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    Summary
    EudraCT Number:2012-002029-31
    Sponsor's Protocol Code Number:CRUKD/12/002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-29
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-002029-31
    A.3Full title of the trial
    A Cancer Research UK Phase I/II study to compare [124I]mIBG PET/CT to [123I]mIBG imaging in patients with metastatic neuroblastoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An early trial of a new type of three-dimensional imaging called [124I]mIBG PET/CT in children with a type of cancer called neuroblastoma.
    A.3.2Name or abbreviated title of the trial where available
    A Phase I/II study of [124I]mIBG PET/CT in neuroblastoma
    A.4.1Sponsor's protocol code numberCRUKD/12/002
    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 SponsorCancer Research UK
    B.1.3.4CountryUnited Kingdom
    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 supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCancer Research UK
    B.5.2Functional name of contact pointCentre for Drug Development
    B.5.3 Address:
    B.5.3.1Street Address2 Redman Place
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeE20 1JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44207242 0200
    B.5.5Fax number+44203014 7633
    B.5.6E-mailregulatory@cancer.org.uk
    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 name[124I]mIBG Solution for Injection
    D.3.2Product code [124I]mIBG Solution for Injection
    D.3.4Pharmaceutical form Solution for injection
    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 INN[124I]mIBG
    D.3.9.2Current sponsor code[124I]mIBG
    D.3.9.3Other descriptive name[124I]meta-iodobenzylguanidine
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number18.5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 name[123I]mIBG
    D.3.2Product code [123I]mIBG
    D.3.4Pharmaceutical form Solution for injection
    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 INNIobenguane [123I] Injection
    D.3.9.1CAS number 76924-93-1
    D.3.9.2Current sponsor code123I-mIBG
    D.3.9.3Other descriptive nameIODINE (123I) IOBENGUANE
    D.3.9.4EV Substance CodeSUB12077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number74
    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
    newly diagnosed, relapsed or refractory metastatic neuroblastoma
    E.1.1.1Medical condition in easily understood language
    A type of childhood cancer which develops from early nerve tissue left behind from a baby's development in the womb.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    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
    To show that [124I]mIBG PET/CT can detect an equal or greater number of neuroblastoma lesions compared to conventional [123I]mIBG planar scintigraphy.
    E.2.2Secondary objectives of the trial
    1. To show that [124I]mIBG PET/CT can detect an equal or greater number of neuroblastoma lesions compared to conventional [123I]mIBG scintigraphy with 3D imaging by SPECT.

    2. Assessing the safety and toxicity profile of a single intravenous administration of [124I]mIBG.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically proven neuroblastoma with stage 4 disease as defined by the International Neuroblastoma Staging System (INSS).
    2. Aged ≥ 1 year at the time that written informed consent is given.
    3. Planned to undergo conventional [123I]mIBG planar scintigraphy for routine clinical care of neuroblastoma.
    4. Life expectancy of at least 12 weeks.
    5. World Health Organisation (WHO) performance status of 0, 1 or 2 for patients aged >12 years old or Lansky play scale score of ≥50% for patients aged ≤ 12 years old.
    6. Written (signed and dated) informed consent from patient ≥ 16 years old and/or parent or legal guardian for patients <16 years old and the patient be capable of co-operating with scanning requirements. (N.B. Written or verbal assent as appropriate should be sought from all patients who are under 16 years of age.)


    Additional inclusion criteria for biokinetic sub-study
    1. No requirement for general anaesthesia to undergo PET/CT scanning.
    2. Written (signed and dated) informed consent for the sub-study from patients aged ≥16 years or from the patient’s parent or guardian for patients aged <16 years. Capable of co-operating with the additional study PET/CT scans. (N.B. Written or verbal assent as appropriate should be sought from all patients who are under 16 years old.)


    Additional inclusion criteria for PET/MRI sub-study
    1. No requirement for general anaesthesia to undergo hybrid PET/MRI scanning.
    2. No previous experience of claustrophobia.
    3. Written (signed and dated) informed consent for the sub-study from patients aged 16 years or from the patient’s parent or guardian for patients aged <16 years. Capable of co-operating with the additional study PET/MRI scans. (N.B. Written or verbal assent as appropriate should be sought from all patients who are under 16 years of age.)

    Clinical Criteria for [124I]mIBG imaging:
    The patient must fulfil the following clinical criteria prior to administration of [124I]mIBG Solution for Injection due to the limited clinical experience with this novel radiotracer. These criteria will be confirmed by the Clinical Study Manager or Clinical Research Associate at the CDD prior to the authorisation for use of [124I]mIBG Solution for Injection for each patient:
    1. One or more metastatic disease foci observed on conventional [123I]mIBG planar scintigraphy. Disease foci will initially be identified by a Nuclear Medicine physician at the investigational site.
    2. ≥ 3kg at the time of the [124I]mIBG imaging to agree with the paediatric EANM guidelines.
    3. Haematological and biochemical indices within the ranges shown below.

    Values required for patients ≤16 years old
    Laboratory Test Value required
    Haemoglobin (Hb) ≥ 7.0 g/dl (N.B. transfusions will be allowed)
    Absolute neutrophil count (ANC) ≥ 0.20 x 10^9/L (N.B. G-CSF support will be allowed)
    Platelet count ≥ 10 x 10^9/L (N.B. transfusions will be allowed)
    Serum bilirubin ≤ 2.5 x upper limit of normal (ULN)
    ALT, AST, and/ or ALP ≤ 5 x ULN
    Calculated creatinine clearance using revised Schwartz formula ≥ 60 mL/min/1.73m^2

    Values required for patients >16 years old
    Laboratory Test Value required
    Haemoglobin (Hb) ≥ 8.0 g/dl (N.B. transfusions will be allowed)
    Absolute neutrophil count (ANC) ≥ 0.50 x 10^9/L (N.B. G-CSF support will be allowed)
    Platelet count ≥ 50 x 10^9/L (N.B. transfusions will be allowed)
    Serum bilirubin ≤ 2.5 x ULN
    ALT, AST, and/ or ALP ≤ 5 x ULN
    Calculated creatinine clearance using Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m^2

    3. Menarchal female patients must have a negative serum or urine pregnancy test before administration of [124I]mIBG Solution for Injection on Day 1 and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom, have an intra-uterine device and condom, diaphragm with spermicidal gel and condom) to be effective from Day 1 and for 7 days afterwards.
    4. Male patients with partners of child-bearing potential must agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] from Day 1 and for 7 days afterwards. Male patients with pregnant or lactating partners must agree to use barrier method contraception (e.g. condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
    E.4Principal exclusion criteria
    1. Treatment with any medications contra-indicated with mIBG scanning as listed in protocol. For example, decongestants containing pseudoephedrine, phenylpropalomine and phenylephrine, sympathomimetics, cocaine, antihypertensives, tricyclic antidepressants. These drugs should be stopped before administration as indicated in this list (usually for four biological half-lives to allow almost complete wash-out but refer to list). The Investigator should seek prospective approval of any planned variation from this list from the responsible Nuclear Medicine Consultant, CI and sponsor Medical Advisor.
    2. Stage 4S neuroblastoma as defined by the INSS.
    3. Any anti-cancer treatment planned between the routine [123I]mIBG imaging and the [124I]mIBG PET/CT scan on Day 2. Anti-cancer treatments can be started only after the Off-Study assessment on Day 3 to Day 7, see schedule of assessments in protocol. N.B. Patients should not be enrolled in the study if their participation will delay their subsequent treatment for neuroblastoma.
    4. Female patients who are pregnant or lactating.
    5. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
    6. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
    7. Patients with known hypersensitivity to mIBG.
    8. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical study.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the percentage of lesions detected as positive by [123I]mIBG planar scintigraphy which are also considered positive with [124I]mIBG PET/CT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    [124I]mIBG PET/CT scan to be performed 24 h (+3 h) after the administration of [124I]mIBG.
    E.5.2Secondary end point(s)
    1. Comparison of the percentage of lesions detected as positive by [123I]mIBG SPECT which are also considered positive with [124I]mIBG PET/CT.

    2. Determining the causality of each adverse event to [124I]mIBG and grading severity according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.02.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. [124I]mIBG PET/CT scan to be performed 24 h (+3 h) after the administration of [124I]mIBG.

    2. SAE and AE collection and monitoring commences from the time the patient gives their written consent to participate in the trial and continues for 7 days after the administration of [124I]mIBG. Follow-up of AEs with a causality of possible, probable or highly probable will continue until resolution, recovery to baseline, or stabilisation of these events unless the patient starts another anti-cancer therapy.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Imaging analysis (as compared to routine imaging modalities)
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    imaging study
    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 Information not present in EudraCT
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    The end of trial will be declared at the interim analysis point if results indicate futility or efficacy. If recruitment continues beyond the interim analysis, the end of trial will be declared following LPLV (Last Patient Last Visit).
    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 months11
    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 Yes
    F.1.1Number of subjects for this age range: 31
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 28
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    paediatrics
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state33
    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)
    standard treatment - participation in this trial will not affect or delay standard treatment for these patients
    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 Decision2013-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-15
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