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    Summary
    EudraCT Number:2012-002471-34
    Sponsor's Protocol Code Number:AZA-MDS-003
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2012-002471-34
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-Dependent Anemia And Thrombocytopenia due to IPSS Lower-Risk Myelodysplastic Syndromes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With lack of normal Red Blood Cells requiring Transfusion and low platelets in the blood Due to Lower Risk Myelodysplastic Syndrome (MDS)
    A.3.2Name or abbreviated title of the trial where available
    QUAZAR lower-risk MDS
    A.4.1Sponsor's protocol code numberAZA-MDS-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01566695
    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 SponsorCelgene 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 supportCelgene Corporatiron
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9900 W. 109th Street, Suite 300, Building 70, Overland Park
    B.5.3.2Town/ cityKansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18882601599
    B.5.5Fax number+19134513459
    B.5.6E-mailClinicalTrialDisclosure@celgene.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/3/01/084
    D.3 Description of the IMP
    D.3.1Product nameOral Azacitidine
    D.3.2Product code CC-486
    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 INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    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: 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/3/01/084
    D.3 Description of the IMP
    D.3.1Product nameOral Azacitidine
    D.3.2Product code CC-486
    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 INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    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 placeboFilm-coated tablet
    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
    Subjects with Red Blood Cell Transfusion-Dependent Anemia and Thrombocytopenia due to IPSS Lower-Risk Myelodysplastic Syndromes
    E.1.1.1Medical condition in easily understood language
    Subjects with a lack of normal red blood cells requiring a transfusion and low platelets in the blood caused by lower risk myelodysplastic syndrome
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10068361
    E.1.2Term MDS
    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 evaluate RBC transfusion independence in the 2 treatment arms (oral azacitidine plus best supportive care versus placebo plus best supportive care) in subjects with RBC transfusion-dependent anemia and thrombocytopenia (platelet count ≤ 50 x
    109/L) due to IPSS lower-risk MDS.
    E.2.2Secondary objectives of the trial
    To evaluate in both treatment arms:
    - overall survival (OS);
    - hematologic improvement-platelet response (HI-P);
    - duration of RBC transfusion independence and time to RBC transfusion independence;
    - progression to acute myeloid leukemia (AML), and time to AML progression;
    - hematologic improvement-erythroid response (HI-E);
    - platelet-transfusion independence, duration of platelet transfusion independence, and time to platelet transfusion independence;
    - hematologic response;
    - clinically significant bleeding events;
    - safety;
    - health-related quality-of-life (HRQoL); and
    - healthcare resource utilization.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years at the time of signing the informed consent document
    2. Have a documented diagnosis of MDS according to WHO 2008 classification
    3. Be RBC transfusion-dependent as defined by:
    - Average transfusion requirement of ≥ 2 units** per 28 days of RBCs confirmed for a minimum of 84 days immediately preceding randomization
    *Hemoglobin levels at the time of or within 7 days prior to administration of an RBC transfusion must have been ≤ 9.0 g/dL in order for the transfusion to be counted towards RBC transfusion-dependent status. Red blood cell transfusions administered when Hgb levels were > 9.0 g/dL and/or RBC transfusions
    administered for elective surgery will not qualify as a required transfusion for the purpose of providing evidence of RBC transfusion-dependent status
    * No consecutive 42 days that are RBC-transfusion-free during the 84 days immediately preceding randomization
    4. Have thrombocytopenia as defined by two platelet counts that are ≤ 50 x 109/L and ≥ 21 days apart. The second confirmatory platelet count must be obtained ≤ 14 days prior to randomization
    - If additional platelet counts were obtained during the interim period, these must also have been ≤ 50 x 109/L. Platelet counts > 50 x 109/L within the interim period are acceptable only if directly associated with a platelet transfusion administered within 7 days prior to the date of the platelet count
    5. Have an ECOG performance status of 0, 1, or 2
    6. Females of childbearing potential (FCBP) may participate, providing they meet the
    following conditions:
    - Agree to use at least two effective contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study, and for 3 months following the last dose of study drug; and
    - Have a negative serum or urine pregnancy test (investigator’s discretion; sensitivity of at least 25 mIU/mL) at screening; and
    - Have a negative serum or urine pregnancy test (investigator’s discretion) within 72 hours prior to starting study therapy in the treatment phase (note that the screening serum pregnancy test can be used as the test prior to starting study therapy in the treatment phase if it is performed within the 72-hour timeframe)
    7. Male subjects with a female partner of childbearing potential must agree to the use of at least two physician-approved contraceptive methods throughout the course of the study and should avoid fathering a child during the course of the study and for 3 months following the last dose of study drug
    E.4Principal exclusion criteria
    1. IPSS higher-risk (INT-2 or High risk) MDS
    2. Secondary MDS, ie MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases
    3. Hypoplastic MDS or other subtype with eligibility for treatment with immunotherapy
    4. CMML, atypical chronic myeloid leukemia (CML) and unclassifiable myeloproliferative disease (MPD)
    5. Prior treatment with any of the following:
    - Azacitidine (any formulation), decitabine or other hypomethylating agent
    - Lenalidomide
    6. Prior allogeneic or autologous stem cell transplant
    7. History of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity
    8. Thrombocytopenia secondary to other possible causes, including medication(s), congenital disorder(s), immune disorder(s) (eg, idiopathic thrombocytopenic purpura [ITP]), or microvascular disorder(s) (eg, disseminated intravascular coagulation, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura)
    9. Use of any of the following within 28 days prior to randomization:
    - cytotoxic, chemotherapeutic, targeted or investigational agents/therapies
    - thrombopoiesis-stimulating agents (TSAs; eg, Romiplostim, Eltrombopag, Interleukin-11)
    - ESAs and other RBC hematopoietic growth factors (eg, Interleukin-3)
    - hydroxyurea
    10. Ongoing adverse events from previous treatment, regardless of the time period
    11. Concurrent use of any of the following:
    - iron-chelating agents, except for subjects on a stable dose for at least 8 weeks (56 days) prior to randomization
    - corticosteroid, except for subjects on a stable or decreasing dose for ≥ 1 week prior to randomization for medical conditions other than MDS
    12. Prior history of malignancies, other than MDS, unless the subject has been free of the disease for ≥ 3 years. However, subjects with the following history/concurrent conditions are allowed:
    - Basal or squamous cell carcinoma of the skin
    - Carcinoma in situ of the cervix
    - Carcinoma in situ of the breast
    - Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system)
    13. Significant active cardiac disease within the previous 6 months, including:
    - New York Heart Association (NYHA) class IV congestive heart failure;
    - Unstable angina or angina requiring surgical or medical intervention; and/or
    - Myocardial infarction
    14. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate
    antibiotics, antiviral therapy, and/or other treatment)
    15. Known Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection
    16. Abnormal coagulation parameters (PT > 15 seconds, PTT > 40 seconds, and/or INR > 1.5)
    17. Any of the following laboratory abnormalities:
    - Serum AST/SGOT or ALT/SGPT > 2.5 x upper limit of normal (ULN)
    - Serum bilirubin > 1.5 x ULN. Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis). Subjects are excluded if there is evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of > 2% with either a positive Coombs’ test or over 50% of indirect bilirubin
    - Serum creatinine > 2.5 x ULN
    18. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding. Iron deficiency would be determined by a bone marrow aspirate stain for iron, the transferrin saturation (iron/total iron binding capacity [Fe/TIBC] ≤ 20%), or serum ferritin ≤ 15 ng/dL
    19. Known or suspected hypersensitivity to azacitidine or mannitol
    20. Pregnant or lactating females
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects in the overall population achieving RBC transfusion independence with duration ≥ 84 days (12 weeks).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After all patients have either completed 12 months treatment or discontinued
    E.5.2Secondary end point(s)
    - OS;
    - HI-P (IWG 2006 criteria);
    - Duration of RBC transfusion independence;
    - Time to RBC transfusion independence;
    - Proportion of subjects progressing to AML and time to AML progression;
    - HI-E (IWG 2006 criteria);
    - Proportion of platelet transfusion-dependent subjects at baseline achieving platelet transfusion independence with duration ≥ 56 days (8 weeks);
    - Duration of platelet transfusion-independence;
    - Time to platelet transfusion independence;
    - Hematologic response (IWG 2006 criteria);
    - Proportion of subjects experiencing clinically significant bleeding events;
    - Safety (type, frequency, severity of AEs and relationship of AEs to oral azacitidine/placebo; monitoring for progression to AML and second primary malignancy);
    - HRQoL utilizing the Functional Assessment of Cancer Therapy-Anemia (FACT-An) and EuroQoL Group EQ-5D-3L instruments; and
    - Measures of healthcare resource utilization.

    Exploratory:

    -Correlative analyses to assess the relationship between azacitidine exposure and pharmacodynamic (eg, safety, efficacy) and other exploratory (eg, biomarker) endpoints.
    - Biomarker assessments (molecular and/or cellular features in bone marrow and/or peripheral blood) potentially include, but are not limited to, cytogenetics, DNA methylation, gene variants (single nucleotide polymorphisms [SNPs] and gene
    sequence) analysis, messenger ribonucleic acid (mRNA) expression, micro RNA (miRNA) expression, RNA methylation, immunophenotyping and plasma protein evaluation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints including interim OS with exception of AML progression: after all patients have either completed 12 months treatment or discontinued

    Mature OS: Approx 250 events per arm.
    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 No
    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) 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 Yes
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Lithuania
    Mexico
    Netherlands
    Norway
    Poland
    Portugal
    Spain
    Sweden
    United Kingdom
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 213
    F.4.2.2In the whole clinical trial 386
    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)
    Standard of care
    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 Decision2013-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-21
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