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    Summary
    EudraCT Number:2013-002466-39
    Sponsor's Protocol Code Number:CFTSp032
    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:2013-11-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-002466-39
    A.3Full title of the trial
    A randomised placebo-controlled trial of synchronous NIMorazole versus RADiotherapy alone in patients with locally advanced head and neck squamous cell carcinoma not suitable for synchronous chemotherapy or cetuximab.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NIMRAD: A randomised placebo-controlled trial of synchronous NIMorazole versus RADiotherapy alone in patients with locally advanced head and neck squamous cell carcinoma not suitable for synchronous chemotherapy or cetuximab
    A.3.2Name or abbreviated title of the trial where available
    NIMRAD (NIMorazole/placebo plus RADiotherapy in head and neck cancer)
    A.4.1Sponsor's protocol code numberCFTSp032
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01950689
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThe Christie NHS Foundation Trust
    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 organisationManchester Academic Health Sciences Centre Clinical Trials Coordination Unit (MAHSC-CTU)
    B.5.2Functional name of contact pointSuzanne Rowland
    B.5.3 Address:
    B.5.3.1Street AddressWilmslow Road
    B.5.3.2Town/ cityManchester
    B.5.3.3Post codeM20 4BX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01614463308
    B.5.5Fax number01614468148
    B.5.6E-mailsuzanne.rowland@christie.nhs.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/842
    D.3 Description of the IMP
    D.3.1Product nameNimorazole
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnimorazole
    D.3.9.1CAS number 6506-37-2
    D.3.9.3Other descriptive nameNimoral
    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 number475 to 525
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced head and neck squamous cell carcinoma (HNSCC)
    E.1.1.1Medical condition in easily understood language
    Head and Neck cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    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
    To examine whether patients with locally advanced head and neck squamous cell carcinoma unsuitable for either cisplatin chemotherapy or monoclonal antibody therapy benefit from the addition of nimorazole to standard definitive radiotherapy in terms of increased locoregional control without additional serious toxicity.
    E.2.2Secondary objectives of the trial
    To assess:
    •Overall survival
    •Cancer-specific survival
    •Disease-free survival
    •Cumulative incidence of loco-regional failure
    •Acute and late toxicity
    •Quality of life
    •Hypoxia signature prediction of nimorazole benefit
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational Research

    •Hypoxia gene signature: Translational research will investigate approaches that identify patients most likely to benefit from hypoxia modifying nimorazole. A diagnostic FFPE block will be collected at screening to qualify hypoxia gene signatures.
    •Radiogenomics: A blood sample (10ml EDTA) will be collected for a future radiogenomic study.

    Associated translation research within NIMRAD provides an opportunity to develop a biorepository of tissue and blood samples, which can be used for evaluation of signatures that predict benefit from hypoxia modification or risk of radiotherapy toxicity. Samples will be stored at the Paterson Institute for future analysis and will be covered by the Human Tissue Licence held by the Paterson Institute. Translational Research procedures will be detailed in a separate Translational Research Manual.

    This sub-study is integrated into the main NIMRAD protocol and included in the main patient information sheet and consent form. The archival tissue sample will be requested retrosepctively and the 10ml blood sample collected at screening will be taken at the same time as routine safety bloods wherever possible.
    E.3Principal inclusion criteria
    1. Histologically confirmed head and neck squamous cell carcinoma; all primary subsites except nasal cavity, oral cavity, nasopharynx and paranasal sinus (i.e. oropharynx, hypopharynx, larynx are allowed)
    2. Stage T3/T4 N0; any node +ve case including T1 node +ve; T2N0 base of tongue/hypopharynx
    3. Patients suitable for definitive radiotherapy. Block dissections may be performed pre-RT for N2/N3 disease
    4. WHO status 0-2
    5. Patient fit and able to undergo RT with nimorazole and be expected to complete treatment
    6. Absence of another disease or previous malignancy which is likely to interfere with the treatment or assessment of response.
    7. No evidence of distant metastases (M0)
    8. Unable to tolerate/ unlikely to benefit from platinum chemotherapy or monoclonal antibody therapy
    9. Women must be postmenopausal (no menstrual period for a minimum of 1 year) or have a negative serum pregnancy test on entry in the study (even if surgically sterilised).
    10. Greater than 18 years of age; no upper age limit
    11. Available for follow up within the United Kingdom
    12. Adequate renal and liver function - absolute neutrophil count ≥ 1.5 x 109/L, creatinine ≤ 2 x ULN, platelets > 100 x 109/L, bilirubin ≤ 2 x ULN, AST < 3 x ULN
    13. The capacity to understand the patient information sheet and the ability to provide written informed consent
    14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
    E.4Principal exclusion criteria
    1. Patients with T1N0 tumours or those within the nasopharynx, nasal cavity or sinus, oral cavity; T2N0 larynx and tonsil; unknown primary cancer
    2. Any prior chemotherapy in the last 6 months or RT within the planned radiation field
    3. Presence of any life threatening illness such as unstable angina or severe chronic obstructive pulmonary disease
    4. Mental disability or patient otherwise unable to give informed consent and/or complete patient questionnaires
    5. Hb <100 g/l (patients with anaemia may be transfused to bring Hb levels to >100 g/l.] within 1 week of treatment start)
    6. Peripheral neuropathy as assessed clinically (CTCAE ≥ Grade 2)
    7. Use of any investigational drug within 30 days prior to screening
    8. Severe and/or uncontrolled medical disease
    9. Any malabsorption syndrome (i.e. partial gastrectomy, small bowel resection, Crohn’s disease or ulcerative colitis)
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to examine whether patients with locally advanced HNSCC unsuitable for either cisplatin chemotherapy or monoclonal antibody therapy benefit from the addition of nimorazole to standard definitive radiotherapy in terms of increased locoregional control without additional serious toxicity.

    The primary outcome measure is loco-regional failure defined as the time from randomisation to the first of a local or nodal progression. Deaths without a preceeding loco-regional failure will be censored for this outcome measure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Recruitment to the trial is planned to be completed in 4 years. Time to event
    outcomes will be censored at 72 months from commencement of the study or 60 months from randomisation whichever is earlier. Thus potential follow-up will range from 24 months for the last patient recruited to 60 months for the first patient recruited.
    E.5.2Secondary end point(s)
    • Overall survival: Time from the date of randomisation to death from any cause.
    • Cancer-specific survival: Time from the date of randomisation to death from head and neck cancer.
    • Disease-free survival: Time from randomisation to the first progression (local, nodal or distant) or death from any cause.
    • Cumulative incidence of loco-regional failure. For this outcome death without preceding loco-regional failure will be treated as a competing risk i.e. it will be handled differently than in the primary outcome. It is anticipated that the trial interventions will not have differential impacts on the hazard of the competing risk and so the proposed primary outcome analysis should be the more powerful (Tai et al., 2011).
    • Acute and late toxicity (CTCAE v4).
    • Quality of life (QLC-Q30, H&N35, HADs) recorded at baseline, 6 weeks (i.e. end of radiotherapy) and then 6 months, 12 months, 24 months and 36 months from end of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Recruitment to the trial is planned to be completed in 4 years. Time to event
    outcomes will be censored at 72 months from commencement of the study or 60 months from randomisation whichever is earlier. Thus potential follow-up will range from 24 months for the last patient recruited to 60 months for the first patient recruited.
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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 concerned18
    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
    There will be a cut off point 24 months following the last treatment visit of the last patient. Study will stop at that time point regardless of whether patients have reached month 60 follow up visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    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: 118
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 352
    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 state470
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 470
    F.4.2.2In the whole clinical trial 470
    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)
    Nimorazole/placebo is administered with radiotherapy for a total of 6 weeks and so there is no provision of nimorazole/placebo after the radiotherapy has been completed.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation GMCLRN - Greater Manchester Comprehensive local research network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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