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    The EU Clinical Trials Register currently displays   43857   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:2005-005170-80
    Sponsor's Protocol Code Number:VB4-845-01-IIIA
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-08-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2005-005170-80
    A.3Full title of the trial
    A RANDOMIZED, MULTICENTRE THERAPEUTIC CONFIRMATORY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PROXINIUM™ PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE IN PATIENTS WITH ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK WHO HAVE RECEIVED AT LEAST ONE ANTI-CANCER TREATMENT REGIMEN FOR ADVANCED DISEASE
    A.4.1Sponsor's protocol code numberVB4-845-01-IIIA
    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 SponsorViventia Biotech Inc.
    B.1.3.4CountryCanada
    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 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/3/05/290
    D.3 Description of the IMP
    D.3.1Product nameProxinium™ (Proxinium)
    D.3.2Product code VB4-845
    D.3.4Pharmaceutical form Solution 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 INNProxinium™ (Proxinium)
    D.3.9.2Current sponsor codeVB4-845
    D.3.9.3Other descriptive name4D5MOCB-ETA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant fusion protein
    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
    Advanced Ep-CAM Positive Squamous Cell Carcinoma of the Head and Neck
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To compare the overall survival time associated with intratumourally injected Proxinium plus BSC versus BSC in patients with advanced SCCHN who have received at least 1 anti-cancer treatment regimen for advanced disease.
    E.2.2Secondary objectives of the trial
    1. To compare locoregional tumour control, as assessed by the locoregional response rate, for patients treated with Proxinium plus BSC versus BSC.
    2. To compare the local progression-free survival for patients treated with Proxinium plus BSC versus BSC.
    3. To compare the symptomatic benefit for patients treated with Proxinium plus BSC versus BSC.
    4. To compare the safety profile for patients treated with Proxinium plus BSC versus BSC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient must be 18 years of age or older.
    2. The patient must be able to comply with scheduled study assessments and in-person visits and must have an ECOG performance status of 0, 1, 2 or 3.
    3. The patient must have a life expectancy of at least 12 weeks.
    4. The patient must have histologically-confirmed SCCHN.
    5. The patient must have immunohistochemically-confirmed Ep-CAM-positive SCCHN.
    6. The patient must have received curative intent therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy).
    7. The patient must have documented advanced disease following treatment for their primary disease (ie, persistent or recurrent disease or second primary tumour).
    8. The patient’s advanced disease must be refractory, meaning that the patient must have progressed on or after receiving, or was unable to tolerate, at least 1 anti-cancer treatment regimen containing 1 or more anti-cancer agents for their advanced disease, or the patient must have documented refusal of chemotherapy treatment for advanced disease.
    9. The patient must meet the requirement of a minimum period of 2 weeks between the last dose of radiotherapy or chemotherapy or 4 weeks between the last dose of an investigational anti-cancer product, and the first dose of the study drug.
    10. The patient must have fully recovered or reached a stable state of symptomatology from any previous treatment-related toxicity.
    11. The patient must have at least 1 target tumour that can be designated a principal target tumour.
    12. The patient must have adequate hepatic function [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN].
    13. The patient must have adequate renal function (serum creatinine < 1.5 × ULN).
    14. The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin >8 g/dL.
    15. The patient must have prothrombin time and partial thromboplastin time within normal limits.
    16. The patient must provide written informed consent.
    17. Women of childbearing potential (WOCBP) and male patients must be surgically incapable of bearing children or must agree to use a highly effective contraceptive method.
    Note: The ICH guidelines define a highly effective contraceptive method as one with a failure rate of less than 1% when used consistently and correctly, such as the double barrier method.
    E.4Principal exclusion criteria
    1. The patient’s locoregional disease is predominantly composed of tumours that do not meet the criteria of a target tumour.
    2. The patient has clinically significant distant metastases, including brain metastases.
    3. The patient is a candidate for either curative surgical resection or curative intent radiotherapy, chemo-radiotherapy or chemotherapy for their advanced disease.
    4. The patient has nasopharyngeal SCCHN.
    5. The patient has concurrent or documented history of any 1 of the following: known Acquired Immunodeficiency Syndrome, hepatitis C or hepatitis B.
    6. The patient has clinically significant renal or hepatic disease.
    7. The patient has Grade 3, or higher, bleeding from any tumour.
    8. The patient is pregnant or lactating.
    9. The patient requires regular use of therapy that significantly alters coagulation parameters to values that exceed the ULN and are unable to safely discontinue that therapy prior to randomization.
    10. The patient has any concomitant condition that, in the Investigator’s opinion, would make the patient inappropriate for study.
    11. The patient is currently enrolled in a clinical trial for another investigational therapy.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival time, measured as the time from randomization to death from any cause.
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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
    Best Supportive Care
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Yes
    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 stopped and the efficacy analyses will be performed once:
    • 240 deaths are achieved; or
    • all patients are withdrawn from the study, have died or have had at least 12 months study data recorded, whichever is sooner.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years3
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 292
    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 Decision2006-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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