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    Summary
    EudraCT Number:2012-000528-17
    Sponsor's Protocol Code Number:IAEA-HypoX
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-05
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2012-000528-17
    A.3Full title of the trial
    A randomized multicenter study of accelerated fractionated
    radiotherapy with or without the hypoxic radiosensitizer nimorazole in
    the treatment of squamous cell carcinoma of the head and neck
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter study of radiotherapy with or without nimorazle in the
    treatment of cancer in the Head and Neck
    A.4.1Sponsor's protocol code numberIAEA-HypoX
    A.5.4Other Identifiers
    Name:Clinical trial.gov no.Number:NCT01507467
    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 SponsorDepartment of Experimental Clinical Oncology
    B.1.3.4CountryDenmark
    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 supportIAEA
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportAzanta
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Experimental Clinical Oncology
    B.5.2Functional name of contact pointClinical Trial office
    B.5.3 Address:
    B.5.3.1Street Address44 Norrebrogade
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+45 -89492629
    B.5.5Fax number+45 -86197109
    B.5.6E-mailhassan@oncology.dk
    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 nameNimoral
    D.3.4Pharmaceutical form Tablet and powder for oral solution
    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 (INN)
    D.3.9.1CAS number 6506-37-2
    D.3.9.3Other descriptive nameNIMORAZOLE
    D.3.9.4EV Substance CodeSUB09298MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Squamous Cell Carcinoma of the Head and Neck region
    E.1.1.1Medical condition in easily understood language
    Cancer in the head and neck
    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
    The aim of the study is to determine the possible therapeutic gain of
    using nimorazole given as a hypoxic radiosensitizer in conjunction with
    accelerated fractionated radiotherapy of invasive squamous cell
    carcinoma of the larynx, pharynx and oral cavity, and evaluate the
    tolerance, compliance and toxicity of using nimorazole
    E.2.2Secondary objectives of the trial
    to investigate the predictive and prognostic impact of molecular
    biological markers of the tumors regarding hypoxia and HPV and
    describe their prevalence in relation to tumor characteristics such as
    size, site, pathological type and grade.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An associated programme and protocol for related translational
    research will be included. The focus will be on prognostic and
    predictive biomarkers for the response to the hypoxic radiosensitizer
    nimorazole. The analysis will be performed retrospectively, and the aim
    will be to identify biomarkers that can predict which patients will
    benefit from the use of nimorazole.
    E.3Principal inclusion criteria
    (1)Tumor classified as stage I-IV located in oropharynx, hypopharynx,
    larynx (not glottic stage I-II), or oral cavity according to the TNM
    classification.
    (2)Histopathological diagnosis of invasive squam¬ous cell carcinoma in
    the pri-mary tumor.
    (3)Age > 18 years.
    (4)Informed consent according to the Helsinki declaration and local
    regulations.
    (5)The patient must be candidate for external beam radical
    radiotherapy, and must be expected to accomplish the treatment.
    (6)Performance status 0-2 according to WHO criteria.
    (7) The patient should not have symptoms of peripheral neuropathy
    assessed by clinical examination.
    (8)Normal function of liver and kidney by routine laboratory examinations.
    (9)The patient must not be pregnant.
    E.4Principal exclusion criteria
    (1)Distant metastases.
    (2)The patient should not be in a state or condi¬tion that could be
    expected to influence the outcome of treat¬ment, or complicate the
    assessment or the treatment follow-up, or (apart from the present
    disease) reduce the life expectan¬cy.
    (3)Surgical excision (except biopsy), prior or planned (including
    elective neck dissection).
    (4)The existence of synchronous multiple malignancies (not
    leukoplakia).
    E.5 End points
    E.5.1Primary end point(s)
    - primary tumor control in T and N position (primary endpoint)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - primary tumor control in T and N position (primary endpoint)
    will be evaluated at the date of the first recurrence.
    E.5.2Secondary end point(s)
    - disease specific and overall survival
    - disease free survival
    - treatment related acute and late morbidity
    E.5.2.1Timepoint(s) of evaluation of this end point
    The three study end-points will be recorded at regular follow-up visits
    for at least 3 years after randomization or until death of the patient
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Accelerated Radiotherapy alone
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Egypt
    Estonia
    India
    Pakistan
    Slovenia
    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 trial will be open to recruitment for at least 3 years. One will
    consequently be able to perform the final analysis after 3.5 additional
    years of follow-up, or earlier if the number of events has been reached
    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 days0
    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 days0
    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: 600
    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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 600
    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)
    Follow up regularly in the treating center with proper medical care for the late side effects
    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 IAEA
    G.4.3.4Network Country Austria
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-03
    P. End of Trial
    P.End of Trial StatusOngoing
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