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    Summary
    EudraCT Number:2007-000208-34
    Sponsor's Protocol Code Number:CAMN107A2303
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-000208-34
    A.3Full title of the trial
    A phase III multi-center, open-label, randomized study of imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive Ph chronic myelogenous leukemia in chronic phase CML-CP
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberCAMN107A2303
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 FARMA
    B.1.3.4CountryItaly
    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 RoleComparator
    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 GLIVEC
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/1/01/198
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    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 INNImatinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.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/3/06/375
    D.3 Description of the IMP
    D.3.1Product nameNilotinib
    D.3.2Product code AMN107
    D.3.4Pharmaceutical form Modified-release 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.3.9.2Current sponsor codeAMN107
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    CHRONIC MYELOGENOUS LEUKEMIA CML-CP
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009013
    E.1.2Term Chronic myeloid leukaemia
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Primary objectives To compare the efficacy MMR rate at 12 months of nilotinib at 400mg BID with that of Gleevec/Glivec 400 mg QD in newly diagnosed, previously untreated Philadelphia chromosomepositive CML-CP patients. To compare the efficacy MMR rate at 12 months of nilotinib at 600 mg QD with that of Gleevec/Glivec 400 mg QD in newly diagnosed, previously untreated Philadelphia chromosomepositive CML-CP patients. The primary efficacy endpoint is the rate of major molecular response MMR at 12 months after the start of first study medication as measured by 8805; 3 log reduction of BCR-ABL transcript from standardized baseline or 8804; 0.1 BCR-ABL/control gene by international scale, measured by RQ-PCR.
    E.2.2Secondary objectives of the trial
    2. Key secondary objectives To compare the rate of 8805; 4 log reduction in BCR-ABL transcript levels from the standardized baseline established in the IRIS study or 8804; 0.01 BCR-ABL/control gene by international scale in nilotinib treatment arms to Gleevec/Glivec in adult patients with Ph CML in CP at 12 months. To compare the rate of complete cytogenetic response CCyR in nilotinib treatment arms to Gleevec/Glivec in adult patients with Ph CML in CP at 12 months.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inclusion criteria Male or female patients 8805; 18 years of age ECOG 0, 1, or 2. Patients with CML-CP within 6 months of diagnosis date of initial diagnosis is the date of first cytogenetic analysis . Standard conventional cytogenetic analysis must be done on bone marrow. FISH cannot be used Diagnosis of chronic myelogenous leukemia in chronic phase with cytogenetic confirmation of Philadelphia chromosome of 9;22 translocations presence of BCR-ABL a review of a minimum 20 metaphases is required Documented chronic phase CML will meet all the criteria defined by 15 blasts in peripheral blood and bone marrow 30 blasts plus promyelocytes in peripheral blood and bone marrow 20 basophils in the peripheral blood 8805; 100 x 109/L 8805; 100,000/mm3 platelets No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly Adequate end organ function as defined by total bilirubin 1.5 x ULN SGOT and SGPT 2.5 x ULN creatinine 1.5 x ULN Serum amylase and lipase 8804; 1.5 x ULN Alkaline phosphatase 8804; 2.5 x ULN unless considered tumor related. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before initiation of study drug. Patients must have the following laboratory values 8805; LLN lower limit of normal or corrected to within normal limits with supplements prior to the first dose of study medication. Potassium 8805; LLN Magnesium 8805; LLN Phosphorus 8805; LLN Ability to provide written informed consent prior to any study related screening procedures being performed.
    E.4Principal exclusion criteria
    Exclusion criteria Previously documented T315I mutations. Treatment with tyrosine kinase inhibitor s prior to study entry is not allowed, except in the following situation in emergent cases where the patient requires disease management while awaiting study start, commercial supplies of Gleevec/Glivec at any dose may be prescribed to the patient but for no longer than 2 weeks in duration. Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide Impaired cardiac function including any one of the following LVEF 45 or below the institutional lower limit of the normal range whichever is higher as determined by echocardiogram Inability to determine the QT interval on ECG Complete left bundle branch block Use of a ventricular-paced pacemaker Congenital long QT syndrome or a known family history of long QT syndrome. History of or presence of clinically significant ventricular or atrial tachyarrhythmias Clinically significant resting brachycardia 50 beats per minute QTc 450 msec on baseline ECG using the QTcF formula . If QTcF 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc Myocardial infarction within 12 months prior to starting study Other clinically significant heart disease e.g. unstable angina, congestive heart failure or uncontrolled hypertension . Known cytopathologically confirmed CNS infiltration in absence of suspicion of CNS involvement, lumbar puncture not required . Severe or uncontrolled medical conditions i.e. uncontrolled diabetes, active or uncontrolled infection . History of significant congenital or acquired bleeding disorder unrelated to cancer. Previous radiotherapy to 8805; 25 of the bone marrow. Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery. Treatment with other investigational agents within 30 days of Day 1. History of non-compliance to medical regimens or inability to grant consent. Use of therapeutic coumarin derivatives i.e., warfarin, acenocoumarol, phenprocoumon Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention Patients actively receiving therapy with strong CYP3A4 inhibitors e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. See link for complete list of these medications http //medicine.iupui.edu/flockhart/table.htm. Novartis must be contacted if a patient needs to be started on any of these drugs during study treatment. Impairment of gastrointestinal GI function or GI disease that may significantly alter the absorption of study drug e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis. Acute or chronic liver, pancreatic or severe renal disease considered unrelated to disease. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug Please see http //www.torsades.org/medical-pros/drug-lists/printable-drug list.cfm for a comprehensive list of agents that prolong the QT interval Patients who are a pregnant, b breast feeding, c of childbearing potential without a negative pregnancy test pls see protocol
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint The primary efficacy endpoint is the rate of major molecular response MMR at 12 months after the start of first study medication as measured by 8805; 3 log reduction of BCR-ABL transcript from standardized baseline or 8804; 0.1 BCR-ABL/control gene by international scale, measured by RQ-PCR.
    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 Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-03-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 318
    F.4.2.2In the whole clinical trial 861
    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 Decision2007-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
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