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    Summary
    EudraCT Number:2004-002016-28
    Sponsor's Protocol Code Number:20040118
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-01
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-002016-28
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy (RT/CT)
    A.4.1Sponsor's protocol code number20040118
    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 Ltd
    B.1.3.4CountryUnited Kingdom
    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.2.5The 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 namePalifermin
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNPalifermin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.25
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human protein
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oral mucositis
    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 evaluate the efficacy of palifermin administered at the dose of 180 mcg/kg IV for either 4 or 7 (additional 8th dose for subjects receiving boost radiation) weekly doses in reducing the incidence of severe [World Health Organization Grade 3 or 4] oral mucositis (OM) in locally advanced HNC subjects receiving RT with concurrent CT as adjuvant treatment for their disease (post-operative setting).
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of palifermin at the dose of 180 mcg/kg IV in either 4 or 7 (additional 8th dose for subjects receiving boost radiation) weekly doses in this patient population.

    To evaluate the effect of palifermin on the clinical sequelae of severe OM and on RT induced xerostomia in this patient population.

    To evaluate long-term effects of palifermin on disease outcome and survival in this patient population.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Histologically documented squamous cell carcinoma.
    - Subjects with newly diagnosed (locally advanced) resected (R0, R1) HNC (American Joint Committee on Cancer [AJCC] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx and suitable to receive adjuvant concurrent RT/CT.
    - Radiation treatment field to receive planned dose of at least 50 Gy to areas of the oral cavity / oropharynx mucosa that can be visualized by non-instrumental oral inspection.
    - Subjects with larynx or hypopharynx tumors are eligible only if the radiation oncologist anticipates at least 2 of the 9 anatomical areas in the oral cavity [Mucositis Assessments] will receive a total dose of 50 Gy or more.
    - Signed informed consent.
    - Subject is 18 years of age or older.
    - ECOG performance status (PS) less than or equal to 2.
    - Planned interval < 6 calendar days between randomization and the first dose of RT.

    Baseline laboratory assessments:
    - Hemoglobin (Hgb) more than or equal to 10g/dL
    - White blood count (WBC) > 3.5 x 10E9/L or
    - Absolute neutrophil count (ANC) > 1.5 x 10E9/L.
    - Platelet count more than or equal to 100 x 10E9/L.
    - Serum bilirubin less than or equal to 1.5 x institutional upper limits of normal (ULN).
    - Serum creatinine less than or equal to 2.0 mg/dL; Subjects with a serum creatinine more than or equal to 1.4 mg/dL and less than or equal to 2.0 mg/dL need to demonstrate a 24-hr urinary creatinine clearance more than or equal to 50 mL/min.
    - Serum or urine pregnancy test: Negative
    E.4Principal exclusion criteria
    - Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors.
    - Metastatic disease (M1) / Stage IV C.
    - Presence or history of any other primary malignancy.
    - History of pancreatitis.
    - Prior radiotherapy to the site of disease.
    - Prior chemotherapy.
    - Other investigational procedures.
    - Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is for long-term follow-up/survival data.
    - Pregnant or breast-feeding women.
    - Refusal to use adequate contraceptive devices during treatment phase.
    - Known sensitivity to any of the products administered during dosing, including E coli-derived products.
    - Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
    - Previous treatment on this study or with other keratinocyte growth factors.
    - Compromised ability of the subject to give written informed consent and/or to comply with study procedures.
    - Refusal to give written informed consent to participate in this study and to sign the hospital information release form.
    - Unwilling or unable to complete the patient-reported outcome questionnaires.
    - Psychological, social, familial, or geographical reasons that would prevent regular follow-up.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    - Incidence (%) of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale).

    Secondary Efficacy Endpoints:
    - Duration of severe oral mucositis (WHO Grades 3 or 4).
    - Average daily patient-reported mouth and throat soreness score (as reported on the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer [OMWQ-HN])
    - Time to onset of severe oral mucositis (WHO Grades 3 or 4)·
    - Total dose of opioid analgesics used (mg of morphine equivalents)·
    - Incidence of unplanned breaks in RT more than or equal to 5 days (to include discontinuations of RT)
    - Incidence of unplanned breaks in CT more than or equal to 5 days (to include discontinuations of CT)
    - Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)

    Safety Endpoints: Short-term
    - Incidence of adverse events and laboratory abnormalities using the CTCAE v.3.0 toxicity scales.
    - Incidence of serum anti-palifermin antibody formation.
    - Disease progression at week 12.

    Safety Endpoints: Long-term
    - Time to disease progression.
    - Incidence of second primary tumors.
    - Incidence of other malignancies.
    - Progression-free survival (PFS).
    - Overall survival (OS).
    - Incidence of leukoplakia.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    NB. Pharmacogenetics additional only in subjects who sign a separate informed consent form.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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.8.5The 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
    Week 12 is the last observation point. All subjects will be followed up until death, or lost to follow up, for long-term safety evaluation.
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 2005-12-01. 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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 315
    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 Decision2005-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-11
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