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    Summary
    EudraCT Number:2014-002800-25
    Sponsor's Protocol Code Number:N14ZTP
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-30
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-002800-25
    A.3Full title of the trial
    Zirconium-89 Trastuzumab tracer uptake in metastatic breast cancer: A pilot study.
    Zirkonium-89 Trastuzumab tracer opname in gemetastaseerd mammacarcinoom: Een pilot studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Distribution of Herceptin in patients with metastasised breast cancer with a Herceptin labelled radioactive tracer, visualised on PET/CT and PET images.
    Distributie van Herceptin in patienten met gemetastaseerd borstkanker met een aan Herceptin gebonden radioactieve stof zichtbaar op PET/CT en PET scan beelden.
    A.3.2Name or abbreviated title of the trial where available
    Zirconium-89 Trastuzumab tracer for metastatic breast cancer patients
    Zirkonium-89 Trastuzumab tracer voor gemetastaseerd mammacarcinoom
    A.4.1Sponsor's protocol code numberN14ZTP
    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 SponsorAntoni van Leeuwenhoek Hospital-Nuclear Medicine department
    B.1.3.4CountryNetherlands
    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 supportNKI-AVL
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNKI-AVL
    B.5.2Functional name of contact pointPrinciple Investigator
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205122282
    B.5.5Fax number00310205122290
    B.5.6E-mails.teixeira@nki.nl
    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 Trastuzumab
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration, Ltd., Welwyn Garden City-Hertfordshire, UK
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    D.3.11.5Radiopharmaceutical medicinal product Yes
    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 Yes
    D.3.11.13.1Other medicinal product type89-Zirconium
    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
    Patients with metastatic breast cancer, newly found on 18F-FDG PET/CT, with or without HER2/neu overexpression or amplification (n=5) of one of the biopsied lesions.
    E.1.1.1Medical condition in easily understood language
    Patients with breast cancer beyond the breast and lymph nodes.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Use 89Zr-Trastuzumab to characterise the in vivo biodistribution of Zr89-Trastuzumab using PET imaging in the primary tumour and distant metastases, and comparing patients with Her2/neu positive breast cancer to patients with HER2/neu negative breast cancer.
    E.2.2Secondary objectives of the trial
    Compare the 89Zirconium tracer uptake within the primary tumour and metastases with lesions visualised on the 18F-FDG PET/ CT. And, relate circulating HER2/neu (serum HER2) concentration to 89Zr-Trastuzumab uptake in the tumour.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histological confirmed breast cancer (5 with and 5 without HER2/neu overexpression or amplification), with a primary tumour and at least 1 distant metastatic lesion.

    Recent diagnostic 18F-FDG PET/CT (less than 1 month old) made at the NKI-AvL.
    E.4Principal exclusion criteria
    A medical condition (e.g. Li-Fraumeni) that would place the patient at unusual risk for development of new malignancies due to radiation.
    Concurrent use of investigational drug with unknown biodistribution.
    Present pregnancy, or the patient refuses to use an adequate contraception method if pre-menopausal.
    Known allergy for murine proteins (present in Trastuzumab).
    E.5 End points
    E.5.1Primary end point(s)
    Describe and quantify the 89Zr-Trastuzumab biodistribution in all patients in terms of heterogeneity, dose per volume (MBq/ml), percentage of injected dose per volume tissue (%ID/ml) and Standardised Uptake Values (SUVs) based on conventional PET/CT and MAMMI PET. Relate 89Zr-Trastuzumab tumour accumulation to 18F-FDG accumulation and Serum HER2 concentration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The main study endpoint is determined after all acquisitions are made and analysed, comparing the images of HER2/neu positive and breast cancer lesions. with the images of HER2/neu negative breast cancer lesions.
    E.5.2Secondary end point(s)
    A description of the relation between uptake patterns on 18F-FDG and 89Zr-Trastuzumab PET will be provided. Additionally, the variation of serum HER2 will be related to the Zr-89 Trastuzumab accumulation in the normal tissue and tumour lesions. These data again will provide mean and variation values in Her2/neu positive and negative tumours.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All endpoint will be analysed after acquisition of all images and obtaining all results from venous blood analyses.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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: 10
    F.1.3Elderly (>=65 years) No
    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 state10
    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)
    None.
    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 Decision2014-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-02
    P. End of Trial
    P.End of Trial StatusOngoing
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