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    Summary
    EudraCT Number:2007-001438-15
    Sponsor's Protocol Code Number:20062079
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-001438-15
    A.3Full title of the trial
    A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy in Subjects with Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
    A.4.1Sponsor's protocol code number20062079
    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 SponsorAmgen Inc.
    B.1.3.4CountryUnited States
    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 No
    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.3.2Product code AMG 954
    D.3.4Pharmaceutical form Intravenous 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.3.9.2Current sponsor codeAMG 954
    D.3.9.3Other descriptive namePanitumumab
    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 typerecombinant human monoclonal antibody IgG2
    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 Platosin 1mg/ml oplossing voor injectie
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma Belgium N.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameCisplatin
    D.3.4Pharmaceutical form Intravenous 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 INNCisplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) 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 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
    Advanced Squamous Cell Carcinoma of the Head and Neck
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    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 will be to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck
    (SCCHN).
    E.2.2Secondary objectives of the trial
    Secondary:
    To estimate the difference between 2 treatment regimens (CRT vs PRT) on other
    measures of clinical benefit, including LRC, overall response rate (ORR),
    progression-free survival (PFS), overall survival (OS); and safety.

    Tertiary:
    To estimate the difference in health-related quality of life (HRQoL) and performance
    status in subjects receiving PRT or CRT.

    Exploratory:
    To investigate potential biomarker development based on assessment of blood and
    tumor and the proposed mechanism of actions of study drugs. In addition, to investigate the effect of genetic variation in cancer genes and drug target genes on SCCHN and subject response to study drugs (separate informed consent required).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease-Related:
    • Histologically or cytologically confirmed SCC of oral cavity, oropharynx,
    hypopharynx, or larynx
    • Stage III or Stage IVa-b (M0) disease according to the American Joint Committee
    on Cancer staging manual 6th edition
    • ECOG performance status of 0 or 1 (refer to Appendix H)
    • Bidimensionally measurable disease ≥ 10 mm in at least 1 dimension

    Demographic:
    • Man or woman ≥ 18 years of age

    Laboratory:
    Hematological function, as follows (≤ 10 days prior to randomization):
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Hemoglobin ≥ 9 g/dL
    Renal function, as follows (≤10 days prior to randomization):
    • Creatinine clearance ≥ 50 mL/min as calculated from 24 hour urine collection (required for subjects with serum Cr > ULN) or calculated from the Cockcroft - Gault formula as follows:
    • Male creatinine clearance = (140 - age) x (weight in kg) / (serum Cr x 72)
    • Female creatinine clearance = (140 - age) x (weight in kg) x 0.85/(serum Cr x 72)
    Hepatic function, as follows (≤10 days prior to randomization):
    • Aspartate aminotransferase (AST) ≤ 2 x ULN
    • Alanine aminotransferase (ALT) ≤ 2 x ULN
    • Total bilirubin ≤ 2 x ULN
    Metabolic function, as follows (≤10 days prior to randomization):
    • Serum magnesium ≥ LLN
    • Negative pregnancy test ≤ 72 hours prior to randomization (females of
    child bearing potential)
    E.4Principal exclusion criteria
    Disease Related:
    • Primary tumor of the nasopharynx, sinuses, salivary gland, or skin
    • Subjects requiring prophylactic tracheostomy
    • Prior (or concomitant) malignancy (except non-melanomatous skin cancer or in situ
    cervical cancer), other than the study disease (SCCHN), unless treated with curative intent with no evidence of disease for ≥ 3 years

    Medications or Radiotherapy:
    • Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule
    tyrosine kinase inhibitors of EGFr (eg, gefitinib, erlotinib, lapatinib)
    • Prior surgery for SCCHN (except nodal sampling or biopsy for study disease)
    • Prior radiotherapy in the planned field
    • Prior systemic chemotherapy for the study cancer
    • Major surgery ≤ 28 days before randomization or minor surgery ≤ 14 days before
    randomization with the exception that feeding tube placement, dental extractions,
    central venous catheter placement, biopsies (endoscopic or otherwise), and nodal
    sampling are allowed at any time prior to randomization
    • Known allergy or hypersensitivity to any component of the study drugs

    General:
    • Clinically significant cardiovascular disease (including myocardial infarction,
    unstable angina, symptomatic congestive heart failure, serious uncontrolled
    cardiac arrhythmia) ≤ 1 year prior to randomization
    • Chronic obstructive pulmonary disease resulting in hospitalization due to
    pneumonia or respiratory decompensation ≤ 6 months prior to screening
    • History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or
    evidence of interstitial lung disease on screening chest CT scan
    • Active infection requiring systemic treatment or any uncontrolled infection ≤
    14 days prior to randomization
    • Any uncontrolled condition, which, in the opinion of the investigator, would interfere
    in the safe and timely delivery of study treatment
    • Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C
    virus, chronic active hepatitis B infection or any co-morbid disease that would increase the risk of toxicity
    • Pregnant or breast-feeding women
    • Men not willing to use adequate contraception precautions for the duration of the
    study and for 1 month following the last administration of study treatment
    • Women of childbearing potential not using adequate contraception precautions for
    the duration of the study and for 6 months following the last administration of study
    treatment
    • Subject unwilling or unable to comply with study requirements
    • Participation in other investigational device or drug studies within 30 days before
    randomization
    • Previously randomized into this study
    • Any kind of disorder that compromises the ability of the subject to give written
    informed consent and/or to comply with study procedures
    E.5 End points
    E.5.1Primary end point(s)
    Local-regional control (LRC) rates at 2 years: Defined as the Kaplan-Meier estimate of
    the proportion of subjects with LRC at 2 years. See below for the definition of duration of LRC.
    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 Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Cisplatin
    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.8.5.1Number of sites anticipated in the EEA26
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 150
    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 Decision2007-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-16
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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