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    Summary
    EudraCT Number:2012-005805-36
    Sponsor's Protocol Code Number:CC-486-AML-002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-20
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2012-005805-36
    A.3Full title of the trial
    A Phase 1/2, Dose and Schedule Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Azacitidine (CC-486) in Subjects with Acute Myeloid Leukemia or Myelodysplastic Syndromes after Allogeneic Hematopoietic Stem Cell Transplantation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety study of oral azacitidine (CC-486) in patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes experiencing no symptom of the disease after stem cell transplantation
    A.3.2Name or abbreviated title of the trial where available
    Quazar Post Transplant
    A.4.1Sponsor's protocol code numberCC-486-AML-002
    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 Corporation
    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 Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 888 260 1599
    B.5.5Fax number+1 913 266 0394
    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 and EU/3/07/509
    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 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: 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 and EU/3/07/509
    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: 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/3/01/084 and EU/3/07/509
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with acute myeloid leukemia or myelodysplastic syndromes in morphological remission after allogeneic hematopoietic stem cell transplantation.
    E.1.1.1Medical condition in easily understood language
    Subjects with Acute Myeloid Leukemia (AML) or Myelodysplatic Syndromes (MDS) experiencing no symptom of the disease after stem cell transplantation.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10000887
    E.1.2Term Acute myeloid leukemia in remission
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10028533
    E.1.2Term Myelodysplastic syndrome
    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 maximal tolerated dose (MTD) of oral azacitidine in subjects with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) after allogeneic hematopoietic stem cell transplantation (HSCT).
    E.2.2Secondary objectives of the trial
    1) To determine the safety and tolerability of oral azacitidine in this subject population.
    2) To assess the pharmacokinetics (PK) profile of oral azacitidine and to explore the relationships of azacitidine exposure with safety and efficacy endpoints.
    3) To assess the preliminary efficacy of oral azacitidine in this subject population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years at the time of signing the ICD
    2. Diagnosis of MDS or AML according to WHO classification undergoing allogeneic HSCT using MAC, NMA or RIC preparative regimens (Bacigalupo, 2009), and with either peripheral blood or bone marrow as the source of hematopoietic stem cells
    3. At the time of allogeneic HSCT:
    • No prior allogeneic HSCT; and
    • No more than 1 antigen mismatch at HLA-A, -B, -C, -DRB1 or -DQB1 locus for either related or unrelated donor; and
    • Bone marrow blast < 20% if MDS or ≤ 10% if AML; and
    • Peripheral blood blast ≤ 5%
    4. Be able to start study therapy between 42 to 84 days following allogeneic HSCT
    5. Post transplant bone marrow blast count ≤ 5% confirmed within 21 days prior to starting study therapy
    6. Adequate engraftment within 14 days prior to starting study therapy:
    • ANC ≥ 1.0 x 10*9/L without daily use of myeloid growth factor; and
    • Platelet ≥ 75 x 10*9/L without platelet transfusion within 1 week
    7. Adequate organ function:
    • Serum AST/SGOT and ALT/SGPT < 3 x upper limit of normal (ULN)
    • Serum bilirubin < 2 x ULN. Higher levels are acceptable if these can be attributed to active RBC precursor destruction within the bone marrow (ie, ineffective erythropoiesis) or Gilbert’s syndrome
    • Serum creatinine < 2 x ULN
    8. Adequate coagulation (PT ≤ 15 seconds, PTT ≤ 40 seconds, and/or INR ≤ 1.5)
    9. ECOG performance status of 0, 1 or 2
    10. 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 Investigational Product; and
    • Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL) at screening; and
    • Have a negative serum or urine (investigator’s discretion) pregnancy test (sensitivity of at least 25 mIU/mL) within 72 hours prior to starting study therapy in the treatment phase (note that the screening 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)
    11. 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 Investigational Product
    E.4Principal exclusion criteria
    1. Use of any of the following after transplantation and prior to starting study therapy:
    • Chemotherapeutic agents for chemotherapy (note that prophylactic use of these agents is allowed in this study, eg, methotrexate for GVHD)
    • Investigational agents/therapies
    • Azacitidine, decitabine or other demethylating agents
    • Lenalidomide, thalidomide and pomalidomide
    2. Active GVHD grade II or higher
    3. Any evidence of gastrointestinal (GI) GVHD
    4. Concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg
    5. Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
    6. Active 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)
    7. Prior to allogeneic HSCT, history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other GI disorder or defect that may interfere with the absorption, distribution, metabolism or excretion of the Investigational Product and/or predispose the subject to an increased risk of gastrointestinal toxicity
    8. Idiopathic thrombocytopenic purpura [ITP], disseminated intravascular coagulation, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura [TTP]
    9. Prior history of malignancies, other than MDS or AML, unless the subject has been free of the disease for ≥ 1 year. 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, node, metastasis [TNM] clinical staging system)
    10. Significant active cardiac disease within the previous 6 months, including:
    • New York Heart Association (NYHA) class III or IV congestive heart failure
    • Unstable angina or angina requiring surgical or medical intervention; and/or
    • Myocardial infarction
    11. Known or suspected hypersensitivity to azacitidine or mannitol
    12. Pregnant or lactating females
    13. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
    14. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
    15. Any condition that confounds the ability to interpret data from the study
    E.5 End points
    E.5.1Primary end point(s)
    Maximum tolerated dose (MTD) of oral azacitidine in subjects with AML or MDS after allogeneic HSCT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of each cycle of Cycles 1 to 2
    E.5.2Secondary end point(s)
    - Safety (type, frequency, severity of AEs and relationship of AEs to oral azacitidine; progression to AML for MDS subjects)
    - Incidence of acute and chronic graft-versus-host disease (GVHD)
    - Time to discontinuation from treatment
    - Plasma PK parameters including, but not limited to, area under the curve (AUC), half-life (t½), observed maximum concentration (Cmax), time at which maximum concentration is observed (tmax), and others as appropriate
    - Disease recurrence/relapse rate
    - Time to disease recurrence/relapse
    - Overall survival and relapse-free survival (RFS) at one year following allogeneic HSCT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For Safety (which includes Time to discontinuation from treatment) and GVHD: on an ongoing basis;
    For PK: several time points from Cycle 1 to Cycle 7;
    For Efficacy (which involves Disease recurrence/relapse rate, Time to disease recurrence/relapse, Overall survival and relapse-free survival (RFS) at one year following allogeneic HSCT): every six months during the first year after transplantation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/II
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study is planned to conclude approximately 18 months after the last subject initiates study therapy.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 30
    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)
    If deemed necessary or useful by the investigator and with approval from the sponsor’s Medical Monitor, subjects who are continuing to receive study treatment when the maximal duration of oral azacitidine therapy is reached (ie, 12 months), and do not meet any of the criteria for treatment discontinuation, will have the option of continuing study treatment until study closure, at which time subjects may continuing study treatment through options such as a separate open-label extension study.
    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 Decision2013-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-18
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