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    Summary
    EudraCT Number:2006-004566-13
    Sponsor's Protocol Code Number:EMR62206-017
    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:2007-07-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-004566-13
    A.3Full title of the trial
    An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.
    Uno studio aperto, randomizzato, di Fare II in soggetti affetti da carcinoma polmonare a piccole cellule malattia estesa (ED-SCLC), dopo una risposta iniziale (risposta completa o risposta parziale) alla terapia a base di platino per valutare l'effetto di EMD 273066 dopo ciclofosfamide a basse dosi sulla progressione della malattia e sulla sopravvivenza rispetto alla migliore terapia di supporto da sola
    A.4.1Sponsor's protocol code numberEMR62206-017
    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 SponsorMERCK KGaA
    B.1.3.4CountryGermany
    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 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 nameNA
    D.3.2Product code EMD 273066
    D.3.4Pharmaceutical form Solution for infusion
    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 INNInterleukins
    D.3.9.2Current sponsor codeEMD 273066
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number1.5
    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 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.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    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.2.1.1.1Trade name ENDOXAN BAXTER
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNCyclophosphamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.3.11.13.1Other medicinal product typeNon Applicabile
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    extensive disease, small cell lung
    cancer (ED-SCLC)
    carcinoma polmonare a piccole cellule - malattia estesa (ED-SCLC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10041071
    E.1.2Term Small cell lung cancer stage unspecified
    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
    The primary objective of this study is to determine if
    exposure to EMD 273066 will increase the proportion
    of subjects with
    o Progression-free survival (PFS) at 6 months
    after randomisation
    L'obiettivo primario di questo studio e' determinare se l'esposizione a EMD 273066 aumentera' la percentuale di soggetti con
    o Sopravvivenza libera da progressione di malattia (PFS) 6 mesi dopo la randomizzazione
    E.2.2Secondary objectives of the trial
    o To determine overall survival (OS) at 12 and 18
    months (from beginning of first-line, platinumbased
    chemotherapy)
    o To determine median time to progression (TTP)
    after randomisation
    o To characterize the safety and tolerability of
    treatment with low-dose cyclosphosphamide(CTX) followed by EMD 273066
    o To collect additional immunogenicity data from
    subjects exposed to EMD 273066
    o To determine the objective response rate in
    subjects receiving second-line chemotherapy
    after disease progression
    o Determinare la sopravvivenza globale (OS) a 12 e 18 mesi (dall'inizio della chemioterapia di prima linea a base di platino)
    o Determinare il tempo medio alla progressione (TTP) dopo la randomizzazione
    o Caratterizzare la sicurezza e la tollerabilita' della terapia con ciclofosfamide (CTX) a basse dosi seguita da EMD 273066
    o Raccogliere dati addizionali di immunogenicita' in soggetti esposti a EMD 273066
    o Determinare il tasso di risposta obiettivo in soggetti che ricevono la chemioterapia di seconda linea dopo la progressione della malattia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed written informed consent
    • &#8805;18 years of age
    • Histologically documented SCLC
    • Radiologically demonstrated extensive-stage
    disease by thoracic and abdominal CT or MRI
    scan prior to induction chemotherapy
    • Received 4 cycles of platinum-based, first-line
    chemotherapy (12-14 weeks) without thoracic
    irradiation
    • Experienced a response to platinum-based,
    first-line chemotherapy (CR or PR according to
    RECIST shown after second and fourth course
    of induction chemotherapy compared to
    findings prior to induction therapy)
    • Confirmatory CT or MRI scan
    • Negative CT scan of the head
    • Be enrolled and begin treatment 3-5 weeks after
    last infusion of platinum-based, first-line
    chemotherapy
    • Life expectancy &#8805;4 months
    • ECOG performance status &#8804;2 at study entry
    • No clinical history of significantly impaired
    renal function or chronic kidney disease. Must
    have an estimated glomerular filtration rate &#8805;50
    mL/min determined by the Cockgraft-Gault
    formula No significant haematologic abnormalities,
    including white blood cell count &#8805;2.5 × 103/&#956;l
    (or total granulocytes &#8805;1 × 103/&#956;l), absolute
    lymphocyte count &#8805;0.5 × 103/&#956;l, platelet count
    &#8805;100 000/&#956;l, and haemoglobin level >5.5
    mmol/L
    • No significant hepatic abnormalities, including
    alanine aminotransaminase and aspartate
    aminotransaminase &#8804;2.5 × the upper limit of
    normal (ULN), or &#8804;5 × ULN in case of liver
    metastasis, and total bilirubin <1.5 × ULN
    • No significant electrolyte abnormalities,
    including serum sodium, potassium, and
    phosphorus within normal limits
    • Serologic testing within 4 weeks prior to
    starting study treatment with negative results
    for hepatitis C virus (HCV), human
    immunodeficiency virus (HIV), and hepatitis B
    virus (HBV) demonstrated by negative hepatitis
    B core antibody (HBcAb) and hepatitis surface
    antigen (HbsAg)
    • Negative urine &#946;-HCG pregnancy test and
    willingness to use effective contraception for
    both male and female subjects for the study
    duration and 1 month thereafter if of
    procreative potential; non-lactating females
    • Consenso informato scritto firmato
    • &#8805;18 anni d'eta'
    • Carcinoma polmonare a piccolo cellule (SCLC) istologicamente documentato
    • Patologia in fase estesa radiologicamente dimostrata con la tomografia computerizzata o la risonanza magnetica del torace e dell'addome prima della chemioterapia di induzione
    • Ricevuto 4 cicli di chemioterapia di prima linea a base di platino (12-14 settimane) senza irradiazione toracica
    • Registrato una risposta alla chemioterapia di prima linea a base di platino (risposta completa (CR) o risposta parziale (PR) secondo i criteri RECIST, dimostrata dopo il secondo e quarto ciclo di chemioterapia di induzione rispetto ai risultati prima della terapia di induzione)
    • Esami di conferma con la tomografia computerizzata o risonanza magnetica
    • Esame negative del capo con la tomografia computerizzata
    • Essere arruolato e iniziare il trattamento 3-5 settimane dopo l'ultima infusione di chemioterapia di prima linea a base di platino
    • Aspettativa di vita &#8805;4 mesi
    • Performance status secondo la scala ECOG &#61603;2 all'inclusione nello studio
    • Nessuna storia clinica di funzione renale significativamente compromessa o di patologia renale cronica. Deve avere un tasso di filtrazione glomerulare stimato &#8805;50 mL/min, determinato secondo la formula di Cockgraft-Gault
    • Nessuna anormalita' ematologica significativa, incluse le conta leucocitaria &#8805;2,5 &#61620; 103/µl (o granulocitica totale &#8805;1 &#61620; 103/µl), conta linfocitica assoluta &#8805;0,5 &#61620; 103/µl, conta piastrinica &#8805;100 000/µl e tasso di emoglobina &gt;5,5 mmol/L
    • Nessuna anormalita' epatica significativa, inclusa l'alanina amino transaminasi e aspartato amino transaminasi &#61603;2,5 &#61620; il limite superiore del normale (ULN), o &#8804;5 &#61620; ULN in caso di metastasi epatica e bilirubina totale &lt;1,5 &#61620; ULN
    • Nessuna anormalita' elettrolitica significativa, inclusi sodio, potassio e fosforo nel siero entro i limiti normali
    • Esami sierologici entro 4 settimane prima dell'inizio del trattamento dello studio con risultati negativi per il virus dell'epatite C (HCV), virus dell'immunodeficienza umana (HIV) e il virus dell'epatite B (HBV) dimostrati dalla negativita' dell'anticorpo centrale dell'epatite B (HBcAb) e dell'antigene superficiale dell'epatite (HbsAg)
    • Test negativo della gravidanza (&#946;-HCG) sulle urine e la disponibilita' dei soggetti di entrambi i sessi a usare mezzi contraccettivi efficaci per la durata dello studio e per un (1) mese successivamente se in grado di procreare; femmine non allattanti
    E.4Principal exclusion criteria
    • Thoracic radiotherapy, surgery (excluding prior
    diagnostic biopsy) or any investigational drug
    in the 30 days before the start of treatment in
    this study
    • ECG with evidence of active clinically
    significant cardiac disease within 4 weeks prior
    to starting study treatment and/or a cardiac
    stress test with abnormal results in subjects who
    have a history of signficant coronary heart
    disease (MI, angina pectoris, or high risk of
    uncontrolled arrhythmia)
    • Uncontrolled CHF New York Heart
    Association Grade 2-4 or echocardiogram with a left ventricular ejection fraction <45%, or
    other signs of active clinically significant
    cardiovascular disease
    • History of repeated and clinically relevant
    episodes of syncope or other paroxysmal,
    ventricular, or other clinically significant
    arrhythmias unless controlled by an automatic
    internal cardiac defibrillator
    • Uncontrolled hypertension (systolic blood
    pressure &#8805;180 mmHg or diastolic blood
    pressure &#8805;100 mmHg) or hypotension (systolic
    blood pressure &#8804;80 mmHg requiring therapy
    beyond 24 hours)
    • Evidence of active brain metastases
    • No past history of neoplasm other than lung
    carcinoma, except for curatively treated nonmelanoma
    skin cancer, in situ carcinoma of the
    cervix or other cancer curatively treated and
    with no evidence of disease for at least 5 years.
    • Presence of medically significant third space
    fluids such as pleural or pericardial effusions or
    ascites requiring repetitive paracentesis, or
    oedema &#8805;Grade 2 according to the National
    Cancer Institute Common Terminology Criteria
    for Adverse Events (NCI CTCAE) Version 3.0
    • Previous diagnosis of autoimmune disease
    involving major organ system or requirement
    for immunosuppressive therapy
    • History of inflammatory bowel disease or
    history of acute or chronic bowel ischemia
    • Significant active infection
    • Legal incapacity or limited legal capacity that
    would interfer with informed consent or impair
    participation in the study
    • Known hypersensitivity to Tween-80TM, human
    immunoglobulin, CTX, or any of the
    components of study treatments
    • Radioterapia toracica, chirurgia (esclusa precedente biopsia diagnostica) o qualsiasi farmaco sperimentale nei 30 giorni precedenti l'inizio della terapia in questo studio
    • Elettrocardiogramma (ECG) con evidenza di cardiopatia attiva clinicamente significativa entro 4 settimane prima dell'inizio del trattamento dello studio e/o un test di stress cardiaco, con risultati anormali in soggetti con anamnesi di cardiopatia coronarica significativa (infarto miocardico, angina pectoris o rischio elevato di aritmia non controllata)
    • Insufficienza cardiaca congestizia (CHF) non controllata di grado 2-4 secondo la New York Heart Association o ecocardiogramma con una frazione di eiezione ventricolare sinistra &lt;45%, o altri segni di patologia cardiovascolare attiva clinicamente significativa
    • Anamnesi di episodi ripetuti e clinicamente rilevanti di sincope o altre aritmie parossistiche, ventricolari o di altro tipo clinicamente significative, se non controllate da un defibrillatore cardiaco interno automatico
    • Ipertensione non controllata (pressione sanguigna sistolica &#8805;180 mmHg o pressione sanguigna diastolica &#8805;100 mmHg) o ipotensione (pressione sanguigna sistolica &#8804;80 mmHg che richiede la terapia oltre 24 ore)
    • Evidenza di metastasi cerebrali attive
    • Nessuna anamnesi precedente di neoplasia oltre al carcinoma polmonare, eccetto per tumore cutaneo-non melanoma trattato in modo curativo, carcinoma in situ della cervice o altro cancro trattato curativamente e senza evidenza di malattia per almeno 5 anni
    • Presenza di fluidi del terzo spazio medicamente significativi come effusioni pleuriche o pericardiache o asciti che richiedono la paracentesi ripetuta, o edema &#8805;Grado 2 secondo i criteri NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events), Versione 3.0
    • Diagnosi precedente di malattia autoimmunitaria con coinvolgimento di sistema organico principale o necessita' di terapia immunosoppressiva
    • Anamnesi di malattia intestinale infiammatoria o di ischemia intestinale acuta o cronica
    • Infezione attiva significativa
    • Incapacita' legale o capacita' legale limitata che interferirebbe con il consenso informato o comprometterebbe la partecipazione allo studio.
    • Nota ipersensibilizzazione a Tween-80™, immunglobulina umana, ciclofosfamide (CTX) o qualsiasi componente dei trattamenti dello studio
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study will be the number (and percentage) of
    subjects with PFS at 6 months after randomisation.
    L'endpoint primario per questo studio sara' il numero (e la percentuale) dei soggetti con PFS a sei mesi dopo la randomizzazione
    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 Yes
    E.6.4Safety No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    terapia convenzionale
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Fase di follow-up si concludera' con la progressione della malattia seguendo la terapia di seconda linea.
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.1Number 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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 110
    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 Decision2007-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-31
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