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    Summary
    EudraCT Number:2009-014768-21
    Sponsor's Protocol Code Number:TUD-TEMDS1-042
    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:2010-01-05
    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 number2009-014768-21
    A.3Full title of the trial
    Treatment of MDS patients with single agent temsirolimus – a pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of MDS patients with single agent temsirolimus – a pilot study
    A.3.2Name or abbreviated title of the trial where available
    TEMDS
    A.4.1Sponsor's protocol code numberTUD-TEMDS1-042
    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 SponsorDresden Technical University
    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 supportDeutschen Krebshilfe
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportPfizer Pharma GmbH
    B.4.2CountryGibraltar
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum C. G. Carus an der TU Dresden Medizinische Klinik und Poliklinik I
    B.5.2Functional name of contact pointDr. M. Wermke
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstr. 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number+493514584673
    B.5.5Fax number+493514585389
    B.5.6E-mailmartin.wermke@uniklinikum-dresden.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 Torisel 25 mg/ml concentrate and solvent for the preparation of an infusion solution
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTEMSIROLIMUS
    D.3.9.1CAS number 162635-04-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.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
    Myelodysplastic Syndromes (MDS)
    (20 IPSS LOW+INT-1 and 20 IPSS INT-2+HIGH or proliferating CMML)
    E.1.1.1Medical condition in easily understood language
    Myelodysplastic Syndromes (MDS) with low and high risk
    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 10028533
    E.1.2Term Myelodysplastic syndrome
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the response of MDS patients to temsirolimus
    E.2.2Secondary objectives of the trial
    - Toxicity as measured by NCI CTCAE v3.0
    - Overall survival at 1 year
    - Progression-free-survival at 1 year
    - Rate of leukemic progression at 1 year
    - Overall hematological response rate at 1 year using modified IWG-criteria
    - Quality of life as measured by EORTC-QLQ30
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age greater/equal 18 years at the time of signing the informed consent form;

    2. Cytologically or histologically established diagnosis of de novo or therapy-related MDS according to the FAB-classification, either previously treated or untreated, presenting with:
    Group I (low-risk): Low- or INT-1 risk features according to IPSS and requiring at least 4 units of red blood cells within the last 8 weeks prior to study entry or presenting with neutropenia (<1 Gpt/l neutrophils)
    or
    Group II (high-risk): INT-2 or HIGH-risk IPSS refractory or intolerant to 5-Azacytidine.
    CMML patients of dysplastic phenotype (WBC < 13 Gpt/l) may be included in both arms according to IPSS. CMML patients showing proliferative phenotype (WBC >=13 Gpt/l) will be included in the high risk arm.

    3. Not eligible for an immediate allogeneic HSCT or conventional chemotherapy

    4. All previous MDS specific therapies (except supportive approaches like transfusions or antibiotics) must have been discontinued at least 4 weeks prior to study enrollment.

    5. ECOG performance status of <=3 at study entry (see Appendix 01).

    6. laboratory test results within these ranges:
    • Serum creatinine <= 177 µmo/l (<= 2.0 mg/dL)
    • Total bilirubin <= 3 x ULN
    • AST (SGOT) and ALT (SGPT) <= 3 x ULN
    • Total fasting cholesterol <= 9.1 mmol/l (350 mg/dl)
    • Fasting triglyceride level <= 4.5 mmol/l (400 mg/dl)
    • Platelets > 25 Gpt/l without transfusion support in patients with LOW- and
    INT- 1 Risk according to IPSS

    7. signed informed consent.
    E.4Principal exclusion criteria
    1. For Patients with LOW- or INT1-Risk according to IPSS: Thrombocytopenia below 25 Gpt/l (INT2- and HIGH-IPSS patients may be included irrespective of platelet count);

    2. known hypersensitivity to temsirolimus, sirolimus or any components of the infusion solution (dl-alpha-tocopherol, propylene glycol, anhydrous citric acid, polysorbate 80, polyethylene glycol 400, dehydrated alcohol);

    3. known hypersensitivity to macrolid antibiotics (because of structural similarities between this class of antibiotics and study medication);

    4. any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study;

    5. known positive for HIV or any other uncontrolled infection;

    6. presence of any other malignancy being not in complete remission for at least 3 years (previous chemotherapy for other malignancies is not an exclusion criteria);

    7. necessity of therapeutic anticoagulation (excluding low dose ASS);

    8. participation in an other clinical trial within the last 4 weeks;

    9. pregnant or breastfeeding females (lactating females must agree not to breast feed while on study);

    10. females of childbearing potential (FCBP) except those fulfilling the following criteria:
    - post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea
    with serum FSH > 40 U/ml);
    - post-surgery (6 weeks after bilateral ovarectomy with or without hysterectomy);
    - regular and correct use of contraceptives with a PEARL Index of < 1% (e.g.
    implants, depot formulations of hormones, oral contraceptives, intra uterine
    device – IUD);
    - sexual abstinence;
    - partner, who had vasectomy (confirmed by two negative analyses of semen);

    11. male patients, who do not agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 3 months following discontinuation from the study even if he has undergone a successful vasectomy;

    12. patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study;

    13. patients who are not likely to follow the trial protocol (lack of willigness to cooperate).

    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the overall hematological response rate (combination of CR, PR, marrow-CR and SD with HI) at 4 months using modified IWG-criteria

    E.5.1.1Timepoint(s) of evaluation of this end point
    1 . After 4 or 12 months of treatment
    E.5.2Secondary end point(s)
    Secondary Endpoints
    • Toxicity as measured by NCI CTCAE v3.0;
    • overall survival at 1 year;
    • progression-free survival at 1 year;
    • rate of leukemic progression at 1 year;
    • overall hematological response rate at 1 year using modified IWG-criteria;
    • quality of life as measured by EORTC-QLQ30.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every visit
    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) 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 concerned8
    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
    End of trial: last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years0
    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.1.2.1Number of subjects for this age range: 40
    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 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 2010-01-05. 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
    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 Decision2010-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-06-14
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