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    Summary
    EudraCT Number:2011-001024-38
    Sponsor's Protocol Code Number:AIO-MAM-0110
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-09
    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 number2011-001024-38
    A.3Full title of the trial
    Randomisierte Phase II Studie zum Vergleich der Therapie Vinorelbin in Kombination mit dem mTOR-Inhibitor Everolimus vs. Vinorelbin Monotherapie in der Zweitlinienbehandlung von Patientinnen mit metastasiertem oder lokal fortgeschrittenem Her2/neu negativem Mammakarzinom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vinorelbine In Combination with the mTOR Inhibitor Everolimus vs Vinorelbine monotherapy in Advanced breast cancer
    A.3.2Name or abbreviated title of the trial where available
    VicTORia
    A.4.1Sponsor's protocol code numberAIO-MAM-0110
    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 SponsorAIO-Studien-gGmbH
    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 supportAIO-Studien-gGmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationiOMEDICO AG
    B.5.2Functional name of contact pointRiedt
    B.5.3 Address:
    B.5.3.1Street AddressHanferstr. 28
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79108
    B.5.3.4CountryGermany
    B.5.4Telephone number+4976115242153
    B.5.5Fax number+497611524280
    B.5.6E-mailtamara.riedt@iomedico.com
    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.3.4Pharmaceutical 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.3.9.3Other descriptive nameEVEROLIMUS
    D.3.9.4EV Substance CodeSUB02065MIG
    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.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
    local advanced metastatic breat cancer, second line therapy for patients who did not respond to treatment with anthracyclines or taxanes or are not suitable for such treatment
    E.1.1.1Medical condition in easily understood language
    breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary study goal is the evaluation of Progression-free survival (PFS)
    E.2.2Secondary objectives of the trial
    As secondary aim the following parameters will be determined for all participating patients:

    1. Safety and Tolerability
    - All adverse events
    - Serious adverse events
    - All side effects of the study medication
    - Serious side effects
    - Adverse events that lead to temporary or complete discontinuation of the study treatment
    - Rates and causes of death
    2. Rate of Progression Free Survival after 6 months (6 months PFSR)
    3. Overall survival (OS)
    4. Response rate (CR, PR)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    a. Establishment of a tumour tissue repository, Version 2.0, date 24.10.2011

    b. Determination of PI3KCA Status, Version 2.0, date 24.10.2011
    E.3Principal inclusion criteria
    1. Dated and signed patient informed consent before start of any in the protocol specified procedures
    2. Histologically or cytologically confirmed Her2/neu negative, metastatic or locally advanced breast cancer, including inoperable local relapse, with measureable or non-measureable lesions for which
    - a palliative second line chemotherapy is indicated. Anti-hormone palliative pretreatments do not count as separate treatment lines
    - treatment with anthracycline and/or taxanes has failed or is not suitable
    - and which cannot be adequately treated by operation or radiotherapy on its own
    3. An exclusive anti-hormone therapy is not sufficient for the patient
    4. ECOG Performance Status of 0-2
    5. Women, ≥ 18 years of age
    6. Life expectancy of at least 12 weeks.
    7. Adequate bone marrow, liver and renal function (according to SmPC of Vinorelbine, Afinitor®) based on laboratory assessments raised within 7 days prior to start of study treatment.
    - Haemoglobin ≥ 9.0 g/dl
    - Absolute neutrophil count (ANC) ≥ 2,000/mm³
    - Thrombocytes ≥ 100,000/µl
    - INR ≥ 2
    - Serum bilirubin ≤ 1.5x upper limit of normal ( in patients with known Gilbert syndrome, total bilirubin ≤ 3 x upper limit of normal, with direct bilirubin ≤ 1.5x upper limit of normal
    - ALT and AST ≤ 2.5x upper limit of normal (≤ 5x upper limit of normal in subjects with liver metastases)
    - Serum cholesterol ≤ 300 mg/dl or 7.75 mmol/l and triglycerides ≤ 2.5x upper limit of normal (with lipid lowering drugs permitted)
    - Serum creatinin ≤ 2x upper limit of normal
    8. Documentation of a negative pregnancy test in women of childbearing potential within 7 days prior to start of study. Sexual active pre-menopausal women are required to use adequate contraception throughout the duration of the study, except for oestrogen containing contraceptives.
    E.4Principal exclusion criteria
    1. Previous treatment with Vinorelbine or an inhibitor of mTOR
    2. Treatment with other study medication within 28 days before start of treatment
    3. Patients who have received prior radiotherapy to ≥ 25% of the bone marrow
    4. Other tumours in the previous 5 years with exception of an adequately treated basal cell carcinoma of the skin or a pre-invasive cervix carcinoma
    5. Simultaneous use of known CYP3A4 inducers (e.g. Phenytoin, Rifampicin) or inhibitors of this enzyme (e.g. Itraconazole, Ketoconazole), therefore also use of mistletoe, St John’s wort or grapefruit juice
    6. Patients to whom at least one of the conditions applies:
    - Substance abuse
    - medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results as judged by the investigator
    - Legal incapacity or limited legal capacity
    - Subjects who are unable to take oral medication
    - Any condition that could jeopardise the safety of the patient and their compliance in the study as judged by the investigator
    7. History of cardiac dysfunction including one of the following:
    - Myocardial infarction by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function
    - History of documented congestive heart failure (NYHA ≥ 3)
    - Documented cardiomyopathy
    8. Known HIV infection or chronic hepatitis B or C or history of hepatitis B or C
    9. Active clinically relevant infection (> grade 2 NCI-CTC Version 4.03)
    10. Clinical or radiological detection of CNS metastases
    11. Patients receiving concomitant immunosuppressive agents or chronic use of corticosteroids at the time of study entry except in cases outlined below:
    - topical applications (e.g. rash,) inhaled sprays, (e.g. obstructive airway diseases) eye drops or local injections (e.g. intra-articular) are allowed
    12. Active bleeding diathesis or an oral anti-vitamin K medication (except low-dose warfarin and aspirin or equivalent, as long as the INR ≤ 2)
    13. Kidney function disorder requiring dialysis
    14. Seriously impaired liver function (Child-Pugh, class C)
    15. Known hypersensitivity reaction to Vinorelbine or Everolimus
    16. Pregnant or breast-feeding subjects
    E.5 End points
    E.5.1Primary end point(s)
    evaluation of progression free survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    Q1 2017
    E.5.2Secondary end point(s)
    As secondary aim the following parameters will be determined for all participating patients:

    1. Safety and Tolerability
    - All adverse events
    - Serious adverse events
    - All side effects of the study medication
    - Serious side effects
    - Adverse events that lead to temporary or complete discontinuation
    of the study treatment
    - Rates and causes of death
    2. Rate of Progression Free Survival after 6 months (6 months PFSR)
    3. Overall survival (OS)
    4. Response rate (CR, PR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Q1 2017
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned40
    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 the trial is defined as last visit of the patient
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number 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: 139
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 139
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state139
    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 different from the expected normal treatment of that condition
    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 Decision2011-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-31
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