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    Summary
    EudraCT Number:2007-005722-79
    Sponsor's Protocol Code Number:20050236
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-22
    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 number2007-005722-79
    A.3Full title of the trial
    A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy with or without Panitumumab as First-line Treatment of Subjects with Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects who Fail the Combination Chemotherapy Only Arm.
    A.4.1Sponsor's protocol code number20050236
    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 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 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 nameABX-EGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 or 20
    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.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
    Cancer 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
    To estimate the effect of panitumumab on progression free survival (PFS) when added to combination chemotherapy in first-line treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).
    E.2.2Secondary objectives of the trial
    1) To estimate the effect of panitumumab on the following endpoints when added to
    combination chemotherapy in first-line treatment of metastatic or recurrent SCCHN:

    • Overall response rate (ORR)
    • Rate of disease control
    • Duration of response
    • Time to response
    • Overall survival (OS)

    2) To describe the safety of panitumumab when added to combination chemotherapy

    3) To describe PFS, ORR, rate of disease control, duration of response, time to
    response, and OS for second-line panitumumab monotherapy (ie, after failure of
    combination chemotherapy)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria

    The following inclusion criteria must be met at the time of subject randomization.
    Disease Related

    • Histologically or cytologically confirmed SCCHN or its variants (eg, basaloid
    squamous cell carcinoma and adenosquamous cell carcinoma).

    • Primary tumor of the oropharynx, oral cavity, hypopharynx, or larynx, or
    SCCHN of unknown primary.

    • Diagnosis of metastatic disease and/or recurrent disease determined to be
    incurable by surgery or radiotherapy.

    • No prior systemic treatment for metastatic and/or recurrent SCCHN

    • Subjects who have received radiation as primary therapy are eligible if radiation
    therapy treatment was completed > 4 weeks prior to randomization

    • Subjects who have previously received chemotherapy as part of the initial
    multimodality treatment for locally advanced disease are eligible if the
    chemotherapy was completed > 24 weeks prior to randomization

    • At least 1 unidimensionally measurable lesion of ≥ 20 mm using conventional
    techniques or ≥10 mm with spiral CT scan. Target lesions must not be chosen
    from a previously irradiated field unless there had been documented tumor
    progression in that lesion prior to randomization
    • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
    at screening

    Demographic

    • Men or women age ≥ 18 years and < 70 years

    Laboratory

    • Adequate hematologic data as follows (≤ 7 days before randomization):
    - ANC ≥ 1.5 x 109/L
    - Platelet count ≥ 100 x 109/L
    - Hemoglobin ≥ 9.0 g/dL

    • Adequate renal function (≤ 7 days before randomization):
    - Adequate renal function with creatinine clearance ≥ 50 mL/min calculated
    by the Cockcroft-Gault method 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)

    • Electrolyte function, as follows (≤ 7 days before randomization). If < lower limit of
    normal (LLN), subject may receive appropriate treatment and may be
    rescreened.
    - Magnesium ≥ LLN
    - Calcium ≥ LLN (If serum albumin is low, corrected calcium or ionized
    calcium should be ≥ LLN)
    - Potassium ≥ LLN

    • Adequate hepatic function as determined by (≤ 7 days before randomization):
    - Aspartate aminotransferase (AST) ≤ 1.5 x upper limit of normal (ULN)
    - Alanine aminotransferase (ALT) ≤ 1.5 x ULN
    - Alkaline phosphatase (ALK-P) ≤ 2.5 x ULN
    - Total bilirubin ≤ ULN, unless attributed to Gilbert’s syndrome

    • Negative urine or serum pregnancy test ≤ 72 hours prior to randomization
    (females of childbearing potential only)

    Ethical

    • Before any non-standard of care study-specific procedure, subjects or their
    legally acceptable representative must be able to comprehend and have signed
    and dated the applicable independent ethics committee (IEC) or institutional
    review board (IRB) approved written Informed Consent Form (ICF).
    E.4Principal exclusion criteria
    Exclusion Criteria

    Subjects who meet any of the following criteria at the time of randomization must be
    excluded from participation in this study.

    Disease Related

    • Documented or symptomatic central nervous system (CNS) metastases

    • Nasopharyngeal carcinoma

    • History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or
    evidence of interstitial lung disease on baseline chest computerized tomography
    (CT) scan

    • History of another primary cancer, except:
    - Curatively treated in situ cervical cancer, or
    - Curatively resected non-melanoma skin cancer or
    - Other primary solid tumor curatively treated with no known active disease
    present and no treatment administered for ≥ 3 years prior to
    randomization

    • Clinically significant cardiovascular disease (including myocardial infarction,
    unstable angina, symptomatic congestive heart failure, serious uncontrolled
    cardiac arrhythmia) ≤ 1 year of randomization

    • Subjects whose only site of metastatic disease is a single spiculated lung nodule
    are assumed to have a second lung primary, and are excluded unless there is
    unequivocal pathological confirmation of metastasis of the SCCHN primary

    • Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic
    event ≤ 8 weeks prior to randomization

    • Symptomatic peripheral neuropathy of Grade ≥ 2 based on the CTCAE v3.0
    (Symptomatic weakness and/ or sensory alteration or paresthesia (tingling) that
    is interfering with function but not interfering with Activities of Daily Living
    [ADL])

    • Subjects not recovered from all previous acute radiotherapy-related toxicities to ≤
    grade 1

    • History of severe skin disorder that in the opinion of the investigator may interfere
    with study conduct

    • Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C
    virus, acute or chronic hepatitis B infection

    • Any co-morbid disease that would increase risk of toxicity

    • History of any medical, or psychiatric condition, or laboratory abnormality that in
    the opinion of the investigator may increase the risks associated with the study
    participation, or may interfere with the interpretation of the results

    • Active infection requiring systemic treatment or any uncontrolled infection ≤ 14
    days prior to randomization

    • Hearing loss of Grade ≥ 3 based on the CTCAE v3.0 Auditory/Ear (Hearing loss
    requiring hearing aid or intervention (ie, interfering with ADL [without monitoring
    program])

    Medications and Treatments

    • Known allergy or hypersensitivity to panitumumab, or other study medications.

    • Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small
    molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) unless received as
    part of prior multimodality treatment (eg, as a radiation sensitizer) and
    completed > 24 weeks prior to randomization.

    • Subject is currently enrolled in or ≤ 30 days since ending other investigational
    device, investigational procedure, or drug study(s), or subject is receiving other
    investigational agent(s)

    • Subjects requiring use of immunosuppressive agents (eg, methotrexate and
    cyclosporine), however, corticosteroids are allowed

    General

    • Man or woman of child-bearing potential (women who are post-menopausal < 52
    weeks, not surgically sterilized, or not abstinent) who do not consent to use
    adequate contraceptive precautions (per institutional standard of care) during the
    course of the study, and for 24 weeks after the last dose of therapy
    administration for women and 4 weeks for men.

    • Female subject who is pregnant or breast-feeding

    • Subject unwilling or unable to comply with study requirements

    • Major surgery requiring general anesthesia/ spinal anesthesia and a significant
    incision (ie, larger than what is required for placement of central venous access,
    percutaneous feeding tube, or biopsy) ≤ 28 days or minor surgery (excluding
    central venous placement, percutaneous feeding tube, and biopsy) ≤ 14 days
    prior to randomization. Subjects must have recovered from surgery-related
    toxicities.

    • Any kind of disorder that compromises the ability of the subject to give written
    informed consent and/or to comply with study

    • Previously randomized into this study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is PFS during the first-line treatment phase. Duration of PFS is
    defined as the time from the date of randomization to the first date of observed disease progression, as defined by modified RECIST, or death due to any cause, (whichever comes first). Subjects who are alive and have not progressed will be censored at the date of last evaluable disease assessment during the first-line treatment phase.
    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 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) 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.8.3 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 EEA35
    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 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
    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 months8
    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 months8
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 110
    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 Decision2008-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-06
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