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    Summary
    EudraCT Number:2010-021618-42
    Sponsor's Protocol Code Number:13603094
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-07-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-021618-42
    A.3Full title of the trial
    En fase II undersøgelse af oral vinorelbin i kombination med trastuzumab til 1. og 2. linie behandling af kvinder med metastaserende HER2 positiv brystkræft
    A.3.2Name or abbreviated title of the trial where available
    OVINTRA
    A.4.1Sponsor's protocol code number13603094
    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 SponsorVejle Hospital
    B.1.3.4CountryDenmark
    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 Yes
    D.2.1.1.1Trade name Navelbine
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Pharma Norden
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 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 INNVINORELBINE
    D.3.9.1CAS number 71486221
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 80
    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 Yes
    D.3.11.13.1Other medicinal product typecytostatica
    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 Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Metastatic breast cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10006198
    E.1.2Term Breast cancer recurrent
    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
    Formålet med dette fase II studie er at undersøge kombinationen af oral vinorelbin (Navalbine Oral®) 90 mg/m2 dag 1 + 8 med 3 ugers interval i kombination med trastuzumab (Herceptin®) til 1. og 2. linie behandling af kvinder med metastaserende HER2 positiv brystkræft.

    Det primære end point er
    • At evaluere Overall Respons Rate (ORR) for oral vinorelbin (Navalbine Oral®) i kombination med i.v. trastuzumab (Herceptin®) til 1. og 2. linie behandling af metastaserende HER2 positiv brystkræft.
    E.2.2Secondary objectives of the trial
    De sekundære end points er
    • At vurdere bivirkningsprofilen ved kombinationen.
    • At evaluere effektparametre ved kombinationen.
    o Progressionsfri overlevelse (PFS).
    o Samlet overlevelse (OS).
    o Varighed af respons (DR).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Kvinde, alder ≥ 18 år.
    • Performance Status (PS) 0-2. Forventet levetid på mere end 12 uger.
    • Histologisk verificeret brystkræft (adenokarcinom)
    • Primær tumor eller metastase er HER2 positiv med IHC3+ eller FISH+ (ratio ≥ 2.2).
    • Dokumenteret metastatisk brystkræft med mindst èn målbar læsion i henhold til RECIST 1.1 kriterierne. Alle solitære læsioner skal verificeres cytologisk/histologisk, hvis de repræsenterer den eneste evidens for sygdom.
    • Patienterne må have modtaget (neo-) adjuverende kemoterapi (taxaner, antracykliner og trastuzumab) samt 1. linie kemoterapi i kombination med trastuzumab for metastatisk sygdom.
    • Patienterne må have modtaget tidligere antihormonbehandling adjuverende og for metastatisk brystkræft.
    • Patienterne må gerne modtage strålebehandling, dog ikke mod læsioner der bruges ved responsevaluering.
    • Normal hjertefunktion, LVEF ≥ 50 % ved MUGA/EKKO.
    • Normal knoglemarvsfunktion: Hæmoglobin ≥ 6 mmol/l, ANC ≥1.5x109/l, Thombocytter ≥ 100x109/l.
    • Normal leverfunktion: Bilirubin ≤ 1.5 x øvre normalværdi, ALAT ≤ 2.5 x øvre normalværdi BASP ≤ 2.5 x øvre normalværdi (≤ 5 ved knoglemetastaser).
    • Normal nyrefunktion: Creatinin ≤ øvre normalværdi. Ved forhøjet creatinin skal målt/beregnet GFR ≥ 50 ml/min.
    • Fertile kvinder skal have negativ graviditetstest og anvende sikker antikonception under og 3 måneder efter behandlingen. Spiral uden hormon anses for sikker antikonception.
    • Patienten må ikke have psykiske eller sociale forhold der forhindrer behandling eller opfølgning.
    • Skriftligt og mundtligt informeret samtykke inden protokol relaterede undersøgelser.
    E.4Principal exclusion criteria
    • Lokalt tilbagefald eller kontralateral brystkræft uden anden disseminering.
    • Gravide eller ammende kvinder.
    • Kliniske symptomer, der tyder på CNS metastaser – inklusiv meningeal carcinomatose.
    • Malabsorptionssyndrom eller anden sygdom der påvirker den gastrointestinale funktion. Resektion af ventrikel eller tyndtarm, der kan påvirke absorption af oral vinorelbin.
    • Dysphagi eller andre forhold der gør, at patienten ikke kan indtage tabletter.
    • Alvorlig kongruerende medicinsk lidelse:
    o AMI inden for 12 mdr. eller ustabil angina.
    o Hjerteinkompensation NYHA III el. IV eller ikke kontrolleret hypertension (systolisk > 150 mm/hg og/eller diastolisk >100 mm/hg).
    o Alvorlig arytmi der kræver medicinering, med undtagelse af atrieflimmer og paroksystisk supraventrikulær takykardi.
    o Aktiv infektionssygdom, ikke kontrolleret diabetes eller hypercalcæmi.
    • Anden samtidig eksperimentel behandling
    • Samtidig antihormonbehandling for metastatisk brystkræft.
    • Kendt neuropati ≥ grad 2.
    • Anden tidligere malign lidelse inden for 5 år fraset non-melanom hudkræft og carcinoma in situ cervicis uteri.
    • Tidligere behandling med vincaalkaloid.
    • Tidligere alvorlige allergiske eller uventede reaktioner på behandling med trastuzumab.
    E.5 End points
    E.5.1Primary end point(s)
    Det primære end point er
    • At evaluere Overall Respons Rate (ORR) for oral vinorelbin (Navalbine Oral®) i kombination med i.v. trastuzumab (Herceptin®) til 1. og 2. linie behandling af metastaserende HER2 positiv brystkræft.
    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 Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Yes
    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 concerned4
    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
    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 months0
    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.1.1.1In 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 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 state55
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 55
    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 Decision2010-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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