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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-003116-33
    Sponsor's Protocol Code Number:20030185
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-09-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-003116-33
    A.3Full title of the trial
    A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin
    (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
    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 the difficulty of swallowing in patients receiving chemoradiotehrapy and chemotherapy in lung cancer patients
    A.4.1Sponsor's protocol code number20030185
    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 SponsorSwedish Orphan Biovitrum (Sobi) AB (publ)
    B.1.3.4CountrySweden
    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 supportSwedish Orphan Biovitrum AB (publ)
    B.4.2CountrySweden
    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.3.2Product code V03A F08
    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
    Dysphasia
    E.1.1.1Medical condition in easily understood language
    Difficulty in Swallowing
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10013950
    E.1.2Term Dysphagia
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 single weekly doses of 180 μg/kg in reducing the incidence of dysphagia (grade ≥ 2) induced by concurrent chemoradiotherapy (CT/RT) followed by consolidation chemotherapy in patients with unresectable stage III non-small cell lung cancer (NSCLC).
    E.2.2Secondary objectives of the trial
    - To evaluate the safety of palifermin administered at single weekly doses of 180 μg/kg (a total of 7 doses)
    - To assess the effect of palifermin on treatment-related clinical sequelae


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease Related:
    - Patients with a histologically or cytologically proven diagnosis of NSCLC
    - Unresectable (locally advanced) stage IIIa or IIIb disease
    - Initial RT field of treatment to encompass ≥ 30% of the esophagus
    - Life expectancy ≥ 6 months
    - Estimated weight loss ≤ 10% in the 3 months before study randomization
    - Measurable disease
    Demographic:
    - 18 years of age or older
    - ECOG performance status of 0-2 (see Appendix F) Screening 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 10e9/L without growth factor use in the 2 weeks before study randomization
    - Platelet count ≥ 100 x 10e9/L
    - Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
    - Serum creatinine ≤ 2.0 mg/dL (Note: Subjects with a serum creatinine ≥ 1.4 and ≤ 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min.)
    - Females of childbearing potential: negative serum or urine pregnancy test
    Ethical:
    - Subject must give written informed consent before participating in any study-specific procedure, randomization,
    or receiving investigational product.
    General:
    - Subjects with reproductive capability must agree to practice adequate contraception methods.
    E.4Principal exclusion criteria
    Disease Related:
    - Metastatic disease (M1)/stage 4 NSCLC
    - Pleural or pericardial effusion greater than 100 ml in volume as documented by appropriate imaging ( PET, CT scan or ultrasound). If an effusion greater than 100 ml is documented by cytology to be free from malignancy and the investigator feels the subject is capable of receiving RT/ CT for their primary disease/ NSCLC, the investigator should discuss the patient with the study physician at Amgen. Effusions smaller than 100 ml would be acceptable, unless the investigator suspects that the effusion is malignant, in which case the effusion should be evaluated by cytology. Sponsor approval must be obtained before subject is randomized.
    - Plan to remove the tumor surgically before completing the protocol CT/RT course
    - Shielding of any part of the esophagus during RT (including posterior spinal cord shielding)
    - Prior chemotherapy, radiotherapy, or surgery for NSCLC
    - Prior invasive malignancy during the past 3 years other than non-melanomatous skin cancer. Note: Subjects with prior surgically-cured malignancies [eg, stage I breast cancer or prostate cancer, in-situ carcinoma of the cervix, etc] are not excluded; however, sponsor approval must be obtained before subject is randomized.
    - Presence or history of dysphagia or conditions predisposing to dysphagia (eg, uncontrolled gastroesophageal reflux disease [GERD], dyspepsia, etc)
    - History of pancreatitis
    Medication/Prior Treatment:
    - Four weeks or less since completion of treatment using an investigational product/device in another clinical study or presence of any unresolved toxicity from previous treatment
    - Previous treatment on this study or with a fibroblast growth factor
    Laboratory:
    - Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
    General:
    - Pregnant or breastfeeding women
    - Known sensitivity to E coli derived products
    - 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, and sign the hospital information release form, if applicable
    - Unwilling or unable to complete the PRO questionnaires
    - Psychological, social, familial, or geographical reasons that would prevent regular follow-up
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of dysphagia (grade ≥ 2) measured using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    All subjects will undergo dysphagia assessments using the CTCAE v3.0 dysphagia scale twice weekly during weeks 1 through 7, and twice weekly thereafter (weeks 8 through 12) until dysphagia resolves to grade ≤ 1. Subjects still experiencing grade ≥ 2 dysphagia at the end of week 12 will continue to have once weekly dysphagia assessments until dysphagia resolves to grade ≤ 1 (but not beyond week 16).
    E.5.2Secondary end point(s)
    Secondary:
    Duration (days) of grade ≥ 2 dysphagia
    - Maximum severity of dysphagia
    - Incidence of severe (grade ≥ 3) dysphagia
    - Change in performance status and body weight (kg)
    - Incidence of unplanned breaks in RT (to include discontinuations of RT)
    - Patient-reported outcomes (PRO):
    - Functional Assessment of Cancer Therapy - Esophageal Cancer (FACT-E) average Swallowing Index score during the acute dysphagia evaluation phase (baseline through week 12)
    - Related Clinical Sequelae
    - Incidence and cumulative dose of opioid analgesics use (morphine equivalents)
    - Incidence and duration (days) of hospitalization
    - Incidence of percutaneous endoscopic gastrostomy (PEG)/nasogastric (NG) tube, total parenteral nutrition (TPN), and IV hydration use
    - Incidence of infections
    Short term safety:
    - Incidence of adverse events (AEs) and laboratory abnormalities using the CTCAE v3.0 toxicity criteria
    - Incidence of serum anti-palifermin antibody formation
    - Tumor response at week
    Long term safety:
    - Incidence of chronic dysphagia defined as unresolved dysphagia (grade ≥ 2) at month 6
    - Incidence of pneumonitis measured using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema
    - Incidence of second primary tumors
    - Incidence of other malignancies
    - Progression-free survival (PFS)
    - Overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All subjects will undergo dysphagia assessments using the CTCAE v3.0 dysphagia scale twice weekly during weeks 1 through 7, and twice weekly thereafter (weeks 8 through 12) until dysphagia resolves to grade ≤ 1. Subjects still experiencing grade ≥ 2 dysphagia at the end of week 12 will continue to have once weekly dysphagia assessments until dysphagia resolves to grade ≤ 1 (but not beyond week 16).

    Long-term follow-up will end after 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) 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 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    France
    Germany
    Poland
    Spain
    United States
    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
    All subjects will be followed up until death or lost to follow up, or for up to five 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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 40
    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 Decision2005-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-20
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