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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2020-002771-35
    Sponsor's Protocol Code Number:INCB00928-105
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-002771-35
    A.3Full title of the trial
    A Phase 1/2, Open-Label, Multicenter Study of INCB000928
    Administered as a Monotherapy in Participants With Anemia Due to
    Myelodysplastic Syndromes or Multiple Myeloma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma
    A.4.1Sponsor's protocol code numberINCB00928-105
    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 SponsorIncyte Corporation
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.5Fax number13034252734
    B.5.6E-mailRegAffairs@incyte.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.3.2Product code INCB000928
    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.3.9.2Current sponsor codeINCB000928
    D.3.9.3Other descriptive nameINCB000928 fumarate dihydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeINCB000928
    D.3.9.3Other descriptive nameINCB000928 fumarate dihydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Participants who are transfusion-dependent or present with symptomatic anemia; for MDS participants who are ineligible to receive or have not responded to available therapies for anemia and for MM after failure of available standard treatments.
    E.1.1.1Medical condition in easily understood language
    Participants with symptomatic anemia; for MDS participants who are ineligible to receive or not responded to available therapies for anemia, and for MM after failure of standard treatments.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of INCB000928
    monotherapy in participants with MDS or MM.
    E.2.2Secondary objectives of the trial
    To determine the efficacy of INCB000928 in participants with MDS or MM.
    To evaluate the PK of INCB000928 in participants with MDS or MM.
    To evaluate the effect of INCB000928 on the iron homeostasis and the erythropoiesis parameters in participants with MDS or MM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to comprehend and willingness to sign a written ICF for the study.
    2. Age 18 years or older at the time of signing the ICF.
    3. ECOG performance status of the following:
    a. 0 or 1 for the dose-escalation stages.
    b. 0, 1, or 2 for the dose-expansion stage.
    4. Life expectancy > 6 months.
    5. Agreement to avoid pregnancy or fathering children based on the criteria below:
    a. Men must agree to take appropriate precautions to avoid fathering children from screening through 90 days after the last dose of study drug
    and must refrain from donating sperm during this period.
    b. Women with childbearing potential must have a negative serum pregnancy test at
    screening before the first dose must agree to take appropriate precautions to avoid pregnancy from screening through the safety follow-up visit, and must not donate oocytes during this period.
    c. Women without childbearing potential are eligible.
    6. Participants who are transfusion-dependent or present with symptomatic anemia, defined
    as follows:
    a. Anemia: an Hgb value < 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements
    b. Transfusion-dependent: participant has received at least 4 units of RBC transfusions
    during the 28 days immediately preceding C1D1 OR has received at least 4 units of RBC transfusions in the 8 weeks immediately preceding C1D1, for an Hgb level of
    < 8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
    7. Ineligible to receive or have not responded to available therapies for anemia such as
    ESAs or lenalidomide.
    8. Not requiring cytoreductive therapy other than hydroxyurea.
    9. BM and peripheral blood myeloblast count < 10%.
    10. Histologically confirmed diagnosis of the following (according to the 2016 WHO criteria:
    a. MDS.
    b. CMML.
    c. Unclassifiable MDS/MPN overlap syndromes
    11. Histologically confirmed diagnosis of MM
    12. After failure of available standard treatments
    E.4Principal exclusion criteria
    1. Any prior allogeneic stem cell transplantation or a candidate for such transplantation.
    2. Any major surgery within 28 days before the first dose of study drug.
    3. Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy,
    biological therapy, endocrine therapy, targeted therapy, or antibody or hypomethylating
    agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter)
    before the first dose of study drug.
    a. Exceptions include glucocorticoids and hydroxyurea
    4. Undergoing treatment with another investigational medication or having been treated
    with an investigational medication within 28 days before the first dose of study drug.
    5. Undergoing treatment with ESAs, granulocyte colony-stimulating factor or
    granulocyte/macrophage colony-stimulating factor, romiplostin, or eltrombopag at any
    time within 28 days before the first dose of study drug.
    6. Undergoing treatment with a strong or potent inhibitor or inducer of CYP3A4/5 within
    28 days or 5 half-lives (whichever is longer) before the first dose of study drug or
    expected to receive such treatment during the study
    7. Any prior radiation therapy within 28 days before the first dose of study drug.
    8. Presence of any hematologic malignancy other than MDS or MM, as applicable.
    9. Active invasive malignancy over the previous 5 years
    10. Known active disease involving the CNS.
    11. History of clinically significant or uncontrolled cardiac disease
    12. History or presence of an abnormal ECG that, in the investigator's opinion, is clinically
    meaningful.
    13. Presence of chronic or current active infectious disease requiring systemic antibiotic,
    antifungal, or antiviral treatment.
    14. Diagnosis of chronic liver disease
    15. Known active hepatitis A, HBV, or HCV infection or known HIV infection.
    16. Unwillingness to be undergo transfusion with blood components, including RBC packs
    and platelet transfusions.
    17. Any condition in the investigator's judgment that would interfere with full participation in
    the study including administration of study drug and attending required study visits;
    pose a significant risk to the participant; or interfere with interpretation of study data.
    18. Active alcohol or drug addiction that would interfere with the participant's ability to
    comply with the study requirements.
    19. Gastroesophageal reflux disease not controlled by medication within 28 days before the first dose of study drug.
    20. Presence of any unresolved toxicity ≥ Grade 2 from previous therapy except for stable
    chronic toxicities (≤ Grade 2) not expected to resolve, such as stable Grade 2 peripheral
    neuropathy.
    21. Known hypersensitivity, severe reaction, or any known contraindications to the use of
    any of the active substances or excipients in INCB000928.
    22. Women who are pregnant or breastfeeding.
    23. Unable to swallow and retain oral medication.
    24. Current use of prohibited medication
    25. Participants with laboratory values at screening as defined in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    • Frequency and severity of AEs and SAEs, including changes in vital signs, ECGs, physical examinations,and clinical blood and urine laboratory parameters.
    • Identification of the DLTs, MTD, and RDE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and endpoint assessments will be performed throughout the trial
    E.5.2Secondary end point(s)
    • For transfusion-independent participants at baseline:
    − The proportion of participants with anemia response, defined as an Hgb increase of at least 1.5 g/dL relative to baseline for any 8-week period (with each assessment meeting this requirement) during the first 24 weeks of
    treatment.
    − Duration of anemia response, defined as the interval from the first onset of anemia response to the earliest date of loss of anemia response that persists for at least 4 weeks or death from any cause.
    • For transfusion-dependent participants at baseline:
    − The proportion of participants with RBC-TI, defined as the absence of any RBC transfusion for at least 8 consecutive weeks during the first 24 weeks of treatment.
    − Duration of RBC-TI period for participants achieving RBC-TI for at least 8 consecutive
    weeks during the first 24 weeks of treatment.
    • Rate of RBC transfusion through Weeks 12 and 24, defined as the average number of RBC units per participant-month during the treatment period.
    • The largest increase from baseline in the mean Hgb values over any rolling 8-week treatment period during the first 24 weeks of treatment.
    For MDS participants only:
    • Overall response rate, defined as the proportion of participants with CR or PR as per Cheson et al (2006) definitions for MDS and as per Savona et al (2015) definitions for MDS/MPN overlap syndromes, as applicable.
    • PFS, defined as the interval from the first dose of study drug until the first documented progression or death as per Cheson et al (2006) definitions for MDS and as per Savona et al (2015) definitions for MDS/MPN overlap syndromes.
    • LFS, defined as the interval from the first dose of study drug until the first documented leukemia transformation or death from any cause.
    For MM participants only:
    • Overall response rate, defined as the proportion of participants with stringent CR, CR, very good PR, and PR as per Kumar et al (2016).
    • PFS, defined as the interval from the first dose of study drug until the first documented progression or death as per Kumar et al (2016).
    • PK parameters: Cmax, tmax, and AUC0-t.
    • Blood levels of hepcidin.
    • Iron homeostasis parameters.
    • Erythropoiesis parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and endpoint assessments will be performed throughout the trial
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    France
    Italy
    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
    LVLS
    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 days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 80
    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)
    None
    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 Decision2020-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 07 20:38:05 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA