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    The EU Clinical Trials Register currently displays   43854   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-000502-70
    Sponsor's Protocol Code Number:CAMN107ADE01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-12-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-000502-70
    A.3Full title of the trial
    An open-label phase I/II (proof of concept) trial of an combination of Nilotinib (AMN 107) and RAD001 in patients with acute myeloid leukemia
    A.3.2Name or abbreviated title of the trial where available
    CAMN107ADE01
    A.4.1Sponsor's protocol code numberCAMN107ADE01
    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 SponsorTechnical University of Munich
    B.1.3.4CountryGermany
    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 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAMN107
    D.3.2Product code AMN107-AAA.001
    D.3.4Pharmaceutical form Capsule*
    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 AMN107
    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) 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 Information not present in EudraCT
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEverolimus
    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 INNEverolimus
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEverolimus
    D.3.2Product code RAD001
    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 INNEverolimus
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    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
    To determine the rate of hematological response in adult patients with c-kit + AML. state the primary objective of the study
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the rate of hematological response in adult patients with c-kit + AML. state the primary objective of the study
    E.2.2Secondary objectives of the trial
    - To determine the duration of hematological response.
    - To evaluate overall survival.
    - To evaluate the safety profile of a combination treatment of Nilotinib and RAD001.
    - To evaluate improvement of symptomatic parameters.
    - To assess mTor, cKit and PDGF-R pathway activities during treatment as a
    predictive factor of response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with:
    De novo AML or secondary AML from MDS who are not candidates for
    myelosuppressive chemotherapy, or
    De novo AML or secondary AML from MDS who have relapsed disease or are
    refractory to standard therapy
    - Patients at least 18 years or older
    - Patients with WHO performance status of 0
    to 2 with a life expectancy under treatment of at least 3 months
    - Patients must have recovered from prior cytotoxic chemotherapy; treatment with
    Hydroxyurea or Ara-C is allowed until 24 hours to first administration of study drug.
    - Patients must have a serum creatinine of </= 1.5 x ULN, SGOT/SGPT </= 3 x ULN
    and total bilirubin </= 2.0 x ULN
    - Female patients of childbearing potential must have negative pregnancy test within
    7 days before initiation of study drug dosing. Postmenopausal women must be
    amenorrheic for at least 12 months to be considered of non-childbearing potential.
    Male and female patients of reproductive potential must agree to employ an
    effective barrier method of birth control throughout the study and for up to 6
    months following discontinuation of study drug.
    - Written informed consent obtained according to local guidelines.
    E.4Principal exclusion criteria
    - Patients with AML FAB M3.
    - Patients with an expected doubling of the peripheral blast within one week.
    - Patients who had prior allogeneic, syngeneic, or autologous bone marrow
    transplant or stem cell transplant less than 2 months previously.
    - 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 MUGA scan or echocardiogram
    Complete left bundle branch block
    Use of a cardiac pacemaker
    ST depression of > 1mm in 2 or more leads and/or T wave inversions in 2 or
    more contiguous leads
    Congenital long QT syndrome
    History of or presence of significant ventricular or atrial tachyarrhythmias
    Clinically significant resting bradycardia (< 50 beats per minute)
    QTc > 450 msec on screening ECG (using the QTcF formula)
    Right bundle branch block plus left anterior hemiblock, bifascicular block
    Myocardial infarction within 12 months prior to starting Nilotinib
    Unstable angina diagnosed or treated during the past 12 months
    Other clinically significant heart disease (e.g., congestive heart failure,
    uncontrolled hypertension, history of labile hypertension, or history of poor
    compliance with an antihypertensive regimen)
    - Female patients who are pregnant or breast feeding, or adults of childbearing age
    not employing an effective method of birth control.
    - Concurrent severe and/or uncontrolled medical or psychiatric condition which may
    interfere with the completion of the study.
    - Patients who had more than 2 prior regimens for their current relapsed or current
    primary refractory disease
    - Patients with uncontrolled active infection.
    - Patient with any pulmonary infiltrate on the baseline chest X-ray known to be new
    in the previous 4 weeks. Prior treatment with any investigational drug within the
    preceding 4 weeks
    - Chronic treatment with systemic steroids or another immunosuppressive agent
    - Uncontrolled brain or leptomeningeal metastases, including patients who continue
    to require glucocorticoids for brain or leptomeningeal metastases
    - Other malignancies within the past 3 years except for adequately treated
    carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
    - Other concurrent severe and/or uncontrolled medical disease which could
    compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled
    hypertension, severe infection, severe malnutrition, unstable angina, or congestive
    heart failure - New York Heart Association Class III or IV, ventricular arrhythmias
    active ischemic heart disease, myocardial infarction within six months, chronic liver
    or renal disease, active upper GI tract ulceration)
    - A known history of HIV seropositivity
    - Impairment of gastrointestinal function or gastrointestinal disease that may
    significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled
    nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
    - Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
    (except low dose coumarin)
    - Women who are pregnant or breast feeding, or women able to conceive and
    unwilling to practice an effective method of birth control. (Women of childbearing
    potential must have a negative urine or serum pregnancy test within 7 days prior
    to administration of RAD001). Oral, implantable, or injectable contraceptives may be
    affected by cytochrome P450 interactions, and are therefore not considered
    effective for this study.
    - Patients who have received prior treatment with an mTor inhibitor.
    - History of noncompliance to medical regimens
    - Patients unwilling to or unable to comply with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    To determine the rate of hematological response in adult patients with c-kit + AML. state the primary objective 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 Information not present in EudraCT
    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
    Reasons that a patient may discontinue participation in a clinical study are considered to constitute one of the following:
    1. Serious adverse event(s)
    2. abnormal test procedure result(s)
    3. disease progression
    4. protocol violation
    5. subject withdrew consent
    6. lost to follow-up
    7. administrative problems
    8. death

    Follow Up every 3 month for 3 years.
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 2007-12-14. Yes
    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 state40
    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)
    provided in the protocol, 3 years follow up
    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 Decision2007-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-06-29
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