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    The EU Clinical Trials Register currently displays   43855   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-003977-10
    Sponsor's Protocol Code Number:HNBE-03-02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-06-21
    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 number2004-003977-10
    A.3Full title of the trial
    A randomized trial comparing preservation of function status after either MedPulser Electroporation with intratumoral bleomycin therapy or surgery in patients with locally recurrent or second primary squamous cell carcinoma of the base of tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx that have failed primary curative therapy
    A.4.1Sponsor's protocol code numberHNBE-03-02
    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 SponsorGenetronics / inovio Biomedical
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisation
    B.5.2Functional name of contact point
    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.2.1.1.1Trade name Bleo-Kyowa
    D.2.1.1.2Name of the Marketing Authorisation holderKyowa Hakko (UK) Ltd
    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 nameBleomycin Sulfate
    D.3.2Product code EPT/Bleomycin
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBleomycin Sulfate
    D.3.9.2Current sponsor codeEPT/Bleomycin
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.2.1.1.1Trade name Bleomycin 15,000 IU Powder for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderMayne Pharma Plc
    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 nameBleomycin Sulfate
    D.3.2Product code EPT/Bleomycin
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBleomycin Sulfate
    D.3.9.2Current sponsor codeEPT/Bleomycin
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Patients with locally recurrent or second primary SCC of the base of
    tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx that have failed primary
    curative therapy in whom surgical resection is seen as an option for disease control
    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
    To compare function status at 4 months after treatment with bleomycin-EPT or surgery in patients with locally recurrent or second primary SCC of the base of tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx that have failed primary curative therapy and in
    whom surgical resection is seen as an option for disease control.
    E.2.2Secondary objectives of the trial
    - To evaluate local tumor recurrence, disease free survival and overall survival rates through 2
    years after bleomycin-EPT or surgery treatment.
    - To evaluate safety through 6 months after the study treatment.
    - To evaluate the durability of function status outcomes at 8 months after bleomycin-EPT or
    surgery treatment.
    - To evaluate pharmacoeconomic parameters through 8 months after bleomycin-EPT or
    surgery treatment.
    - To characterize bleomycin systemic absorption and plasma pharmacokinetics following IT
    bleomycin-EPT administration.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. The presence of SCC of the base of tongue, posterior lateral pharyngeal wall,
    hypopharynx, or larynx must be confirmed by histological examination of a tissue
    sample (e.g., biopsy) obtained within 1 month of the patient receiving the study
    treatment.
    2. Recurrent or second primary disease in patients where surgical resection is seen as
    an option for disease control.
    3. The length of the longest diameter of the study lesion must be < 5 cm and the
    calculated treatment volume must be < 60.0 cm3 (tumor volume plus a 0.5 cm margin
    around the tumor) for the study lesion [where treatment volume = 0.5 (A+1) (B+1)^2
    and where A = length of the longest diameter (cm), B = the next longest diameter
    perpendicular to “A” (cm)].
    4. Tumor burden must be completely encompassed by surgery or bleomycin-EPT.
    5. Age: 18 years or older.
    6. Men and women of childbearing potential must use physician approved
    contraceptive methods for 7 days following bleomycin-EPT.
    7. Hematopoietic status:
    ANC > 1000/uL
    Platelets > 75,000/mm3
    PT: INR ≤ 1.5 (correctable with Vitamin K injection)
    8. Blood Chemistry status:
    Transaminases < 3 times upper limit of normal
    Total Bilirubin < 2.5 mg/dL
    Creatinine < 2.5mg/dL
    9. A written Informed Consent Form must be signed prior to the patient receiving
    any study procedures or treatments.
    E.4Principal exclusion criteria
    1. Patients with tumors suspected of involving a 50% or greater encasement of a
    blood vessel as measured by MRI or CT scan.
    2. Patients with tumors having bone invasion.
    3. Patients with any metallic implants in the treatment field.
    4. Patients with hypersensitivity to bleomycin.
    5. Patients who have received or will exceed a total lifetime dose of bleomycin
    greater than 400 Units.
    6. Patients deemed unsuitable for general anesthesia.
    7. Patients with a significant history of emphysema or pulmonary fibrosis.
    8. Patients with indwelling cardiac pacemakers who cannot tolerate a period with
    pacemaker turned off.
    9. Patients with a history of uncontrolled cardiac arrhythmia.
    10. Women who are pregnant, or are nursing. Women of childbearing potential must
    have a negative βHCG test within 7 days of study treatment.
    11. Radiation therapy to the treatment area within 8 weeks of study treatment.
    12. Chemotherapy or other cancer therapy (e.g., surgery, cryotherapy, etc.) to the
    treatment area within 4 weeks of study treatment.
    13. Patients participating in a clinical study for an investigational drug or device
    within 4 weeks prior to the study treatment.
    14. Patients previously randomized to this study.
    E.5 End points
    E.5.1Primary end point(s)
    Function status, evaluated at 4 months after initiation of treatment by the validated, clinicianrated
    disease specific, head and neck Performance Status Scale (PSSHN), will be the primary
    efficacy endpoint to determine clinical benefit. The PSSHN will be administered at each
    investigational site by a clinician or health professional trained according to the standard
    recommendations for administering the PSSHN.
    Clinical benefit will be defined as at least a 20% difference between treatments for
    the proportion of patients that improved or had no change from baseline in at least
    one of the discrete PSSHN function status scales (i.e., functional performance related
    to normalcy of diet, eating in public and understandability of speech). No change is
    defined as patients who did not change from baseline in understandability of speech
    or eating in public by one level (25 points) or no more than two levels (20 points) for
    normalcy of diet.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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
    Surgery
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    - in the MS concerned: clinical evaluation after treatment: week one (1) and every one (1) month for the first (1st) year, every two (2) months for the second (2nd) year.
    - in all countries involved in the trial: clinical evaluation after treatment: week one (1) and every one (1) month for the first (1st) year, every two (2) months for the second (2nd) year.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-06-21. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 99
    F.4.2.2In the whole clinical trial 256
    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 Decision2005-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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