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    EudraCT Number:2005-000213-35
    Sponsor's Protocol Code Number:Palifermin20020402
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-29
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-000213-35
    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 Radiotherapy With
    Concurrent Chemotherapy (RT/CT).
    Studio clinico di Fase 3, randomizzato, in doppio cieco, verso placebo, per valutare l’efficacia e la sicurezza di somministrazioni settimanali di Palifermin (Fattore di crescita per i cheratinociti ricombinante umano, rHuKGF) nella riduzione della mucosite orale in soggetti con neoplasia testa-collo (Head and Neck Cancer, HNC) in stadio avanzato che ricevono radioterapia e chemioterapia concomitante (RT/CT).
    A.3.2Name or abbreviated title of the trial where available
    Palifermin 2002402
    Palifermin 20020402
    A.4.1Sponsor's protocol code numberPalifermin20020402
    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 S.P.A.
    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.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 Yes
    D. name Kepivance
    D. of the Marketing Authorisation holderAMGEN Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical 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.3.10.3Concentration 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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. medicinal product typeNon Applicabile
    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
    Mucositis associated with radiation therapy and
    concurrent chemotherapy in subjects with HNC.
    Mucosite associata a radioterapia e chemioterapia concomitante in soggetti con HNC.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLT
    E.1.2Classification code 10024530
    E.1.2Term Lip and oral cavity neoplasms malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 µg/kg IV in 8 weekly doses relative to
    placebo in reducing the incidence of severe [World
    Health Organization Grade 3 or 4] oral mucositis (OM) in
    subjects with locally advanced HNC receiving RT/CT as
    definitive treatment for their disease.
    Valutare l’efficacia di palifermin somministrato alla dose di 180 mg/kg EV in 8 somministrazioni settimanali, rispetto al placebo, nella riduzione dell’incidenza della mucosite orale (MO) severa [grado 3 o 4 WHO] in soggetti con HNC, localmente avanzato, sottoposti a RT/CT come terapia definitiva per la loro patologia.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of palifermin at the
    dose of 180 µg/kg IV in 8 weekly doses compared to
    placebo during a 7-week course of RT/CT with cisplatin
    To evaluate the effect of palifermin on the clinical
    sequelae of severe OM (eg, average patient-reported
    mouth and throat soreness score), and on xerostomia
    To evaluate long-term effects of palifermin on disease
    outcome and survival after RT/CT.
    Valutare la sicurezza e la tollerabilita' di palifermin somministrato alla dose di 180 mg/kg EV in ragione di 8 somministrazioni settimanali versus placebo durante un trattamento di 7 settimane di RT/CT con cisplatino (CDDP).Valutare l’effetto di palifermin sulle sequele cliniche della MO severa (ad esempio la media dei punteggi riportati dal paziente riguardo il dolore alla bocca e alla gola) e sulla xerostomia .Valutare gli effetti a lungo termine di palifermin sull’esito della malattia e sulla sopravvivenza dopo RT/CT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    • Histologically documented squamous cell
    carcinoma involving either the oral cavity,
    oropharynx, nasopharynx, hypopharynx, or larynx
    • Absence of second primary tumor confirmed by
    triple endoscopy or by pharyngo/laryngoscopy
    combined with imaging evidence (PET or CT
    scan or MRI)
    • Newly diagnosed, locally advanced stage HNC
    (unresectable / unresected disease; American
    Joint Committee on Cancer [AJCC] Stage III,
    IVA, or IVB) amenable to RT/CT as the definitive
    treatment modality
    • Radiation treatment field to receive planned dose
    of at least 50Gy to areas of the oral cavity /
    oropharynx mucosa that can be visualized
    (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 listed in Section 7.4 of this protocol
    [Mucositis Assessments] will receive a total dose
    of 50 Gy).
    • Signed informed consent
    • Subject is 18 years of age or older
    • ECOG performance status (PS) &#8804; 2
    • Planned interval < 6 calendar days between
    randomization and the first dose of RT
    Baseline laboratory assessments:
    - Hemoglobin (Hgb) &#8805; 10g/dL
    - White blood count (WBC) > 3.5 x 109/L or
    - Absolute neutrophil count (ANC) > 1.5 x 109/L
    - Platelet count &#8805; 100 x 109/L
    - Serum bilirubin &#8804; 1.5 x institutional upper limits
    of normal (ULN)
    - Serum creatinine &#8804; 2.0 mg/dL; Subjects with a
    serum creatinine &#8805; 1.4 mg/dL and &#8804; 2.0 mg/dL
    need to demonstrate a 24-hr urinary creatinine
    clearance &#8805; 50 mL/min
    - Serum or urine pregnancy test: Negative
    Principali criteri di inclusione:
    · Carcinoma squamocellulare documentato istologicamente che coinvolga la cavita' orale o l’orofaringe, la nasofaringe, l’ipofaringe o la laringe
    · Assenza di un altro tumore primario confermata da tripla endoscopia o da faringo/laringoscopia combinata a diagnostica per immagini (PET o TAC o RM)
    · Nuova diagnosi di HNC, localmente avanzato (non resecabile/non resecato chirurgicamente; Stadio III, IVA, o IVB secondo l’American Joint Committee on Cancer – AJCC) che possano essere sottoposti a RT/CT come modalita' definitiva di trattamento.
    · Il campo di irradiazione deve comprendere aree di mucosa della cavita' orale/orofaringe che possano essere visualizzate e la dose dovra' essere di almeno 50 Gy.
    (I soggetti con tumori alla laringe o ipofaringe sono eleggibili solamente se il radiologo oncologo prevede che almeno 2 delle 9 aree anatomiche nella cavita' orale elencati nella sezione 7.4 di questo protocollo [Mucositis Assessments] riceveranno una dose complessiva pari a 50 Gy).
    · Firma del consenso informato
    · Soggetto di eta' pari o maggiore di 18 anni
    · ECOG (Eastern Cooperative Oncology Group) performance status (PS) £ 2
    · Intervallo programmato &lt; 6 giorni di calendario tra la randomizzazione e la prima somministrazione della RTParametri di laboratorio alla valutazione di “Baseline”:
    - Emoglobina (Hgb) ³ 10g/dL- Conta dei globuli bianchi (WBC) &gt; 3.5 x 109/L o Conta assoluta dei neutrofili (ANC) &gt; 1.5 x 109/L
    - Conta delle piastrine ³ 100 x 109/L
    - Bilirubina sierica £ 1.5 x limite superiore del “Normal Range” dell’ istituzione
    - Creatinina sierica £ 2.0 mg/dL; nei soggetti con creatinina sierica ³ 1.4 mg/dL e £ 2.0 mg/dL deve essere dimostrata una clearance della creatinina urinaria/24 ore ³ 50 mL/min
    - Test di gravidanza su siero o urine con esito negativo
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    • Tumors of the lips, paranasal sinuses, salivary
    glands, or of unknown primary
    • 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 pancreatitis
    • Plan to remove the tumor surgically before
    completing the protocol RT / CT course
    • 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 followup/
    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 coliderived
    • 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
    and Administration
    • Compromised ability of the subject to give written
    informed consent and/or to comply with study
    • 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 patientreported
    outcome questionnaires
    • Psychological, social, familial, or geographical
    reasons that would prevent regular follow-up.
    Principali criteri di esclusione:
    · Tumori delle labbra, dei seni paranasali, delle ghiandole salivari, o tumori primitivi latenti
    · Malattia metastatica (M1) / stadio IV C
    · Presenza o storia di altre neoplasie primarie (diversa da cancro cervicale trattato con intento curativo in situ o tumore a cellule basali della cute senza evidenza di malattia per &gt; 3 anni)
    · Storia di pancreatite
    · Rimozione chirurgica pianificata del carcinoma prima del completamento del trattamento di RT/CT previsto dal protocollo
    · Precedente radioterapia nel sito di malattia
    · Precedente chemioterapia
    · Altre procedure sperimentali
    · Intervallo di 30 gg o meno dal trattamento con un prodotto o un dispositivo sperimentale in un altro trial clinico
    . Non e' consentito il contemporaneo arruolamento in un’altra sperimentazione clinica a meno che l’unico scopo del trial sia l’acquisizione di dati di follow-up/sopravvivenza a lungo termine.
    · Donne incinte o che allattano
    · Rifiuto di ricorrere a idonei metodi di controllo delle nascite durante la fase di trattamento
    · Sensibilita' nota a uno qualsiasi dei prodotti somministrati durante il dosaggio, compresi prodotti derivati dall’E. coli
    · Nota sieropositivita' al virus dell’immunodeficienza umana (HIV), al virus dell’epatite B (HBV), o al virus dell’epatite C (HCV)
    · Precedente trattamento in questo studio o con altri fattori di crescita per i cheratinociti
    · Compromissione della capacita' del soggetto di dare il proprio consenso informato scritto e/o di conformarsi alle procedure di studio
    · Rifiuto di dare il proprio consenso informato scritto alla partecipazione a questo studio
    · Non intende o non e' in grado di compilare i questionari con le proprie valutazioni personali
    · Motivi psicologici, sociali, familiari o geografici che potrebbero impedire un regolare 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)
    Endpoint di efficacia primaria:
    · Incidenza (%) di mucosite orale severa (Grado 3 o 4 sulla scala WHO della mucosite orale)
    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 No
    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. 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 concerned6
    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 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
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months16
    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.1.1Number of subjects for this age range: 0
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 180
    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 Decision2006-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
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