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    Summary
    EudraCT Number:2007-000597-22
    Sponsor's Protocol Code Number:GIMEMACML0307
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-05-09
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-000597-22
    A.3Full title of the trial
    The protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+ chronic myeloid leucemia (CML) in early chronic phase: a Phase II exploratory, multicenter study
    The protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+ chronic myeloid leucemia (CML) in early chronic phase: a Phase II exploratory, multicenter study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter study to evaluate drug response for the treatment of a white blood cell cancer in early chronic phase.
    A multicenter study to evaluate drug response for the treatment of a white blood cell cancer in early chronic phase.
    A.3.2Name or abbreviated title of the trial where available
    GIMEMA CML0307
    GIMEMA CML0307
    A.4.1Sponsor's protocol code numberGIMEMACML0307
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00481052
    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 SponsorG.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAssociazione Italiana contro le Leucemie (AIL)
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportNovartis Farma
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationG.I.M. EM. A.
    B.5.2Functional name of contact pointCentro Dati
    B.5.3 Address:
    B.5.3.1Street Addressvia Casilina, 5
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00182
    B.5.3.4CountryItaly
    B.5.4Telephone number06 70390526
    B.5.5Fax number06 70390540
    B.5.6E-mailgimema@gimema.it
    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 Yes
    D.2.1.1.1Trade name TASIGNA*112CPS 150MG
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Ph+ CML in early chronic phase
    Leucemia mieloide cronica Ph+ all`esordio
    E.1.1.1Medical condition in easily understood language
    Abnormal proliferation of the granulocyte, normal cells which are in the blood, they have a beginning in bone marrow (flexible tissue found in the interior of bones).
    Proliferazione abnorme dei granulociti, cellule normali del sangue che hanno origine nel midollo osseo (tessuto molle che si trova all`interno di alcune ossa).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10009013
    E.1.2Term 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 investigate the cytogenetic and molecular effects of the protein tyrosine kinase (PTK) inhibitor nilotinib in the treatment of early chronic phase Ph+ CML.
    To investigate the cytogenetic and molecular effects of the protein tyrosine kinase (PTK) inhibitor nilotinib in the treatment of early chronic phase Ph+ CML.
    E.2.2Secondary objectives of the trial
    To investigate in early CP Ph+ CML patients treated with nilotinib the clinical and the hematologic effects, the effect on bcr/abl point mutations, the kinetic of the response, the toxicity, the compliance to treatment and the dose density in the medium-long term.
    To investigate in early CP Ph+ CML patients treated with nilotinib the clinical and the hematologic effects,the effect on bcr/abl point mutations,the kinetic of the response,the toxicity,the compliance to treatment and the dose density in the medium-long term.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with a cytologic and cytogenetic confirmed diagnosis of Ph+ CML. 2. Age ≥ 18 years old 3. Early CP (within 6 months from diagnosis) 4. No prior treatment with any antileukemic drugs with the exception of Hydroxyurea (HU) and Anagrelide. 5. WHO performance status of ≤ 2 6. Normal serum level of potassium, total calcium corrected for serum albumin, magnesium and phosporus, or correctable with supplements 7. ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to leukaemia. 8. Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukemia. 9. Serum bilirubin ≤ 1.5 x ULN 10. Serum creatinine ≤ 1.5 x ULN 11. Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN. 12. Written informed consent prior to any study procedures being performed.
    1. Patients with a cytologic and cytogenetic confirmed diagnosis of Ph+ CML. 2. Age ≥ 18 years old 3. Early CP (within 6 months from diagnosis) 4. No prior treatment with any antileukemic drugs with the exception of Hydroxyurea (HU) and Anagrelide. 5. WHO performance status of ≤ 2 6. Normal serum level of potassium, total calcium corrected for serum albumin, magnesium and phosporus, or correctable with supplements 7. ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to leukaemia. 8. Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukemia. 9. Serum bilirubin ≤ 1.5 x ULN 10. Serum creatinine ≤ 1.5 x ULN 11. Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN. 12. Written informed consent prior to any study procedures being performed.
    E.4Principal exclusion criteria
    1. Impaired cardiac function, including LVEF < 45% as determined by MUGA scan or echocardiogram, uncontrolled congestive heart failure, uncontrolled hypertension 2. History of myocardial infarction within three months, or uncontrolled angina pectoris. 3. Significant electric heart abnormalities, including history or presence of significant ventricular or atrial tachyarrhythmias, congenital long QT syndrome and/or QTc > 450 msec on screening ECG (using the QTcF formula) . Patients with ventricular pacemakers and clinically significant bradycardias. Patients with heart blocks. 4. History of acute or chronic pancreatitis. 5. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) 6. Use of therapeutic coumarin derivates (i.e. warfarin, acenocoumarol, phenprocoumon). 7. Acute or chronic liver or renal disease considered unrelated to leukaemia 8. Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol 9. Patients who are currently receiving treatment with any of the medications listed in Appendix E and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix E have the potential to prolong QT, with the exception of HU and Anagrelide. 10. Patients who have received any antileukemic agents and treatments, including HSCT, with the exception of HU and Anagrelide. 11. Patients who have received any investigational drug ≤ 4 weeks. 12. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy. 13. Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of nilotinib). Post menopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and 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. 14. Treatment with any hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF) 1 week prior to starting study drug. 15. Patients who have received immunotherapy 1 week prior to starting study drug or who have not recovered from side effects of such therapy. 16. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory). 17. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. 18. Patients unwilling or unable to comply with the protocol.
    1. Impaired cardiac function, including LVEF &lt; 45% as determined by MUGA scan or echocardiogram, uncontrolled congestive heart failure, uncontrolled hypertension 2. History of myocardial infarction within three months, or uncontrolled angina pectoris. 3. Significant electric heart abnormalities, including history or presence of significant ventricular or atrial tachyarrhythmias, congenital long QT syndrome and/or QTc &gt; 450 msec on screening ECG (using the QTcF formula) . Patients with ventricular pacemakers and clinically significant bradycardias. Patients with heart blocks. 4. History of acute or chronic pancreatitis. 5. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) 6. Use of therapeutic coumarin derivates (i.e. warfarin, acenocoumarol, phenprocoumon). 7. Acute or chronic liver or renal disease considered unrelated to leukaemia 8. Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol 9. Patients who are currently receiving treatment with any of the medications listed in Appendix E and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix E have the potential to prolong QT, with the exception of HU and Anagrelide. 10. Patients who have received any antileukemic agents and treatments, including HSCT, with the exception of HU and Anagrelide. 11. Patients who have received any investigational drug ≤ 4 weeks. 12. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy. 13. Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of nilotinib). Post menopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and 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. 14. Treatment with any hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF) 1 week prior to starting study drug. 15. Patients who have received immunotherapy 1 week prior to starting study drug or who have not recovered from side effects of such therapy. 16. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory). 17. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. 18. Patients unwilling or unable to comply with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable is Complete cytogenetic response (CCgR ) rate at 1 year.
    Primary efficacy variable is Complete cytogenetic response (CCgR ) rate at 1 year.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 1 year from the last enrolled patient.
    After 1 year from the last enrolled patient
    E.5.2Secondary end point(s)
    To assess in early CP Ph pos patients treated with nilotinib the clinical, hematologic and molecular responses, the kinetic of the response, the toxicity and the compliance to treatment in the medium-long term..
    To assess in early CP Ph pos patients treated with nilotinib the clinical, hematologic and molecular responses, the kinetic of the response, the toxicity and the compliance to treatment in the medium-long term..
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    At the end of the study.
    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 No
    E.6.7Pharmacodynamic No
    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) 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number 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 concerned25
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months144
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state70
    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)
    Not applicable
    Not applicable.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Gruppo Italiano Malattie EMatologiche dell'Adulto
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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