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    Summary
    EudraCT Number:2004-002016-28
    Sponsor's Protocol Code Number:20040118
    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:2005-07-19
    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 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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effects of palifermin in reducing mouth ulceration in subjects with locally advanced head and neck cancer
    A.4.1Sponsor's protocol code number20040118
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00131638
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen
    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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23
    B.5.3.2Town/ cityP.O. Box 1557
    B.5.3.3Post codeCH-6301 Zug
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.com
    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 namePalifermin
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    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
    E.1.1.1Medical condition in easily understood language
    inflammation and ulceration that occurs in the mouth
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10028130
    E.1.2Term Mucositis oral
    E.1.2System Organ Class 100000004856
    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 120 mcg/kg IV in weekly doses (minimum of 7 weekly doses, until RT is complete) 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 120 mg/kg IV weekly doses (minimum of 7 weekly doses, until RT is complete) in this patient population. To evaluate the effect of palifermin on the clinical sequelae of severe OM (eg, average patient-reported mouth and throat soreness [MTS] score), 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 No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    • Histologically documented squamous cell carcinoma
    • Subjects with locally advanced, resected ( R0, R1) HNC ( American Joint Committee on Cancer [ AJCC] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx ,
    • 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 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) ≤ 2 Baseline laboratory assessments: - Hemoglobin ( Hgb) ≥ 10g/ dL -White blood count ( WBC) > 3.5 x 109/ L or - Absolute neutrophil count ( ANC) > 1.5 x 109/ L - Platelet count ≥ 100 x 109/ L - Serum bilirubin ≤ 1.5 x institutional upper limits of normal ( ULN) - Serum creatinine ≤ 2.0 mg/ dL; Subjects with a serum creatinine ≥ 1.4 mg/ dL and ≤ 2.0 mg/ dL need to demonstrate a 24- hr urinary creatinine clearance ≥ 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 (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for > 3 years).
    - History of chronic pancreatitis or an episode of acute pancreatitis within the last year
    - 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 ≥ 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT)
    - Incidence of unplanned delays in CT for cisplatin administration on Day 22 (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.

    Key Exploratory Endpoints:
    - Incidence of WHO Grade 2, 3, or 4 OM
    - Duration of WHO Grade 2, 3, or 4 OM
    - Time to WHO Grade 2, 3, or 4 OM
    - Maximum severity of OM (WHO scale and CTCAE v3.0 Mucositis scale)
    - Incidence of severe OM - Clinical Exam (Grades 3 or 4 on clinical exam of oral cavity CTCAE v3.0 Mucositis scale)
    - Duration of severe OM
    - Clinical Exam (Grades 3 or 4 on clinical exam of oral cavity CTCAE v3.0 Mucositis scale)
    - Time to severe OM - Clinical Exam (Grades 3 or 4 on clinical exam of oral cavity CTCAE v3.0 Mucositis scale)
    - Incidence of opioid analgesic use
    - Duration (days) of opioid analgesic use
    - Incidence of CTCAE Grade ≥2 salivary gland changes (CTCAE v3.0 Salivary Gland Changes scale Grade 2 or higher)
    - Time to CTCAE Grade ≥2 salivary gland changes (CTCAE v3.0 Salivary Gland Changes scale Grade 2 or higher)
    - Incidence of PEG tube/nasogastric (NG) tube/total parenteral nutrition (TPN)/ intravenous (IV) hydration utilization
    - Duration of PEG tube/NG tube/TPN/ IV hydration utilization - Changes in body weight (kg)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Oral mucosa evaluations will be performed:
    • At baseline
    • Twice weekly throughout RT/CT until resolution of OM to WHO Grade ≤ 2
    • Once weekly thereafter until resolution of OM to WHO Grade ≤ 1
    • If severe OM is not resolved by the week 12 visit, twice weekly assessments should be continued until week 15. If after the week 15 visit, OM is greater than or equal to WHO Grade 2, the OM evaluations should continue weekly until resolved to WHO Grade ≤ 1.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • Duration of severe oral mucositis (WHO Grades 3 or 4)
    • Average patient-reported mouth and throat soreness score (as reported on Question 3 of the Oral Mucositis Weekly Questionnaire for patients with 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 ≥5 days (to include discontinuations of RT)
    • Incidence of unplanned breaks in CT ≥5 days (to include discontinuations of CT)
    • Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Oral mucosa evaluations will be performed:
    • At baseline
    • Twice weekly throughout RT/CT until resolution of OM to WHO Grade ≤ 2
    • Once weekly thereafter until resolution of OM to WHO Grade ≤ 1
    • If severe OM is not resolved by the week 12 visit, twice weekly assessments should be continued until week 15. If after the week 15 visit, OM is greater than or equal to WHO Grade 2, the OM evaluations should continue weekly until resolved to WHO Grade ≤ 1.
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    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.8.2.4Number of treatment arms in the trial2
    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 EEA38
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Canada
    France
    Germany
    Italy
    Spain
    United Kingdom
    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
    Week 12 is the last observation point. All subjects will be followed up until death, loss to follow-up, or for up to 10 years from the last subject randomized.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.2.1Number of subjects for this age range: 151
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 155
    F.4.2.2In the whole clinical trial 186
    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)
    Not Applicable
    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 Decision2005-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-11
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