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    Summary
    EudraCT Number:2019-001709-25
    Sponsor's Protocol Code Number:CCR5119
    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:2020-01-14
    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 number2019-001709-25
    A.3Full title of the trial
    Randomised phase II trial testing efficacy of intra-tumoural hydrogen peroxide as a radiation sensitiser in patients with locally advanced/recurrent breast cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The KORTUC phase II Trial (Phase II trial testing efficacy of intra-tumoural hydrogen peroxide as a radiation sensitiser in patients with locally advanced and recurrent breast cancer)
    A.3.2Name or abbreviated title of the trial where available
    KORTUC phase II
    A.4.1Sponsor's protocol code numberCCR5119
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03946202
    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 SponsorThe Institute of Cancer Research
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Institute of Cancer Research
    B.5.2Functional name of contact pointResearch Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressDowns Road
    B.5.3.2Town/ citySutton
    B.5.3.3Post codeSM2 5PT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number020 8661 3460
    B.5.5Fax number020 8661 3107
    B.5.6E-maillone.gothard@icr.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 Yes
    D.2.1.1.1Trade name Hydrogen Peroxide Solution 3% BP 10 Vols
    D.2.1.1.2Name of the Marketing Authorisation holderThornton & Ross Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameHydrogen Peroxide Solution 3% BP 10 Vols
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHydrogen peroxide solution 3%
    D.3.9.1CAS number 7722-84-1
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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.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
    Patients with locally advanced/recurrent breast cancer
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    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
    Primary Objective:
    To test efficacy

    Primary Endpoint:
    Complete tumour response 12 months post-radiotherapy assessed by MR according to criteria outlined below and in Section 3.4 of the trial protocol

    MRI criteria for tumour response
    Complete response: No evidence of enhancement or tumour mass on MRI scan
    Partial response: Reduced tumour size but with residual mass and/or enhancement
    Stable disease: Stable tumour size and enhancement
    Progressive disease: Increased tumour size >20% and/or enhancement; New foci of tumour; Locoregional tumour spread
    E.2.2Secondary objectives of the trial
    Secondary Objective:
    To further characterise efficacy and safety

    Secondary Endpoints:
    • Proportion of patients withdrawing from study due to pain from intratumoural injections
    • Patients achieving pathological complete response following tumour resection prior to the 12-month MR assessment
    • Proportion of patients with partial response and stable disease
    • Planned/unplanned tumour excision and pathological response
    • Loco-regional recurrence, local progression-free survival and distant recurrence at 6, 12 and 24 months (clinical radiological assessment)
    • Overall survival at 6, 12 and 24 months
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Tumour biopsy and blood sampling sub-study
    2. MRI sub-study
    3. 3D super-resolution US sub-study

    Exploratory Objectives:
    Test for novel mechanisms of action of radiation sensitiser and biomarkers of response

    Exploratory endpoints:
    • Cell death and immune response markers before and after radiotherapy plus/minus drug, in blood and formalin-fixed paraffin embedded tumour tissue
    • Monitoring circulating tumor markers (e.g. circulating tumor DNA pre- and post-therapy) in blood
    • Early predictive biomarkers of response on DCE and DW-MRI pre- and post-RT plus/minus drug
    • Monitoring of abscopal responses in non-target lesions on routine imaging
    • Application of novel 3D super-resolution ultrasound (SRUS) imaging for radiotherapy response assessment in breast tumours (Subset of patients at RM, n=20)
    E.3Principal inclusion criteria
    • Patient age 18 years and over
    • Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases
    • Radical/high dose palliative radiotherapy required for lifetime control of local morbidities
    • Patient physically and mentally fit for radical/high dose palliative radiotherapy
    • Target tumour accessible for intra-tumoural injection
    • Patient suitable/compliant with MR protocol
    • At least one tumour diameter ≥30 mm and ≤150 mm measurable by ultrasound or MR imaging
    • Patients with predicted life expectancy of 12 months or more
    • Negative pregnancy test before start of radiotherapy in women of child bearing potential and an ability/willingness to protect against pregnancy for 3 months post-radiotherapy
    • Patient offers written informed consent
    E.4Principal exclusion criteria
    • Prior radiotherapy to the target area
    • Maximum diameter of target tumour <30 mm or >150mm measurable by ultrasound or MRI
    • Anatomical location and/or extent of disease difficult to access for safe intra-tumoural drug injections, for example by virtue of contiguous major blood vessels and/or brachial plexus
    • Concomitant chemotherapy or biological therapy except Herceptin, Pertuzumab and Denosumab (all endocrine therapies and bisphosphonates are allowed concomitantly; other cytotoxics and biological therapies apart from those mentioned above should be stopped 3 weeks prior to RT)
    • Pregnancy or nursing
    • Hypersensitivity to any of the KORTUC ingredients
    E.5 End points
    E.5.1Primary end point(s)
    Complete tumour response 12 months post-radiotherapy assessed by MRI according to criteria outlined in section 3.4 of the trial protocol and below


    MRI criteria for tumour response
    Complete response: No evidence of enhancement or tumour mass on MRI scan
    Partial response: Reduced tumour size but with residual mass and/or enhancement
    Stable disease: Stable tumour size and enhancement
    Progressive disease: Increased tumour size >20% and/or enhancement; New foci of tumour; Locoregional tumour spread
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please see above
    E.5.2Secondary end point(s)
    • Proportion of patients withdrawing from study due to pain from intratumoural injections recorded at 2-week post-RT visit
    • Patients achieving pathological complete response following tumour resection prior to the 12-month MR assessment will be included in a sensitivity analysis of the primary endpoint.
    • Proportion of patients with partial response and stable disease
    • Planned/unplanned tumour excision and pathological response recorded at post-RT follow-up visits
    • Loco-regional recurrence, local progression-free survival and distant recurrence at 6, 12 and 24 months (clinical and radiological assessment)
    • Overall survival at 6, 12 and 24 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see above
    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 No
    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
    Phase I "run in" study to confirm findings by collaborators in Japan in 12 UK patients.
    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 Yes
    E.8.1.1Randomised Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Radiotherapy without drug
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    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 years5
    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 years5
    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.1.1Number of subjects for this age range: 0
    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) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state184
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 184
    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)
    N/a. Patients continue standard follow up in accordance with policy at their local hospital.
    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 Decision2020-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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