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    Summary
    EudraCT Number:2005-004323-18
    Sponsor's Protocol Code Number:AMG70620050130
    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:2006-01-25
    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 number2005-004323-18
    A.3Full title of the trial
    An Open Label Study Treatment Extension Study of AMG 706
    Studio in aperto di estensione del trattamento con AMG706
    A.4.1Sponsor's protocol code numberAMG70620050130
    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 Dompe` SpA
    B.5.2Functional name of contact pointDip. Regolatorio
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli, 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20125
    B.5.3.4CountryItaly
    B.5.4Telephone number02 624112367
    B.5.5Fax number02 29005596
    B.5.6E-mailgbotta@amgendompe.it
    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 nameAMG 706
    D.3.2Product code NA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOther antineoplastic agents
    D.3.9.2Current sponsor codeAMG 706
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number25
    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.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 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 nameAMG 706
    D.3.2Product code NA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOther antineoplastic agents
    D.3.9.2Current sponsor codeAMG 706
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number100
    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
    Treatment of subjects with solid tumors
    Trattamento di soggetti con tumori solidi
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 provide ongoing treatment with AMG 706 monotherapy for those subjects who have completed the planned duration of treatment with AMG 706 on a separate Amgen protocol and demonstrate continuing clinical benefit from AMG 706 therapy or for those who were not eligible to remain on a separate Amgen protocol for reasons other than AMG 706 intolerance, but continue to experience clinical benefit.
    Fornire una continuita' del trattamento in monoterapia con AMG 706 ai soggetti che hanno completato l'intero periodo di trattamento con AMG 706 previsto da un differente protocollo Amgen e dimostrano di continuare a ricevere un beneficio clinico dalla terapia con AMG 706, o a quei soggetti che non presentano i criteri necessari per rimanere in un distinto protocollo Amgen, per ragioni diverse dalla intolleranza al trattamento con AMG 706, ma continuano a ricevere un beneficio clinico.
    E.2.2Secondary objectives of the trial
    To evaluate the safety profile of AMG 706, including adverse events and serious adverse events, for all subjects on continued AMG 706 treatment.
    Valutare il profilo di sicurezza di AMG 706,che include eventi avversi ed eventi avversi seri,per tutti i soggetti durante il trattamento continuativo con AMG 706.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease related · Women and men > 18 years old, with solid tumors, previously treated with AMG 706 on an Amgen protocol · Subject has completed the planned duration of AMG 706 treatment on a separate Amgen protocol and has been evaluated as having stable disease or better (as defined in the previous protocol) or is no longer eligible to continue AMG 706 treatment on a separate Amgen protocol for reasons other than AMG 706 intolerance, but is receiving clinical benefit from AMG 706 in the judgment of the investigator · Subject has received AMG 706 treatment for at least 8 weeks or until the first protocol-specified tumor evaluation, whichever is longer· Subject has been treated with AMG 706 within the last 14 days (if > 14 days since date of last AMG 706 treatment, the subject will require repeat hematology and chemistry laboratory testing and satisfy the criteria in section 4.2.2)· Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained
    Correlati alla malattia· Uomini e donne di eta' &gt; 18 anni con tumori solidi, precedentemente trattati con AMG 706 in un altro protocollo Amgen· Soggetti che hanno completato l'intera durata del trattamento con AMG 706 prevista da un diverso protocollo Amgen e hanno avuto una valutazione di malattia stabile o qualsiasi risposta migliore (come definito nel protocollo precedente), o non presentano piu' i criteri necessari a continuare il trattamento con AMG 706 in un altro protocollo Amgen, per ragioni diverse da intolleranza ad AMG 706, ma stanno ricevendo un beneficio clinico dal trattamento con AMG 706, a giudizio dello sperimentatore· Soggetti che hanno ricevuto il trattamento con AMG 706 per almeno 8 settimane o fino alla prima valutazione del tumore, come specificato dal protocollo, qualsiasi delle due condizioni sia avvenuta per prima· Soggetti che sono stati trattati con AMG 706 nei 14 giorni precedenti (se sono passati piu' di 14 giorni dalla data dell'ultimo trattamento con AMG 706, sara' richiesto al soggetto di ripetere gli esami di laboratorio di ematologia e biochimica e di soddisfare i criteri riportati in sezione 4.2.2)· Etico - Prima che venga eseguita qualsiasi procedura specifica dello studio, e' necessario ottenere un consenso informato scritto, firmato e datato dal soggetto.
    E.4Principal exclusion criteria
    Disease related· Discontinued from an AMG 706 study due to an adverse event considered by the investigator to be related to AMG 706 treatment, including intolerance to AMG 706, or for any other reason that a subject's safety could be compromised with continued AMG 706 treatment· Has been off AMG 706 treatment for > 42 days before study day 1· Participating in any intervening investigational device or drug study(s) between the previous AMG 706 study and this AMG 706 study, or is receiving any investigational agent(s) other than AMG 706· Current uncontrolled hypertension, defined as systolic BP > 145 mm Hg or diastolic BP > 90 mm Hg· Requires additional systemic anticancer therapy for the primary tumorLaboratoryThe following laboratory exclusion criteria are applicable for repeat hematology and chemistry laboratory testing for subjects whose last date of AMG 706 treatment on a previous study has been > 14 days:· absolute neutrophil count (ANC) < 1.5 x 109 /L · platelet count < 100 x 109 /L· hemoglobin < 9 g/dL· serum creatinine > 2.0 mg/dL (> 177 &#956;mol/L) or calculated clearance < 40 mL/min· aspartate aminotransferase (AST) > 2.5 x upper limits of normal (ULN), or AST > 5.0 x ULN if secondary to liver metastasis· total bilirubin > 2 x ULNMedications· Coumarin-type anticoagulants (including warfarin) > 2 mg/day must not be administered within 7 days before study day 1· Currently or previously treated with the following medications within 14 days of study day 1: rifampinphenobarbital · Currently or previously treated with the following medications within 7 days of study day 1:ketoconazoleitraconazoleerythromycinclarithromycinnefazodone closporinetacrolimusany HIV protease inhibitor · Concurrent therapy with St. John's WortMedications which are metabolised by CYP3A4, 2D6 and 2C9 and which have a narrow therapeutic window should be used with caution when given concomitantly with AMG 706, or alternative therapeutic agents with less drug interaction potential should be considered.
    Correlati alla malattia· Sospensione da uno studio AMG 706 dovuta a evento avverso correlato, a parere dello sperimentatore, con il trattamento con AMG 706, inclusa intolleranza ad AMG 706, o per qualsiasi altra ragione per cui la sicurezza del soggetto possa essere compromessa continuando il trattamento con AMG 706· Sospensione del trattamento con AMG 706 da piu' di 42 giorni, prima del giorno 1 dello studio· Partecipazione ad un eventuale studio con un presidio o un farmaco sperimentale tra il precedente studio AMG 706 e questo studio AMG 706 o assunzione di qualsiasi agente sperimentale, diverso da AMG 706 · Ipertensione incontrollata, definita come sistolica &gt; 145 mm Hg o diastolica &gt; 90 mm Hg · Sia necessaria una terapia antitumorale aggiuntiva sistemica per il tumore primarioLaboratorioI seguenti criteri di esclusione di laboratorio sono applicabili agli esami di ematologia e biochimica ripetuti per i soggetti che hanno ricevuto l'ultima dose di AMG 706 piu' di 14 giorni prima nel corso di un precedente studio:· Conta assoluta dei neutrofili (ANC) &lt;1,5 x 109/l· Conta piastrinica &lt; 100 x 109/l · Emoglobina &lt; 9 g/dl.· Creatinina sierica &gt; 2,0 mg/dl (&gt;177mmol/l) o clearence calcolata &lt; 40ml/min· Aspartato amminotrasferasi (AST) &gt; 2,5 x limite normale superiore (ULN), oppure AST &gt; 5,0 x ULN se secondaria a metastasi epatica.· Bilirubina totale &gt; 2 x ULN.Farmaci· Anticoagulanti del genere di Coumarin (inclusa la warfarina) non devono essere somministrati a dosaggio &gt;2 mg/die, da sette giorni prima del giorno 1 dello studio.· Soggetti attualmente o precedentemente trattati con i seguenti farmaci entro 14 giorni dal giorno 1 dello studio :Rifampin o fenobarbitolo · Attualmente o precedentemente trattati con i seguenti farmaci entro 7giorni dal giorno 1 dello studio: ketoconazolo, itraconazolo, eritromicina, claritromicina, nefazodone, ciclosporina, tacrolimus, e qualsiasi inibitore della proteasi di HIV · Terapia concomitante con 'Erba di San Giovanni' Farmaci che sono metabolizzati da CYP 3A4, 2D6, 2C9 e che hanno una finestra terapeutica stretta, dovrebbero essere utilizzati con cautela se somministrati contemporaneamente ad AMG 706, o si dovrebbero tenere in considerazione agenti terapeutici alternativi dotati di un minore potenziale di interazione farmacologica.
    E.5 End points
    E.5.1Primary end point(s)
    Safety (serious adverse events, adverse events, blood pressure, and laboratory parameters), tumor response, and progression-free survival
    Sicurezza (eventi avversi seri, eventi avversi, pressione sanguigna, e parametri di laboratorio), risposta tumorale, e sopravvivenza libera da progressione.
    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.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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 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
    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.1.1Number 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 100
    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 Decision2005-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
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