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    Summary
    EudraCT Number:2009-017775-19
    Sponsor's Protocol Code Number:CAMN107EIC01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-28
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2009-017775-19
    A.3Full title of the trial
    A Phase IIIb, multicentre, open-label study of nilotinib in adult patients with newly diagnosed Philadelphia chromosome and/or BCR-ABL positive CML in chronic phase
    A.4.1Sponsor's protocol code numberCAMN107EIC01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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/3/06/375
    D.3 Description of the IMP
    D.3.1Product namenilotinib
    D.3.2Product code AMN107
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNnilotinib
    D.3.9.1CAS number 923288-90-8
    D.3.9.2Current sponsor codeAMN107
    D.3.9.3Other descriptive nameNILOTINIB HYDROCHLORIDE MONOHYDRATE
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Newly diagnosed Philadelphia chromosome and/or BCR-ABL positive CML in chronic phase in adult patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10052065
    E.1.2Term Chronic phase chronic myeloid leukaemia
    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 the rate of MR4.0 at 18 months of nilotinib treatment
    E.2.2Secondary objectives of the trial
    • To evaluate the rate of annual progression and annual events at 12 and 24 months of treatment
    • To evaluate the rate of major molecular response at, as well as by, 12 and 24 months of treatment
    • To evaluate the rate of complete and major cytogenetic response at, as well as by, 12 and 24 months of treatment
    • To evaluate the rate of MR4.0 and MR4.5 at, as well as by, 12 and 24 months of treatment
    •To evaluate the rate of CHR at, as well as by, 12 and 24 months of treatment
    •To evaluate the annual rate of progressions and annual rate of events in patients achieving a MR4.0 at 12 months of treatment.
    • To evaluate the Event-Free Survival (EFS) and Overall Survival (OS) at 12 months and at 24 months of treatment
    •To evaluate the rate of MR4.0 by 18 months of treatment
    • To evaluate the safety and tolerability profile of nilotinib
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Sub-study: Biomarkers analysis as potential predictors of complete molecular response to nilotinib (CMR)
    2. Multi-national sub-study: Stem cell identification and quantification in predicting response to first line
    nilotinib treatment in patients with newly-diagnosed chronic myeloid leukemia
    3. Multi-national sub-study: Immunological monitoring during first line treatment with nilotinib in early chronic
    phase CML
    4. Multi-national sub-study: Determination of plasma nilotinib levels (pharmacokinetics) and single cell
    quantification of phosphoprotein response (pharmacodynamics) during nilotinib treatment in early chronic
    phase CML
    5. Sub-study: Evaluation of nilotinib plasma trough-levels and correlation with clinical response
    6. Multi-national sub-study: Correlation of Genome wide DNA methylation profiling and Sokal risk and
    response to treatment
    7. Multi-national sub-study: Genetic and transcriptional prognostic and predictive markers in CML
    8. Sub-study: Adherence to treatment and quality of life of patients receiving nilotinib as first-line therapy for
    CML
    9. Multi-national sub-study: Adherence to nilotinib first line treatment
    10. Sub-study: Interaction of Ph+ stem cell to bone marrow microenvironment and pre-treatment ABL mutation
    as biological determinants of response in CML patients treated frontline with nilotinib
    11. Sub-study: Analysis of potential biomarkers in leukemic stem cells for predicting response to nilotinib treatment
    E.3Principal inclusion criteria
    Patients must meet all inclusion criteria and none of the exclusion criteria to enter the study. Patients must meet all inclusion criteria within 2 weeks of the start of study treatment (bone marrow examinations may be within 8 weeks) to enter the study.
    • Male or female patients with diagnosis of CP-CML with
    cytogenetic confirmation of Ph chromosome [t(9;22)
    translocation] (if the bone marrow sample is taken within 8 weeks
    of study start but before the patient consents, the bone marrow
    should not be repeated after the patient formally consents to the
    study)
    • Ph negative cases or patients with variant translocations who are
    BCR-ABL positive in multiplex PCR (Cross et al 1994) are eligible
    as well
    • Pretreatment with Hydroxyurea for a duration of up to 6 months is
    permitted as is treatment with Imatinib for up to 3 months The
    investigator should notify the DMC requesting review of any
    patient who has received prior imatinib treatment for 6 or more
    weeks to ensure that the patient is not failing on imatinib.
    • Age ≥ 18 years old (no upper age limit)
    • WHO performance status 0-2
    • Normal serum levels ≥ LLN (lower limit of normal) of potassium,
    magnesium, total calcium corrected for serum albumin or
    phosphorus, or correctable to within normal limits with
    supplements, prior to the first dose of study medication
    • AST and ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to
    leukaemia
    • Alkaline phosphatase ≤ 2.5 x ULN unless considered due to
    leukaemia
    • Total bilirubin ≤ 1.5 x ULN, except know Mb. Gilbert
    • Serum lipase and amylase ≤ 1.5 x ULN
    • Serum creatinine ≤ 1.5 x ULN
    • Written informed consent prior to any study procedures being
    performed
    E.4Principal exclusion criteria
    Pretreatment with Hydroxyurea for a duration of > 6 months or >3 months with imatinib (the investigator should notify the DMC requesting review of any patient who has received prior imatinib treatment for 6 or more weeks to ensure that the patient is not failing on imatinib).
    • Contraindication to excipients in study medication
    • Known impaired cardiac function, including any of the following:
    • LVEF < 45%
    - Complete left bundle branch block
    - Right bundle branch block plus left anterior hemiblock,
    bifascicular block
    - Use of a ventricular-paced pacemaker
    - Congenital long QT syndrome
    - History of or presence of clinically significant ventricular or
    atrial tachyarrhythmias
    - Clinically significant resting bradycardia (<50 beats per
    minute)
    - QTcF>450 msec on screening ECG. If QTcF > 450 msec and
    electrolytes are not within normal ranges before Nilotinib
    dosing, electrolytes should be corrected and then the patient
    rescreened for QTcF criterion.
    - Myocardial infarction within 12 months prior to starting Nilotinib
    - Other clinical significant heart disease (e.g. unstable angina,
    congestive heart failure, uncontrolled hypertension)
    • History of acute (i.e., within 1 year of starting study medication) or
    chronic pancreatitis
    • Other concurrent uncontrolled medical conditions (e.g.,
    uncontrolled diabetes, active or uncontrolled infections, acute or
    chronic liver and renal disease) that could cause unacceptable
    safety risks or compromise compliance with the protocol
    • Impaired gastrointestinal function or disease that may alter the
    absorption of study drug (e.g., ulcerative disease, uncontrolled
    nausea, vomiting and diarrhea, malabsorption syndrome, small
    bowel resection or gastric by-pass surgery)
    • Concomitant medications with potential QT prolongation (see link
    for complete list: http://www.torsades.org/medical-pros/druglists/
    printable-drug-list.cfm)
    • Concomitant medications known to be strong inducers or
    inhibitors of CYP450 isoenzyme CYP3A4: see link for complete
    list (http://medicine.iupui.edu/flockhart/table.htm)
    • Patients who have undergone major surgery ≤ 2 weeks prior to
    starting study drug or who have not recovered from side effects of
    such therapy
    • Patients who are pregnant or breast feeding, or women of
    reproductive potential not employing an effective method of birth
    control. (Women of childbearing potential must have a negative
    serum pregnancy test within 14 days prior to administration of
    nilotinib). Post menopausal women must be amenorrheic for at
    least 12 months in order to be considered of non-childbearing
    potential. Female patients must agree to employ an effective
    barrier method of birth control throughout the study and for up to
    3 months following discontinuation of study drug
    • Treatment with any haematopoietic colony-stimulating growth
    factors (e.g., G-CSF, GM-CSF) ≤ 1 week prior to starting study
    drug
    • Known diagnosis of human immunodeficiency virus (HIV)
    infection (HIV testing is not mandatory)
    • Patients with a history of another primary malignancy that is
    currently clinically significant or currently requires active
    intervention
    • Patients unwilling or unable to comply with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is to evaluate the rate of MR at month 18 after the start of study medication. In this protocol a MR4.0 is defined as either (i) detectable disease ≤0.01% BCR-ABLIS or (ii) undetectable disease in cDNA with ≥10,000 ABL transcripts. MR4.5 is defined as either (i) detectable disease ≤0.0032% BCR-ABLIS or (ii) undetectable disease with in cDNA with ≥32,000 ABL transcripts.
    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 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 Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA331
    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
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.3Elderly (>=65 years) Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 743
    F.4.2.2In the whole clinical trial 806
    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 Decision2010-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-04
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