintomáticos con mielofibrosis primaria (MFP), mielofibrosis post-policitemia vera (PV) o mielofibrosis post-trombocitemia esencial (TE) tratados anteriormente con inhibidores de la Janus quinasa (JAK).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate the activity of Momelotinib versus Danazol in Anemic subjects with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis who had recevied JAK Inhibitor Therapy
    Evaluar la actividad de momelotinib frente a danazol en pacientes anémicos con mielofibrosis primaria, mielofibrosis post-policitemia vera, o mielofibrosis post-trombocitemia esencial quienes hayan recibido la terapia de inhibidores de la Janus quinasa
    A.4.1Sponsor's protocol code numberSRA-MMB-301
    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 pointAshwin Swami
    B.5.3 Address:
    B.5.3.1Street Address46701 Commerce Center Drive
    B.5.3.2Town/ cityPlymouth
    B.5.3.3Post codeMI 48170
    B.5.3.4CountryUnited States
    B.5.6E-mailaswami@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.3.4Pharmaceutical 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 CodeSUB177206
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.3.4Pharmaceutical 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 CodeSUB177206
    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.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.3.4Pharmaceutical 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 CodeSUB177206
    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: 4
    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.3.4Pharmaceutical 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 CodeSUB177206
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Danazol
    D.2.1.1.2Name of the Marketing Authorisation holderGenerics (UK) Ltd t/a Mylan
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDanazol
    D.3.4Pharmaceutical form Capsule
    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 INNDANAZOL
    D.3.9.1CAS number 17230-88-5
    D.3.9.4EV Substance CodeSUB06897MIG
    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.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 Danazol
    D.2.1.1.2Name of the Marketing Authorisation holderGenerics (UK) Ltd t/a Mylan
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDanazol
    D.3.4Pharmaceutical form Capsule
    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 INNDANAZOL
    D.3.9.1CAS number 17230-88-5
    D.3.9.4EV Substance CodeSUB06897MIG
    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: 7
    D.1.2 and D.1.3IMP RoleComparator
    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 Danazol
    D.2.1.1.2Name of the Marketing Authorisation holderLannett Company, Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameDanazol
    D.3.4Pharmaceutical form Capsule
    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 INNDANAZOL
    D.3.9.1CAS number 17230-88-5
    D.3.9.4EV Substance CodeSUB06897MIG
    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.IMP: 8
    D.1.2 and D.1.3IMP RoleComparator
    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 Danazol
    D.2.1.1.2Name of the Marketing Authorisation holderLannett Company, Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameDanazol
    D.3.4Pharmaceutical form Capsule
    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 INNDANAZOL
    D.3.9.1CAS number 17230-88-5
    D.3.9.4EV Substance CodeSUB06897MIG
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis
    Mielofibrosis primaria (MFP), mielofibrosis post-policitemia vera (PV), o mielofibrosis post-trombocitemia esencial (TE)
    E.1.1.1Medical condition in easily understood language
    A blood disorder that causes fibre in bone marrow due to producing too many mature blood cells too quickly.
    Un trastorno sanguíneo que causa fibra en la medula ósea debido a que produce demasiadas células sanguíneas maduras demasiado rápido.
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028538
    E.1.2Term Myelofibrosis with myelometaplasia
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074689
    E.1.2Term Post polycythemia vera myelofibrosis
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074690
    E.1.2Term Post essential thrombocythemia myelofibrosis
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10074691
    E.1.2Term Post polycythaemia vera myelofibrosis
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074692
    E.1.2Term Post essential thrombocythaemia myelofibrosis
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10077161
    E.1.2Term Primary 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 determine the efficacy of MMB versus DAN assessed by improvement in Myelofibrosis Symptom Assessment Form v4.0 (MFSAF) total symptom score (TSS) in subjects with PMF, post-PV myelofibrosis (MF), or post-ET MF who were previously treated with approved JAK inhibitor therapy
    Determinar la eficacia de MMB frente a DAN evaluada mediante la mejora en la puntuación total de los síntomas (PTS) del formulario de evaluación de síntomas de mielofibrosis v4.0 (Myelofibrosis Symptom Assessment Form, MFSAF) en pacientes con MFP, mielofibrosis (MF) postPV o MFpostTE que recibieron tratamiento previo con inhibidores de JAK autorizados
    E.2.2Secondary objectives of the trial
    • To compare the effect of MMB versus DAN on transfusion independent (TI) status at Week 24
    • To compare SRR for subjects treated with MMB versus DAN
    • To compare RBC transfusion requirements in subjects treated with MMB versus DAN
    • To assess the duration of MFSAF TSS response
    • To assess duration of TI status at Week 24
    • To compare the benefit of MMB versus DAN on anemia response and transfusion requirements
    • To compare change from baseline MFSAF TSS at Week 24 in subjects treated with MMB versus DAN
    • To characterize the safety of MMB
    • To compare the overall survival (OS) and leukemia-free survival (LFS) of subjects treated with MMB versus DAN
    • To compare patient-reported fatigue and physical function for MMB versus DAN
    • To compare patient-reported health status and health-related QoL for MMB versus DAN
    • To assess association of MMB exposure (pharmacokinetics [PK]) with outcome
    •Comparar el efecto de MMB frente a DAN en el estado independiente de las transfusiones en la semana 24•Comparar la TRE de los sujetos tratados con MMB frente a DAN•Comparar la necesidad de transfusiones de eritrocitos de los sujetos tratados con MMB frente a DAN•Evaluar la duración de la respuesta de PTS del MFSAF•Evaluar la duración del estado IT en la semana 24•Comparar el beneficio de MMB frente a DAN en la respuesta de anemia y la necesidad de transfusiones•Comparar el cambio desde el inicio en la PTS de MFSAF en la semana 24 en los sujetos tratados con MMB frente a DAN•Caracterizar la seguridad de MMB•Comparar la supervivencia general y la supervivencia sin leucemia de los sujetos tratados con MMB frente a DAN•Comparar la fatiga notificada por el paciente y la función física con MMB frente a DAN•Comparar el estado de salud notificado por el paciente y CdV relacionada con la salud con MMB frente a DAN
    •Evaluar la relación de la exposición a MMB (farmacocinética) con el resultado
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV/ET MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria
    3. Symptomatic, defined as a MFSAF TSS of ≥ 10 units assessed by a single MFSAF v4.0 assessment at Screening visit
    4. Anemic, defined as any of the following:
    − For any subject; having received a transfusion within 28 days prior to the first day of Baseline assessments (BL1), with pre-transfusion Hgb < 10 g/dL, or
    − For subjects without ongoing JAK inhibitor therapy at Screening; Hgb < 10 g/dL during the Baseline Period (Days BL1 to Day BL7), or
    − For subjects receiving ongoing JAK inhibitor therapy at Screening; Hgb < 10 g/dL during Screening, prior to beginning of JAK inhibitor taper
    5. Previously treated, with an approved JAK inhibitor for PMF or Post-PV/ET MF for ≥ 90 days, or ≥ 28 days if JAK inhibitor therapy is complicated by RBC transfusion requirement of ≥ 4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma
    − Subjects who discontinued JAK inhibitor therapy prior to Screening require no additional non-treatment interval
    − For subjects with ongoing JAK inhibitor therapy at Screening, JAK inhibitor therapy must be tapered over a period of at least 1 week, and a non-treatment interval begin 7 days prior to Day BL1 (the first of 7 consecutive days of baseline MFSAF assessments)
    6. Baseline splenomegaly, defined as having a palpable spleen at ≥ 5 cm, below the LCM, or with volume ≥ 450 cm3 on imaging (ultrasound, MRI or CT are acceptable), assessed during Screening at any point prior to Randomization
    7. High risk, intermediate-2, or intermediate-1 risk as defined by DIPSS, or DIPSS-plus
    8. No allogeneic stem cell transplant planned
    9. Acceptable laboratory assessments:
    - ANC ≥ 0.75 x 10(9)/L
    - PLT ≥ 25 x 10(9)/L
    - Peripheral blast count < 10%
    - AST/SGOT and ALT/SGPT ≤ 3 x ULN
    - Calculated creatinine clearance ≥ 30 mL/min
    - Direct bilirubin ≤ 2.0 x ULN
    10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    11. Life expectancy > 24 weeks
    12. Able to understand and willing to sign the ICF
    13. Willing and able to complete PRO assessments using an ePRO device according to protocol
    14. WOCBP, men with partners of childbearing potential, and subjects with pregnant or lactating partners must agree to follow the contraceptive requirements of the clinical trial protocol, effective from the first administration of MMB, throughout the trial and for 6 months after the last dose of MMB.
    1. Edad ≥18 años
    2. Diagnóstico confirmado de MFP, de acuerdo con los criterios de 2016 de la Organización Mundial de la Salud (OMS) o MF post-PV/PTE de acuerdo con los criterios del Grupo de trabajo internacional de investigación y tratamiento de las neoplasias mieloproliferativas (International Working Group-Myeloproliferative Neoplasms Research and Treatment, IWG-MRT)
    3. Sintomáticos, definido como una PTS de MFSAF ≥10 unidades evaluada mediante una sola evaluación de MFSAF v4.0 en la visita de selección
    4. Con anemia, que se define como cualquiera de los siguientes:
    - Para cualquier sujeto; haber recibido una transfusión en el plazo de 28 días antes del primer día de las evaluaciones iniciales (I1), con Hgb previa a la transfusión <10 g/dl, o
    - Para los pacientes sin tratamiento inhibidor de la JAK en curso en la selección; Hgb <10 g/dl durante el período inicial (día I1 a I7), o
    - Para los sujetos en tratamiento en curso con inhibidores de JAK en la selección; Hgb<10 g/dl durante la selección, antes de comenzar la reducción gradual de los inhibidores de JAK
    5. Tratados previamente, con un inhibidor de JAK autorizado para la MFP o la MF post-PV/TE durante ≥90 días o ≥28 días si el tratamiento con inhibidores de JAK es complicado por la necesidad de transfusión de eritrocitos de ≥4 unidades en 8 semanas o AA de grado 3/4 de trombocitopenia, anemia, o hematoma
    - Los sujetos que interrumpieron el tratamiento con inhibidores de JAK antes de la selección no requieren un intervalo sin tratamiento adicional
    - Para los sujetos con tratamiento con inhibidores de JAK en curso en la selección, el tratamiento con el inhibidor de JAK debe reducirse gradualmente a lo largo de un período de al menos 1 semana y se iniciará un intervalo sin tratamiento 7 días antes del día I1 (el primero de 7 días consecutivos de evaluaciones iniciales de MFSAF)
    6. Esplenomegalia inicial, definida como la presencia de un bazo palpable a ≥5 cm, por debajo del MCI, o con un volumen ≥450 cm3 en la exploración por imagen (ecografía, RM o TAC son aceptables), evaluada durante la selección en cualquier momento antes de la aleatorización
    7. Riesgo alto, intermedio-2 o intermedio-1 según la definición mediante DIPSS o DIPSS-plus (criterios que se indican en el Anexo 1)
    8. Ningún alotrasplante de células madre previsto
    9. Evaluaciones analíticas aceptables:
    - RAN ≥0,75 x 109/l
    - PLAQ ≥25 × 109/l
    - Recuento da blastocitos periféricos <10 %
    - AST/SGOT y ALT/SGPT ≤3 x LSN
    - Aclaramiento de creatinina calculado ≥30 ml/min
    - Bilirrubina directa ≤2,0 × LSN
    10. Estado funcional del Grupo Oncológico Cooperativo del Este (Eastern Cooperative Oncology Group, ECOG) de 0, 1 o 2
    11. Esperanza de vida >24 semanas
    12. Capacidad para entender y voluntad de firmar el FCI
    13. Disposición y capacidad para completar las evaluaciones de RNP utilizando un dispositivo de RNPe de acuerdo con el protocolo
    14. Las MEF, los hombres con parejas en edad fértil y los sujetos con parejas embarazadas o en período de lactancia deben aceptar cumplir los requisitos de anticonceptivos del protocolo de ensayo clínico, con efecto desde la primera administración de MMB, a lo largo de todo el ensayo y durante 6 meses después de la última dosis de MMB
    E.4Principal exclusion criteria
    1. Use of the following treatments within the time periods noted (criteria a-i), restricted therapies are further described in protocol section 5.3.3.
    2. History of prostate cancer, with the exception of localized prostate cancer that has been treated surgically or by radiotherapy with curative intent and presumed cured
    3. Prostate specific antigen (PSA) > 4 ng/mL
    4. Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo an MRI or CT scan for spleen volume measurement per protocol requirements in Section 8.3
    5. Any of the following (criteria a-k):
    a. Uncontrolled intercurrent illness including, but not limited to: active uncontrolled infection (subjects receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial)
    b. Significant active or chronic bleeding event ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to Randomization
    c. Unstable angina pectoris within 6 months prior to Randomization
    d. Symptomatic congestive heart failure within 6 months prior to Randomization
    e. Uncontrolled cardiac arrhythmia within 6 months prior to Randomization
    f. QTcF interval > 500 msec, unless attributed to bundle branch block
    g. Current progressive thrombosis despite treatment
    h. History of porphyria
    i. Child-Pugh score ≥ 10
    j. Psychiatric illness, social situation, or any other condition that would limit compliance with trial requirements or may interfere with the interpretation of study results, as judged by investigator or sponsor
    k. Inability or unwillingness to comply with the protocol restrictions on MF therapy and other medications prior to and during study treatment
    6. Subjects with a prior or concurrent malignancy, whose natural history or treatment has a significant potential to interfere with the safety or efficacy assessment of the investigational regimen
    7. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
    8. Known positive status for HIV
    9. Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier (testing required for hepatitis B and C)
    10. Unresolved non-hematologic toxicities from prior therapies that are > Grade 1 per CTCAE v5.0
    11. Presence of peripheral neuropathy ≥ Grade 2 per CTCAE v5.0
    12. Women who are already pregnant or lactating
    13. Known intolerance or hypersensitivity to MMB or DAN, their metabolites, or formulation excipients.
    14. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Note: DAN capsules contain lactose, further details are provided in protocol section 1.6.3.
    1. Uso de los siguientes tratamientos en los períodos de tiempo indicados (criterios a i); los tratamientos restringidos se describen con más detalle en la Sección del protocolo 5.3.3.
    2. Antecedentes de cáncer de próstata, con la excepción del cáncer de próstata localizado que se ha tratado quirúrgicamente o con radioterapia con intención curativa y presuntamente curado
    3. Antígeno prostático específico (PSA) >4 ng/ml
    4. No apto para mediciones del volumen del bazo debido a esplenectomía previa o no estar dispuesto o no poder someterse a una exploración por TAC o RM para la medición del volumen del bazo de acuerdo con los requisitos del protocolo de la Sección 8.3
    5. Cualquiera de los siguientes criterios a-k:
    a. Enfermedad intercurrente no controlada, entre otras, infección activa no controlada (los sujetos que reciben de manera ambulatoria fármacos antibacterianos y/o tratamientos antivirales para una infección que está bajo control o como profilaxis de infecciones se pueden incluir en el ensayo)
    b. Acontecimiento hemorrágico significativo activo o crónico de grado ≥2 según los criterios terminológicos comunes para acontecimientos adversos (Common Terminology Criteria for Adverse Events, CTCAE) v 5.0, dentro de las 4 semanas anteriores a la aleatorización
    c. Angina de pecho inestable en los 6 meses anteriores a la aleatorización
    d. Insuficiencia cardíaca congestiva sintomática dentro de los 6 meses anteriores a la aleatorización
    e. Arritmia cardíaca no controlada en los 6 meses anteriores a la aleatorización
    f. Intervalo QTcF>500 ms, salvo que sea atribuible a un bloqueo de rama
    g. Trombosis progresiva actual a pesar del tratamiento
    h. Antecedentes de porfiria
    i. Puntuación de Child-Pugh ≥10
    k. Incapacidad o falta de voluntad de cumplir las restricciones del protocolo relativas al tratamiento de la MF y otros medicamentos antes y durante el tratamiento del estudio
    6. Sujetos con una neoplasia maligna anterior o concurrente, cuya evolución natural o tratamiento tiene un gran potencial de interferir con la evaluación de la seguridad o la eficacia del tratamiento en investigación
    7. Anemia conocida clínicamente significativa debida a deficiencia de hierro, vitamina B12 o folato, o anemia hemolítica autoinmune o hereditaria, o hemorragia gastrointestinal
    8. Resultado positivo conocido de VIH
    9. Hepatitis vírica A, B, o C crónica activa o aguda o portador de hepatitis B o C (se requieren pruebas de hepatitis B y C)
    10. Toxicidades no hematológicas no resueltas derivadas de tratamientos anteriores que sean de grado >1 según los CTCAE, v 5.0
    11. Presencia de neuropatía periférica de grado ≥2 según CTCAE, versión 5.0.
    12. Mujeres embarazadas o en período de lactancia.
    13. Intolerancia o hipersensibilidad conocidas a MMB o DAN, sus metabolitos o los excipientes de las formulaciones.
    14. Los pacientes con problemas hereditarios raros de intolerancia a la galactosa, deficiencia de lactasa Lapp o malabsorción de glucosa-galactosa. Nota: Las cápsulas de DAN contienen lactosa, se proporcionan más detalles en la Sección 1.6.3.
    E.5 End points
    E.5.1Primary end point(s)
    The MFSAF TSS response rate at Week 24. TSS response rate is defined as the proportion of subjects who achieve a ≥ 50% reduction in TSS over the 28 days immediately prior to the end of Week 24 compared to baseline.
    La tasa de respuesta de la PTS del MFSAF en la semana 24. La tasa de respuesta de la PTS se define como la proporción de sujetos que logran una reducción ≥50 % en la PTS en los 28 días inmediatamente anteriores del final de la semana 24 en comparación con el inicio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    TSS response at Week 24 is the primary endpoint. The MFSAF TSS response rate at Week 24 is defined as the proportion of subjects who achieve a ≥ 50% reduction compared with the TSS at baseline.
    La tasa de respuesta de la PTS en la semana 24 es el criterio de valoración principal. La tasa de respuesta de la PTS del MFSAF en la semana 24 está definida como la proporción de sujetos que logran una reducción ≥50 % en comparación con la PTS al inicio.
    E.5.2Secondary end point(s)
    • Proportion of subjects with TI status at the end of Week 24; defined as not requiring RBC transfusion (except in the case of clinically overt bleeding) for ≥ 12 weeks immediately prior to the end of Week 24, with Hgb level ≥ 8 g/dL. Assessed in all subjects
    • SRR; defined as the proportion of subjects who have splenic response (reduction in spleen volume of ≥ 35% from baseline) at the end of Week 24
    • Other secondary endpoints include: measures of anemia benefit and duration of response, mean change from baseline MFSAF TSS, safety assessments, survival analyses, change from baseline in PROs, and plasma concentration of MMB.
    • Proporción de pacientes con estado IT al final de la semana 24; definido como sin necesidad de transfusiones de eritrocitos (excepto en el caso de hemorragia clínicamente manifiesta) durante ≥12 semanas inmediatamente antes del final de la semana 24, con un nivel de Hb ≥8 g/dl. TRE evaluada en todos los sujetos;
    • PTS: definida como la proporción de sujetos que presentan respuesta esplénica (reducción en el volumen del bazo ≥35 % desde el inicio) al final de la semana 24
    • Otros criterios de valoración secundarios son: medidas del beneficio en la anemia y duración de la respuesta, media del cambio desde el inicio en la PTS del MFSAF, evaluaciones de la seguridad, análisis de la supervivencia, cambio desde el inicio en los RNP y concentración plasmática de MMB.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The proportion of subjects who have TI status in the terminal 12 weeks of the 24-week Randomized Treatment Period, will be assessed in all subjects. Analysis of TI status will be performed on the ITT analysis set using a CMH test, stratified by baseline MFSAF TSS, baseline spleen length, and baseline RBC units transfused.
    Se evaluará para todos los sujetos la proporción de sujetos que tienen un estado IT en las 12 semanas finales del período de tratamiento aleatorizado de 24 semanas. El análisis del estado IT se realizará en el conjunto de análisis ITT utilizando una prueba de CMH, estratificada por puntuación PTS del MFSAF inicial, longitud inicial del bazo y unidades de eritrocitos transfundidas al inicio.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Blood samples will be collected for assessments including mutational analysis via next generation sequencing (NGS)
    Se recogerán muestras de sangre para las evaluaciones, incluidas el análisis de mutaciones mediante secuenciación de última generación (SUG).
    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 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 Yes
    E.8.1.7Other No
    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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA110
    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
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    New Zealand
    Poland
    Romania
    Singapore
    Spain
    Sweden
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of trial is defined as the date when the last subject has completed the Safety Follow-Up visit or Survival Follow-Up assessment (whichever is later).
    El fin de ensayo está definido como la fecha cuando el ultimo paciente haya completado la visita de seguimiento de seguridad o la visita de seguimiento de supervivencia (lo que ocurra posterior)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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: 81
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 189
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 270
    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)
    The Safety Follow-Up Visit will occur 30 days after the last dose then survival Follow-Up assessments will occur every 3 months post-last dose to 7 years post-first dose Long term care to the patient will be their primary treating physician's responsibility.
    La visita de seguimiento de seguridad se realizará 30 días después de la última dosis, luego las evaluaciones de seguimiento de supervivencia se realizarán cada 3 meses después de la última dosis a 7 años después de la primera dosis.
    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 Decision2020-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-24
    P. End of Trial
    P.End of Trial StatusRestarted
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