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    Summary
    EudraCT Number:2004-005007-14
    Sponsor's Protocol Code Number:20040122
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-03-18
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2004-005007-14
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy
    and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) for Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer Receiving 5-FU and Leucovorin as Adjuvant Therapy
    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 advanced colon cancer
    A.4.1Sponsor's protocol code number20040122
    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 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 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 pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone numberN/A
    B.5.5Fax numberN/A
    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 (Kepivance)
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpalifermin
    D.3.9.2Current sponsor codepalifermin
    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 bolus use (Noncurrent)
    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
    Mouth Ulcers
    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 16.1
    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 effect of palifermin on the incidence of Grade ≥ 2 OM induced by adjuvant chemotherapy in subjects with stage 2B and 3 locally advanced colon cancer in cycle 1, when administered as a single dose of 120 μg/kg three days prior to each 4-week cycle of 5-FU and leucovorin
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of palifermin administered as a single dose of
    120 μg/kg IV before each cycle of 5-FU and leucovorin
    To evaluate the effect of palifermin on patient-reported mouth and throat soreness
    To evaluate the incidence of Grade ≥ 2 OM in cycle 2
    To evaluate the duration of Grade ≥ 2 OM
    To evaluate 5-FU dose reductions/delays
    To evaluate the long-term effects of palifermin on disease outcome and survival

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease Related
    • Histologically confirmed diagnosis of colon adenocarcinoma
    • Newly diagnosed stage 2B or 3 (AJCC staging criteria; see Appendix F) resected colon carcinoma and a candidate for 5-FU/LV treatment
    Demographic
    • 18 years of age or older
    • ECOG performance status ≤ 1
    Baseline Laboratory
    • Hemoglobin (Hgb) ≥ 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor use in the 2 weeks before study randomization
    • Platelet count ≥ 100 x 109/L
    • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
    • Serum creatinine ≤ 2.0 mg/dL
    • Serum AST ≤ 5 x ULN
    • Females of childbearing potential: negative serum or urine pregnancy test
    Ethical
    • Subject must give written informed consent before participating in any study-specific procedure
    General
    • Subjects with reproductive capability must agree to practice adequate contraception methods
    • Absence of other serious concurrent medical illness
    • Willingness to participate in subsequent long-term follow-up study
    E.4Principal exclusion criteria
    Disease Related
    • Previous therapy (eg, chemotherapy, radiotherapy or biological therapy) for colon cancer, other than surgical tumor resection
    • Presence or history of any other primary malignancy
    • Presence of active or chronic oral mucositis or xerostomia
    • Presence of active diarrhea > grade 1 according to CTCAE v. 3 grading criteria within three days prior to randomization
    • History of pancreatitis
    Medication/Prior Treatment
    • Four weeks or less since completion of treatment using an investigational product or device in another clinical study or presence of any unresolved toxicity from previous treatment
    • Known sensitivity to any of the products administered during dosing, including E. coli-derived products
    • Previous treatment on this study or with other keratinocyte growth factors
    Laboratory
    • Known to be sero-positive for human immunodeficiency virus (HIV) or Hepatitis C Virus (HCV)
    General
    • Subjects who would be unwilling/unable to complete daily patient-reported outcome questionnaires
    • Subjects of childbearing potential not using adequate contraceptive precautions
    • Pregnant or breast-feeding women
    • Psychological, social, familial, or geographical reasons that would prevent regular follow-up
    • Compromised ability of the subject to give written informed consent and/or to comply with study procedures
    • Refusal to sign an informed consent form to participate in this study or, if applicable, refusal to sign the hospital information release form
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of grade ≥ 2 (WHO scale) OM in cycle 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 week (as per assessment at cycle 1)
    E.5.2Secondary end point(s)
    Secondary:
    • Incidence of grade ≥ 2 (WHO scale) OM in cycle 2
    • Average MTS score (OMDQ Question 2) in cycle 1
    • Average MTS score (OMDQ Question 2) in cycle 2
    • Incidence of 5-FU dose reductions and dose delays in cycle 2
    • Duration of Grade ≥ 2 (WHO scale) OM in cycle 1
    • Duration of Grade ≥ 2 (WHO scale) OM in cycle 2
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 1 and week 2

    After completion of, or withdrawal from, the treatment phase, subjects
    will continue onto the long-term follow-up phase and will be monitored
    for disease progression, second primary tumors, other malignancies
    and overall survival until considered lost to follow-up, death, or for up
    to 5 years from the last subject randomized.
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Belgium
    Czech Republic
    Hungary
    Poland
    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
    After completion of, or withdrawal from, the treatment phase, subjects will continue onto the long-term follow-up phase and will be monitored for disease progression, second primary tumors, other malignancies and overall survival until considered lost to follow-up, death, or for up to 5 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 years10
    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 years10
    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.1.2.1Number of subjects for this age range: 51
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 49
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Plans for treatment of care after the subject has ended participation are not different from the expected normal treatment for this condition.
    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 Decision2005-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-31
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