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    Summary
    EudraCT Number:2017-001398-17
    Sponsor's Protocol Code Number:M16-109
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-001398-17
    A.3Full title of the trial
    A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis
    Studio Clinico in Aperto di Fase 2 per Valutare la Tollerabilità e l’Efficacia di Navitoclax da Solo o in Combinazione con Ruxolitinib in Soggetti affetti da Mielofibrosi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis
    Studio clinico in aperto per valutare la tollerabilità e l’efficacia di Navitoclax somministrato da solo oppure in combinazione con Ruxolitinib in soggetti affetti da mielofibrosi
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberM16-109
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628561090
    B.5.5Fax number00441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNavitoclax
    D.3.2Product code [ABT-263]
    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 INNNavitoclax
    D.3.9.1CAS number 923564-51-6
    D.3.9.2Current sponsor codeABT-263
    D.3.9.4EV Substance CodeSUB171635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNavitoclax
    D.3.2Product code [ABT-263]
    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 INNNavitoclax
    D.3.9.1CAS number 923564-51-6
    D.3.9.2Current sponsor codeABT-263
    D.3.9.4EV Substance CodeSUB171635
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Jakavi
    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.3.1Product nameJakavi
    D.3.2Product code [na]
    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 INNRuxolitinib
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB32273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Myelofibrosis
    Mielofibrosi
    E.1.1.1Medical condition in easily understood language
    Bone marrow disorder that disrupts body's normal production of blood cells. The result is extensive scarring in bone marrow, leading to severe anemia, weakness, fatigue and an enlarged spleen.
    Disturbo del midollo osseo che ferma la normale produzione di cellule del sangue. Con un'ampia cicatrizzazione nel midollo osseo, con grave anemia, debolezza, affaticamento, ingrossamento della milza.
    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
    Evaluate the effect of navitoclax alone or in combination with ruxolitinib on spleen volume
    Valutare l’effetto di navitoclax da solo o in combinazione con ruxolitinib sul volume splenico
    E.2.2Secondary objectives of the trial
    - To assess the effect of navitoclax alone or in combination with ruxolitinib on total symptom score (TSS) as assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0 diary
    - To evaluate the effect of navitoclax alone or in combination with ruxolitinib on bone marrow fibrosis
    - To determine the overall response rate (ORR = sum of rates of complete remission [CR] + partial remission [PR]) associated with navitoclax alone or in combination with ruxolitinib
    - To determine the rate of anemia response associated with navitoclax alone or in combination with ruxolitinib
    - To describe the safety profile and PK profile observed with navitoclax alone or in combination with ruxolitinib
    - Valutare l’effetto di navitoclax da solo o in combinazione con ruxolitinib sul punteggio totale dei sintomi TSS (total symptom score) valutato in base al diario MFSAF (Myelofibrosis Symptom Assessment Form) versione 4.0
    - Valutare l’effetto di navitoclax da solo o in combinazione con ruxolitinib sulla fibrosi midollare
    - Determinare il tasso di risposta globale (ORR = somma dei tassi di remissione completa [CR] + remissione parziale [PR]) associato a navitoclax da solo o in combinazione con ruxolitinib
    - Determinare il tasso di risposta dell’anemia associata a navitoclax da solo o in combinazione con ruxolitinib
    - Descrivere il profilo di sicurezza e il profilo di PK osservati con navitoclax da solo o in combinazione con ruxolitinib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects = 18 years of age
    - Subjects with documented diagnosis of Intermediate or High-risk
    Primary myelofibrosis, post-polycythemia vera myelofibrosis or postessential
    thrombocythemia myelofibrosis
    - Subjects classified as intermediate-2 or high-risk myelofibrosis, as
    defined by the Dynamic International Prognostic Scoring System
    (DIPSS)
    - Subject must be ineligible or unwilling to undergo stem cell
    transplantation at time of study entry
    - Subject must have either received prior treatment with ruxolitinib OR
    another JAK-2 inhibitor therapy OR must not have received any prior treatment with JAK-2 inhibitor or BET inhibitor.
    - Subject has palpable splenomegaly.
    - Subject must meet the laboratory parameters (adequate bone marrow,
    renal and hepatic function) as defined in the protocol.
    - Cohorts 1b and 3 only: Subject has at least 2 symptoms each with a
    score = 3 or a total score of = 12, as measured by the MFSAF v4.0.
    - Soggetti di età =18 anni.
    - Soggetti con diagnosi documentata di mielofibrosi primaria, mielofibrosi post-policitemia vera oppure mielofibrosi post-trombocitemia essenziale secondo i criteri dell’Organizzazione Mondiale della Sanità.
    -Soggetti classificati a rischio intermedio -2 o rischio elevato, secondo i criteri del Sistemi di punteggio
    prognostico internazionale dinamico (DIPSS)
    - Il soggetto deve essere non eleggibile o non disponibile a sottoporsi al trapianto di cellule staminali al momento dell’ingresso nello studio
    - Il soggetto deve aver ricevuto terapia pregressa con ruxolitinib OPPURE con un altro JAK-2 inibitore OPPURE non deve aver ricevuto alcun trattamento pregresso con un JAK-2 inibitore o BET inhibitore.
    - Il soggetto presenta splenomegalia identificabile alla palpazione
    - Il soggetto deve soddisfare i parametri di laboratorio (funzione midollare, renale ed epatica adeguata) definiti nel protocollo.
    - • Solo coorti 1b e 3: il soggetto presenta almeno 2 sintomi ciascuno con un punteggio = 3 o un punteggio
    totale di = 12, misurato dall'MFSAF v4.0.
    E.4Principal exclusion criteria
    - Splenic irradiation within 6 months prior to screening, or prior
    splenectomy.
    - Leukemic transformation (> 10% blasts in peripheral blood or bone
    marrow biopsy).
    - Subject is currently on medications that interfere with coagulation
    (including warfarin) or platelet function with the exception of low dose
    aspirin (up to 100 mg) and Low-molecular-weight heparin.
    - Prior therapy with a BH3 mimetic compound.
    - Cohort 1b only: Subject has received strong or moderate CYP3A
    inhibitors within 14 days prior to the administration of the first dose of
    navitoclax.
    - Irradiazione splenica nei 6 mesi precedenti lo Screening, oppure pregressa splenectomia
    - Trasformazione leucemica (> 10% blasti nel sangue periferico o in campione di biopsia osteomidollare)
    - Soggetto attualmente in trattamento con medicinali in grado di interferire con la coagulazione (compreso il warfarin) o con la funzione piastrinica, ad eccezione dell’aspirina a bassa dose (fino a 100 mg) e dell’eparina a basso peso molecolare
    - Terapia pregressa con un BH3-mimetico
    - Solo soggetti sottoposti a studio di interazione farmaco-farmaco (DDI) della coorte 1b:Il soggetto ha ricevuto inibitori potenti o moderati del CYP3A nei 14 giorni precedenti la somministrazione della prima dose di navitoclax
    E.5 End points
    E.5.1Primary end point(s)
    = 35% spleen volume reduction from baseline (SVR35) at Week 24
    measured by MRI/CT.
    Almeno una riduzione del 35% alla settimana 24 (SVR35w24) del volume splenico rispetto al baseline misurata
    tramite RM/TAC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    E.5.2Secondary end point(s)
    The secondary endpoints are at least 50% reduction in total symptom
    score from baseline measured by MFSAF 4.0; anemia response; and
    change in grade of bone marrow fibrosis.
    Endpoint Secondori di Efficacia:
    • Almeno una riduzione del 50% del punteggio Total Symptom Score (TSS) alla settimana
    24 rispetto al baseline misurata tramite MFSAF v4.
    • Tasso di risposta dell’anemia
    • Variazione di grado di fibrosi midollare
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    in aperto
    in open
    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 trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 Information not present in EudraCT
    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
    Canada
    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
    The end-of-study is defined as the date of the last subject's last visit or date of last follow-up contact, whichever is later.
    La fine dello studio è definita come la data dell'ultima visita dell'ultimo soggetto o la data dell'ultimo contatto di follow-up, a seconda di quale data successiva.
    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 months6
    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 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 164
    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)
    At the subject's treatment completion visit, the investigator will discuss the appropriate subsequent treatment with the subject. AbbVie will not provide navitoclax or any other therapy once the subject's participation is concluded.
    Alla visita di fine trattamento del soggetto, il medico sperimentatore discuterà con lo stesso dell’appropriato trattamento successivo. AbbVie non fornirà navitoclax oppure qualsiasi altra terapia una volta conclusa la partecipazione del soggetto
    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 Decision2020-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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