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    Summary
    EudraCT Number:2008-006180-36
    Sponsor's Protocol Code Number:22071-24071
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-08
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2008-006180-36
    A.3Full title of the trial
    Randomized Phase III trial on postoperative chemoradiation in combination with anti EGFR-antibody versus postoperative chemoradiation in head and neck squamous cell carcinomas (HNSCC) with high risk of locoregional recurrence
    A.4.1Sponsor's protocol code number22071-24071
    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 SponsorEORTC - European Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 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 Yes
    D.2.1.1.1Trade name Vectibix
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 namePanitumumab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 typefully human monoclonal antibody
    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
    head and neck squamous cell carcinomas (HNSCC) with high risk of locoregional recurrence
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The proposed study tests the hypothesis that the addition of concurrently administered panitumumab to standard adjuvant chemoradiation significantly prolongs disease free survival in macroscopically completely resected advanced head and neck cancer at high risk of recurrence.
    E.2.2Secondary objectives of the trial
    Toxicity and Quality of life
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Selected institutions can register patients at the time of the first biopsy and participate to an administration of a 2.5 mg/kg dose of panitumumab 7-11 days before surgery (biological pre-study).

    Fresh frozen tissues from tumor biopsies will be collected before the administration of the panitumumab pre-surgery dose and from the resected tumors after the dose.

    The hypothesis is that the pre-surgery dose of panitumumab will alter the RNA expression of several genes and that these changes will provide additional prognostic information that can be used in future patient management. These differences in RNA expression could be measured by RNA microarray and the results
    analyzed to create a gene expression classifier that will be checked for outcome prediction in two ways:
    (1) association with DFS, e.g. in the group predicted as positive by the gene expression classifier
    (2) down regulation of the glucose metabolism as measured by FDG-PET.

    For this purpose, must be collected for each participating patient:
    ¨ One serum sample before and after the panitumumab pre-surgery dose (one vial of 10 ml each),
    ¨ Paraffin-embedded and frozen samples of the tumor from the biopsy and from the surgical specimen, i.e. before and after administration of the panitumumab pre-surgery dose.

    The rate of postoperative complications will be monitored and will be used for stopping the biological prestudy early in case it appears to interfere with the wound healing process.
    Those biological samples will be sent and stored in the central repository BioRep S.r.l., Via Fantoli 16/15, 20138 Milan, Italy.
    E.3Principal inclusion criteria
    ¨ Surgically resected primary squamous cell carcinomas (HNSCC) of the hypopharynx, oropharynx, larynx and oral cavity with pathological stage pT1-2 pN+ or pT3-4 any pN (UICC 6th edition, 2002)(patients with nasopharynx, nasal cavity and paranasal sinuses carcinomas, or recurrent HNSCC, or those treated with laser surgery are not eligible);
    ¨ High risk of locoregional recurrence defined as fulfilling at least one of the following criteria:
    - Close surgical margins (i.e. margins 1 mm to < 5 mm), or
    - R1-resection (<1 mm) (R2 resection is considered as not eligible) and/or
    - Extracapsular nodal extension;
    ¨ p16 immunohistochemistry assay performed on tissue sections taken during the surgical procedure;
    ¨ Presurgical contrast enhanced CT-scan or MRI scan of the head and neck;
    ¨ Start of adjuvant treatment within 8 weeks of surgery (10 weeks will be accepted in case of postoperative complications);
    ¨ Age between 18 and 75 years;
    ¨ Performance status WHO/ECOG: 0 – 1;
    ¨ All patients (male and female) must use effective contraception methods according to CPMP/ICH/286/95 if of reproductive potential (e.g. implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner), for the whole duration of the study and until six months after they received the last treatment dose;
    ¨ Females must not be pregnant at entry or breastfeeding;
    ¨ Adequate renal, liver and hematological functions:
    ¨ Adequate bone marrow function: neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 10.0 g/dL;
    ¨ Adequate liver function: bilirubin < 1.5 x ULN, AST< 3 x ULN, alkaline phosphatases < 3 x ULN;
    ¨ Adequate renal function: calculated creatinine clearance ≥ 60 ml/min (MDRD formula, see paragraph 5.5.2.2.3);
    ¨ Electrolyte balance: calcium ≤ 11.5 mg/dl or 2.9 mmol/l, magnesium ≥ 1.2 mg/dl or 0.5 mmol/l;
    ¨ Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    ¨ Distant metastases (CT-scan of chest and upper abdomen are recommended. Chest X-ray and abdominal ultrasonography can be used. Bone scintigraphy is recommended but not mandatory);
    ¨ Known allergic/hypersensitivity reaction to any of the components of the treatment;
    ¨ Other serious illnesses or medical conditions present at the time of entry on study, including:
    - History or evidence of interstitial pneumonitis, pulmonary fibrosis;
    - Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4;
    - Clinically significantly abnormal electrocardiogram (ECG) or left ventricular ejection fraction (LVEF) below the institutional lower limit of normal (LLN);
    - Known HIV infection or other conditions of persistent immunodeficiency infection;
    - Significant neurological or psychiatric disorders;
    - Active uncontrolled infection;
    - Active disseminated intravascular coagulation;
    - Symptomatic peripheral neuropathy (CTCAE 4.0 "peripheral sensory neuropathy and paresthesia") ≥ grade 2 or ototoxicity (CTCAE 4.0 "hearing impaired") ≥ grade 2, except if due to trauma or mechanical impairment due to tumor mass;
    - Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
    ¨ Participation in another interventional clinical trial in the preceding 30 days;
    ¨ Previous chemotherapy or radiotherapy for carcinoma of the head and neck;
    ¨ Previous radiotherapy in the head and neck region;
    ¨ Prior exposure to EGFR pathway targeting therapy;
    ¨ History within the past 5 years of malignancies other than basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix. Patients with any history of malignancies who are disease-free for more than 5 years are eligible.
    ¨ Known drug abuse;
    ¨ Any psychological, familial, sociological (e.g. severe alcohol addiction expected to hamper protocol compliance) or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival (DFS, defined as the time from the day of randomization to the day of first report of locoregional recurrence, distant metastases, second primary cancer or death from any cause).
    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 Yes
    E.6.13.1Other scope of the trial description
    Translational Research on biological material; Quality of life
    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
    standard adjuvant chemoradiation
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    c.f. Protocol:
    End of study occurs when all of the following criteria have been satisfied:
    1. Thirty days after all patients have stopped protocol treatment.
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol.
    3. The database has been fully cleaned and frozen for this analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 780
    F.4.2.2In the whole clinical trial 800
    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)
    c.f. Protocol
    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 Decision2010-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-18
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