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    Summary
    EudraCT Number:2016-002053-38
    Sponsor's Protocol Code Number:MITIGATE-NeoBOMB1
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-16
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-002053-38
    A.3Full title of the trial
    A Phase I/IIa study to evaluate safety, biodistribution, dosimetry and preliminary diagnostic performance of 68Ga-NeoBOMB1 in patients with advanced TKI-treated GIST using positron-emission tomography/computer tomography (PET/CT).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase I/IIa study to evaluate safety and preliminary diagnostic performance of 68Ga-NeoBOMB1 in patients with advanced Tyrosine-kinase inhibitorstreated Gastrointestinal stromal tumours using positron-emission tomography/computer tomography (PET/CT).
    A.3.2Name or abbreviated title of the trial where available
    MITIGATE-NeoBOMB1
    A.4.1Sponsor's protocol code numberMITIGATE-NeoBOMB1
    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 SponsorMedical University Innsbruck
    B.1.3.4CountryAustria
    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 supportEuropean Union`s Seventh Framework Programme (FP7/2007-2013)
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University Innsbruck
    B.5.2Functional name of contact pointDepartment of nuclear medicine
    B.5.3 Address:
    B.5.3.1Street AddressAnichstraße 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number+4351250422651
    B.5.6E-mailirene.virgolini@i-med.ac.at
    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 No
    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 nameKit for the preparation of 68Ga-NeoBOMB1
    D.3.2Product code NeoBOMB1
    D.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    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 No
    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 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
    Gastrointestinal stromal tumours previously or currently under TKI-treatment including at least 50% TKI-resistant patients
    E.1.1.1Medical condition in easily understood language
    Gastrointestinal stromal tumours previously or currently under Tyrosine-kinase inhibitors treatment including at least 50% Tyrosine-kinase inhibitors-resistant patients
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I part:
    • Safety, tolerability
    • Human pharmacokinetics and dosimetry data to determine the organ doses and to identify potentially dose-limiting critical organs through PBPK modelling
    Phase I/IIa part:
    • Safety, tolerability
    • Preliminary targeting properties of 68Ga-NeoBOMB1 in advanced, GRP positive GIST tumours.

    E.2.2Secondary objectives of the trial
    • Targeting properties in comparison with standard imaging modalities such as FDG-PET or MRI
    • Qualitative comparison of targeting properties of 68Ga-NeoBOMB1 in resistant vs non-resistant tumour lesions in patients undergoing TKI treatment
    • Identification of target tissue and improved target volume definition for potential locoregional treatment (RFA or external beam)
    • To extrapolate absorbed tumour doses for potential application of 177Lu NeoBOMB1 (in the first 6 patients)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Understanding and provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures
    • Patients with histologically confirmed advanced GIST
    • Previous or current TKI treatment
    • A minimum of 50% of patients showing either 1st-, 2nd- or 3rd-line TKI-resistance documented either through RECIST 1.1 criteria, Choi-criteria or FDG-CT/PET and showing presence of at least one surgically untreatable primary or metastasis confirmed with either 18F-FDG PET/CT or structural imaging (CT, MRI) and a minimum of 25% non-resistant patients.
    • Karnofsky performance status > 70%
    • Age > 21 years.
    • Participating men must use a single barrier method for contraception for 1 month after completion of the trial starting at the day of application of 68Ga-NeoBOMB1.
    • Women of childbearing age must use two highly effective methods of contraception during the trial and 6 months after its completion if not in menopause (defined as onset of menopause without menstruation for over 1 year) or after hysterectomy.
    The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective:
    o Oral hormonal contraception (‘pill’) (as far as its efficacy is not expected to be impaired during the trial, e.g. with IMPs that cause vomiting and diarrhoea, adequate safety cannot be assumed)
    o Dermal hormonal contraception
    o Vaginal hormonal contraception (NuvaRing®)
    o Contraceptive plaster
    o Long-acting injectable contraceptives
    o Implants that release progesterone (Implanon®)
    o Tubal ligation (female sterilisation)
    o Intrauterine devices that release hormones (hormone spiral)
    o Double barrier methods
    o This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).
    o The regulations for contraception are derived from Guideline ICH E8 Chapter 3.2.2.1 Selection of subjects together with ICH M3 Note 4

    • Confirmed GRPR expression (phase II only)
    E.4Principal exclusion criteria
    • Renal insufficiency with an eGFR < 45 ml/min/1.72m2 or intolerance to any constituents of intravenous CT-contrast agents, preventing their administration
    • Higher than grade 2 hematotoxicity (CTC > 2)
    • Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and without evidence of recurrence for 5 years
    • Participation in any other investigational trial within 30 days of study entry with potential interactions regarding the study drugs or the underlying disease
    • Pregnancy, breast-feeding
    • Patients with concurrent illnesses that might preclude study completion or interfere with study results
    • Patients with bladder outflow obstruction or unmanageable urinary incontinence
    • Known or expected hypersensitivity to 68Gallium, Bombesin or to any of the excipients of NeoBOMB1.
    • Any condition that precludes raised arms position for prolonged imaging purposes.
    • Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical.
    • History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
    • Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.
    • Subjects with any kind of dependency on the investigator or is employed by the sponsor or investigator
    • Subjects held in an institution by legal or official order
    E.5 End points
    E.5.1Primary end point(s)
    Safety & Tolerability
    • Tolerability and safety of the administration of 68Ga-NeoBOMB1 in a diagnostic dose
    • Last follow-up visit (visit 3) for previous participant in first 3 participants

    Human Pharmacokinetics
    • Generation of decay corrected time activity curves from 68Ga-NeoBOMB1 PET/CT images in normal organs, tumour lesions.
    • Quantification of urinary excretion of 68Ga-NeoBOMB1
    • Calculation of half-life of 68Ga-NeoBOMB1 in blood

    Dosimetry
    • Generation of non-decay-corrected time activity curves and residence times from 68Ga-NeoBOMB1 PET/CT images in normal organs, tumour lesions
    • Calculation of absorbed doses and effective whole body dose of 68Ga-NeoBOMB1, also by PBPK modelling of 68Ga-NeoBOMB1

    Preliminary targeting properties
    • Description of 68Ga-NeoBOMB1 accumulation in tumour lesion (number of lesions, SUV value per lesion) and comparison with known tumour lesions.
    • Comparison of tumour targeting with immunhistopathology (at least in Phase I/IIa patients)

    E.5.1.1Timepoint(s) of evaluation of this end point
    end of the study
    E.5.2Secondary end point(s)
    • Number of tumour lesion detected by 68Ga-NeoBOMB1 in comparison with standard imaging modalities such as FDG-PET or MRI and comparison of resistant vs non-resistant patients
    • Target identification and volume definition based on 68Ga-NeoBOMB1 images for potential locoregional treatment (RFA or external beam)
    • Absorbed tumour doses of 177Lu NeoBOMB1 extrapolated from 68Ga-dosimetric data and definition of dose limiting organ for radionuclide therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of the study
    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 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) Yes
    E.7.1.1First administration to humans Yes
    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.8.2.4Number of treatment arms in the trial1
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    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 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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state12
    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 Decision2016-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-09
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