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    Summary
    EudraCT Number:2007-005116-12
    Sponsor's Protocol Code Number:CRAD001C2428
    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:2007-11-05
    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 number2007-005116-12
    A.3Full title of the trial
    Phase II study of the mTOR-Inhibitor EVEROLIMUS as
    maintenance therapy in patients aged over 60 years with Mantle
    Cell Lymphoma (MCL) after first, second, third or fourth line
    chemotherapy
    New title since Protocol Version 4.0
    Phase II study of the mTOR-Inhibitor EVEROLIMUS as
    maintenance therapy in patients aged over 60 years with Mantle
    Cell Lymphoma (MCL) after first, second, third or fourth line
    chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    CRAD001C2428
    A.4.1Sponsor's protocol code numberCRAD001C2428
    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 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 supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum rechts der Isar der Technischen Universität München
    B.5.2Functional name of contact pointUlrich Keller
    B.5.3 Address:
    B.5.3.1Street AddressIsmaningerstr. 22
    B.5.3.2Town/ cityMuenchen
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number00498941406472
    B.5.5Fax number00498941406479
    B.5.6E-mailsabine.ohlendorf@mri.tum.de
    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 Afinitor
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNEverolimus
    D.3.9.1CAS number 159351-69-6
    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) 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 Yes
    D.2.1.1.1Trade name Afinitor
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNEverolimus
    D.3.9.1CAS number 159351-69-6
    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) 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 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
    Strategies to prolong remission duration in elderly patients with MCL are urgently needed. The effects of Rapamycin derivates on MCL cells in vitro and the evolving in vivo data support the further investigation of RAD001 in this incurable disease
    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 investigate the efficacy (time to progression) and safety of a
    maintenance therapy with Everolimus in patients with MCL aged
    over 60 years or aged over 40 years but who are not eligible for high
    dose chemotherapy followed by autologous stem cell support or
    allogeneic stem cell transplantation
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with a proven history of mantle cell lymphoma
    2. Patients with achieved disease control after one to four lines
    of chemotherapy (complete response, partial response, stable
    disease) for mantle cell lymphoma.
    3. Patients must have been treated with a CHOP-like
    chemotherapy or a Fludarabine-containing regimen
    previously and Rituximab must have been used as part of the
    previous treatment.
    4. Age ≥ 60 years or patients ≥40 and <60 years of age who are
    not eligible for high dose chemotherapy followed by
    autologous stem cell support or allogeneic stem cell
    transplantation.
    5. Minimum of two weeks since any major surgery, completion
    of radiation, or completion of all prior systemic anticancer
    therapy (adequately recovered from the acute toxicities of
    any prior therapy).
    6. WHO performance status ≤ 2
    Adequate bone marrow function as shown by: ANC ≥ 1.5 x
    109/L, Platelets ≥ 100 x 109/L, Hgb > 9 g/dL
    8. Adequate liver function as shown by: serum bilirubin ≤ 1.5 xupper limit of normal (ULN), and serum transaminases
    activity ≤ 3 x ULN. With the exception of serum
    transaminases (< 5 x ULN) if the patient has liver metastases
    9. Life expectancy of at least 3 months
    10. Signed informed consent
    E.4Principal exclusion criteria
    - Prior treatment with any investigational drug within the
    preceding 4 weeks
    2. Chronic treatment with systemic steroids or another
    immunosuppressive agent except for Rituximab.
    3. Uncontrolled brain or leptomeningeal disease manifestation,
    including patients who continue to require glucocorticoids
    for brain or leptomeningeal disease manifestation
    4. Other malignancies within the past 3 years except for
    adequately treated carcinoma of the cervix or basal or
    squamous cell carcinomas of the skin.
    5. 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, psychiatric
    disease)
    6. A known history of HIV seropositivity
    7. History or serology indicating active or chronic Hepatitis B
    or C or detection of viral DNA (Hep. B or C) via PCR
    8. Impairment of gastrointestinal function or gastrointestinal
    disease that may significantly alter the absorption of
    EVEROLIMUS (e.g., ulcerative disease, uncontrolled
    nausea, vomiting, diarrhea, malabsorption syndrome or small
    bowel resection)
    9. Patients with an active, bleeding diathesis or on oral antivitamin
    K medication (except low dose coumarin)
    10. Previous organ transplantation.
    11. 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 EVEROLIMUS). Oral, implantable, orinjectable contraceptives may be affected by cytochrome
    P450 interactions, and are therefore not considered effective
    for this study. A highly effective methode of birth control is
    defined as those which results in a low failure rate (i.e. less
    than 1% per year) for example sexual abstinence or
    vasectomised partner.
    12. Patients who have received prior treatment with an mTor
    inhibitor.
    13. History of noncompliance to medical regimens
    14. Patients unwilling to or unable to comply with the protocol
    15. Patients with galactose intolerance, lack of lactase or
    malabsorption of glucose or galactose
    E.5 End points
    E.5.1Primary end point(s)
    Time to progression despite maintenance therapy with everolimus.
    Start of measurement is defined as last day of application of remission-inducing chemotherapy.
    E.5.2Secondary end point(s)
    To analyze toxicity and feasibility of a treatment with
    EVEROLIMUS in patients with MCL after first, second,
    third and fourth line chemotherapy
    • To analyze surrogate parameters involved in angiogenesis
    and cell-cycle regulation in patients with circulating MCL
    cells or bone marrow involvement (only in patients
    with circulating MCL cells or with bone marrow
    involvement)
    • To compare the duration of previous responses with the
    duration of responses in patients with maintenance therapy.
    • To analyze the conversion rate in MCL patients during
    maintenance therapy (improvement of partial to complete
    response, stable disease to partial or complete response).
    • To analyze the overall survival of patients with maintenance
    therapy.
    • To analyze Quality of life during maintenance therapy
    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 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) No
    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.8.4.1Number of sites anticipated in Member State concerned10
    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 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:
    disease progression
    • protocol violation
    • subject withdrew consent
    • lost to follow-up
    • administrative problems
    • death
    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 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 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 state25
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 25
    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 Decision2007-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-10-08
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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