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    Summary
    EudraCT Number:2015-003130-27
    Sponsor's Protocol Code Number:2015/2294
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-02-18
    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 number2015-003130-27
    A.3Full title of the trial
    An international multicenter phase II randomised trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study comparing two treatment strategies for metastatic neuroblastoma patients with poor response to induction chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    VERITAS
    A.4.1Sponsor's protocol code number2015/2294
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03165292
    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 SponsorGustave Roussy
    B.1.3.4CountryFrance
    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 organisationThe University of Birmingham
    B.5.2Functional name of contact pointJennifer Laidler
    B.5.3 Address:
    B.5.3.1Street AddressVincent Drive
    B.5.3.2Town/ cityBirmingham
    B.5.3.3Post codeB14 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01214143799
    B.5.5Fax number01214149520
    B.5.6E-mailveritas@trials.bham.ac.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 Information not present in EudraCT
    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 nameTopotecan
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    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 INNTopotecan
    D.3.9.1CAS number 123948-87-8
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 4
    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.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 Information not present in EudraCT
    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 nameThiotepa
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    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 INNThiotepa
    D.3.9.1CAS number 52-24-4
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 100
    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.IMP: 3
    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 Information not present in EudraCT
    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 name131I-MIBG
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 I 131
    D.3.9.1CAS number 77679-27-7
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number184 to 740
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic High Risk Neuroblastoma
    E.1.1.1Medical condition in easily understood language
    Patients with neuroblastoma which has spread to other parts of the body and has not responded well to initial chemotherapy
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate how well two different therapy regimens treat Very High Risk-NeuroBLastoma (VHR-NBL) by investigating the patients disease over time ("event-free survival")
    Each experimental treatment will be first evaluated to see how well the treatment works, then, if the treatments seem to treat the cancer successfully, the results of the different treatments will be compared.
    E.2.2Secondary objectives of the trial
    a - To investigate if the treatments prolong life ("overall survival") and to compare the life expectancy following the two treatments
    b - To investigate the side effects of the two treatments
    c - To investigate the disease response after the two study treatments and after the end of all treatment (i.e. after BuMel therapy)
    d - To investigate the differences in quality of life changes over time, following the two treatments.
    e - To evaluate the feasibility and document the logistical issues raised by 131I-mIBG and topotecan therapy given by multiple centres
    f - To evaluate the response to the two treatments over the time since the start of the treatments ("event free survival")
    g - To evaluate the response to the two treatments over the time since the diagnosis of disease ("event free survival")
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Metastatic neuroblastoma (NBL)
    2. Previously treated within the SIOPEN High Risk Neuroblastoma study or treated with the current standard treatment for very high risk neuroblastoma off-trial (Rapid COJEC induction chemotherapy)
    3. 131I-mIBG scintigraphy positive at diagnosis and after induction chemotherapy (pre BuMel evaluation).
    4. Metastatic response after induction chemotherapy lower than the SIOPEN High Risk Neuroblastoma trial criteria to be eligible for high dose chemotherapy (metastatic response worse than partial response (< PR) or SIOPEN score > 3)
    5. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use acceptable and appropriate contraception while on study drug and for one year after stopping the study drug. Acceptable contraception is listed in Appendix 12. Female patients who are lactating must agree to stop breast-feeding.
    6. Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.
    7. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
    E.4Principal exclusion criteria
    1. Parenchymal brain metastasis(es) (even one)
    2. Progressive disease at study entry
    3. Previous high-dose therapy and ASCR
    4. Performance status (Karnofsky or Lansky) <70%
    5. Patient having received other therapy for cancer treatment than those allowed as per the SIOPEN High Risk Neuroblastoma trial or as defined in the future frontline protocol (for HRNBL1 trial : after induction + 2 TVD)
    6. Impaired organ function (liver, kidney, heart, lungs) according to the following definitions
    o Shortening fraction <28%, or ejection fraction <55%, or clinical evidence of congestive heart failure or uncontrolled cardiac rhythm disturbance
    o Dyspnea at rest and/or pulse oximetry <95% in air.
    o ALT, Bilirubin > 2 ULN
    o Creatinine clearance and/or GFR < 60 ml/min/1.73m2 and serum creatinine ≥ 1.5 mg/dl
    7. Any uncontrolled inter-current illness or infection that in the investigator’s opinion would impair study participation
    8. Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines
    9. Patient allergic to peanut or soya
    10. Chronic inflammatory bowel disease and/or bowel obstruction
    11. Pregnant or breastfeeding women
    12. Known hypersensitivity to the active substance or to any of the excipients of study drugs
    13. Known hypersensitivity to dacarbazine
    14. Concomitant use with St John's Wort
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the 3 years Event-Free Survival from the date of randomisation into the VERITAS trial, considering as events:
    - disease progression or relapse
    - death from any cause
    - secondary malignancy.

    Patients without event are censored at the date of their last follow up evaluation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years from the date of randomisation
    E.5.2Secondary end point(s)
    a - Overall survival, defined as the time from randomisation to death from any cause.
    b - Adverse events, evaluated using NCI-CTCAE v5.0 toxicity grading system, reported by treatment phase and overall over the whole treatment duration (maximum grade). The stopping rule for toxicity will be based on the occurrence of adverse events leading to ventilation in an ICU and treatment-related deaths. These events will be specifically monitored over the first 6 months after randomisation.
    c - Disease response after BuMel and at the end of treatment
    d - For the Q-TWiST analysis: time spent with severe toxicity after randomisation and before progression/relapse (duration of hospitalisation will be used as a surrogate of time with toxicity); time spent without progression/relapse and without toxicity; and time from progression until death.
    e - Logistical issues raised by 131I-mIBG and topotecan or thiotepa therapy in a multicentre setting
    f - Event-Free Survival from the date of start of the consolidation phase
    g - Event-Free Survival from the date of the neuroblastoma diagnosis
    E.5.2.1Timepoint(s) of evaluation of this end point
    a- Time from randomisation to death
    b- Duration of treatment
    c- after BuMel and at end of treatment
    d- time with toxicity following randomisation; time from progression until death
    f and g - time to Event
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) 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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 is defined as the Last Patient Last Visit which will occur 3 years after the randomisation of the last patient in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days30
    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: 150
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 28
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 112
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    Written informed consent will be obtained from the patient or an approved guardian prior to performing any trial related procedure
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    On completing protocol defined treatment, their treating physician will discuss further treatment options with them and their family as per standard care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-14
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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