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    Summary
    EudraCT Number:2013-001296-20
    Sponsor's Protocol Code Number:MITOCET
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-12-02
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-001296-20
    A.3Full title of the trial
    Randomized Phase IV Trial to Compare Cetuximab with Concomitant Radiation Therapy with Concomitant
    Mitomycin-C and 5-FU with Radiation Therapy for Locally Advanced Squamous Cell Carcinomas of The Head and Neck
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized Phase IV Trial to Compare Cetuximab with Concomitant Radiation Therapy with Concomitant
    Mitomycin-C and 5-FU with Radiation Therapy for Locally Advanced Squamous Cell Carcinomas of The Head and Neck
    Randomisierte Phase IV Studie zum Vergleich von Cetuximab mit begleitender Radiotherapie mit Mitomycin C und 5-Fluorouracil mit begleitender Radiotherapie bei lokal fortgeschrittenem Plattenepithelkarzinom im Kopf-Halsbereich
    A.3.2Name or abbreviated title of the trial where available
    MITOCET
    A.4.1Sponsor's protocol code numberMITOCET
    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 SponsorMedizinische Universität Innsbruck
    B.1.3.4CountryAustria
    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 supportMerck KGaA
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Innsbruck
    B.5.2Functional name of contact pointOE Clinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressAnichstraße 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number0043512900370086
    B.5.5Fax number0043512900373086
    B.5.6E-mailctc@i-med.ac.at
    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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameErbitux
    D.3.4Pharmaceutical form 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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.2Current sponsor codeErbitux
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.2.1.1.1Trade name 5- Fluorouracil
    D.2.1.1.2Name of the Marketing Authorisation holderEBEWE Pharma Ges.m.b.H. Nfg. KG
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 name5-Fluorouracil "Ebewe"
    D.3.4Pharmaceutical form 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 INNFluorouracil
    D.3.9.2Current sponsor code5-FU
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.2.1.1.1Trade name Mitomycin C “Kyowa”
    D.2.1.1.2Name of the Marketing Authorisation holderEBEWE Pharma Ges.m.b.H.Nf
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameMitomycin C “Kyowa”
    D.3.4Pharmaceutical form Powder 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 INNMitomycin
    D.3.9.2Current sponsor codeMitomycin
    D.3.9.3Other descriptive nameMITOMYCIN-C J.P.
    D.3.9.4EV Substance CodeSUB21202
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Locally advanced squamous cell carcinomas of head and neck
    E.1.1.1Medical condition in easily understood language
    Cancer of 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 primary objective of the study is to demonstrate that Cetuximab combined with radiation therapy has a higher life quality compared to 5-FU/MMC plus radiation therapy, because of decreased side effects.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study are to evaluate:
    - Efficacy of Cetuximab plus radiation therapy
    - Equality in therapy of Cetuximab plus radiation therapy versus 5-FU/MMC plus radiation therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • must have a non non-resectable cancer of head and neck

    • must have pathologically proven squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, larynx or cancer of unknown primary site.
    • must have stage III or IV disease with an expected survival of ≥ 12 months with node status of N0-N2
    • must be medically suitable to withstand a course of definitive radiation therapy and concomitant chemotherapy or antibody-therapy
    • must have a Karnofsky performance status (KPS) of ≥ 70
    • must be age between ≥18 and ≤80 years of age
    • must have the following laboratory values:
    Neutrophilcount ≥ 100/uL ≥ 1.5 x 109/L
    Platelet count ≥ 80,000/uL ≥ 100 x 1012 /L
    Bilirubin ≤ 1.5 mg/dL ≤ 25µ M/L
    SGOT ≤ 2 x the upper limit of normal ≤ 2 x the upper limit of normal
    SGPT ≤ 2 x the upper limit of normal ≤ 2 x the upper limit of normal
    Serum creatinine or estimated creatinine clearance ≤1.5mg/Dl ≥ 50 mL/min ≤ 133µ M/L ≥ 50 mL/min
    Serum calcium Within normal limits Within normal limits
    • must be disease free from a previously treated malignancy for greater more than three years
    • a history of a previous basal basal cell carcinoma of the skin or pre-invasiv carcinoma of the cervix are no exclusion criteria
    • must provide signed and dated written informed consent
    • Female subjects of childbearing potential must:
    - Understand that the study medication could have an expected teratogenic risk
    - Agree to use, and be able to comply with, effective contraception without inter-ruption, 4 weeks before starting study drug, throughout study drug therapy (in-cluding dose interruptions) and for 3 months after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception*
    Implant
    Levonorgestrel-releasing intrauterine system (IUS)
    Medroxyprogesterone acetate depot
    Tubal sterilisation
    Sexual intercourse with a vasectomised male partner only; vasec-tomy must be confirmed by two negative semen analyses
    Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
    * Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception.

    - Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
    - Agree to have a medically supervised pregnancy test every 4 weeks including 3 months after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence

    • Male subjects must:
    - Agree to use condoms throughout study drug therapy, during any dose interruption and for 3 months after cessation of study therapy if their partner is of childbearing potential and has no contraception.
    - Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
    E.4Principal exclusion criteria
    • have evidence of distant metastatic disease
    • have received prior systemic chemotherapy within the last three years
    • have undergone previous surgery for the tumour under study, other than biopsy and debulking of squamous cell carcinoma arising in the larynx
    • have received prior radiation therapy to the head and neck
    • be receiving radiation therapy as part of a postoperative regimen follow-ing primary surgical resection
    • be pregnant or breast feeding
    • have received prior Cetuximab or murine monoclonal antibody therapy
    • have received prior Mitomycin-C and 5-FU
    • have actual hemorrhages
    • have stomatitis, ulcerations in the mouth and the gastrointestinal tract
    • have actual severe diarrhea
    • have severe infectious diseases (e.g. Hepatitis A, B, C, D and/or HIV)
    • have coagulation disorders
    • have active vaccination
    • have medical or psychological condition that would not permit the patient to complete the trial or sign informed consent
    • have an active participation in another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to examine the quality of life, based on differences in acute and late side effects.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 months
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are:
    • to determine the differences in response rates.
    • to examine differences in the rate of locoregional disease control, maintained for one year.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    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 Decision2013-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-04-19
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