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    EudraCT Number:2010-021082-74
    Sponsor's Protocol Code Number:U31287-A-U201
    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:2011-12-29
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-021082-74
    A.3Full title of the trial
    Randomized, placebo-controlled, double-blind Phase 1b/2 study of U3-1287 (AMG 888) in combination with erlotinib in EGFR treatment naïve subjects with advanced non-small cell lung cancer (NSCLC) who have progressed on at least one prior chemotherapy.
    Studio randomizzato, controllato verso placebo, in doppio cieco, di fase Ib/II su U3-1287 (AMG 888) in combinazione con Erlotinib nel trattamento di pazienti con cancro polmonare non a piccole cellule in stadio avanzato, che sono andati in contro a progressione dopo almeno una precedente chemioterapia, mai precedentemente sottoposti al trattamento anti-EGFR.
    A.4.1Sponsor's protocol code numberU31287-A-U201
    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.1.3.4CountryUnited 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 supportDAIICHI SANKYO DEVELOPMENT LTD.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Plc
    B.5.2Functional name of contact pointAnna Folcioni
    B.5.3 Address:
    B.5.3.1Street AddressVia Washington 70
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20146
    B.5.4Telephone number02 46571103
    B.5.5Fax number02 80581834
    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 nameU3-1287 (AMG 888)
    D.3.2Product code U3-1287 (AMG 888)
    D.3.4Pharmaceutical form Concentrate for 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 INNMonoclonal antibodies
    D.3.9.1CAS number 1262787-83-6
    D.3.9.2Current sponsor codeU3-1287
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 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 placeboConcentrate for solution for infusion
    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
    Treatment for advanced or metastatic NSCLC in combination with erlotinib in subjects who are epidermal growth factor receptor (EGFR) treatment naïve after failure of at least one prior chemotherapy regimen
    Trattamento dell`€™NSCLC avanzato o metastatico associato a erlotinib di soggetti naïve a trattamento con recettore del fattore di crescita epidermico (EGFR, epidermal growth factor receptor) dopo il fallimento di almeno un precedente trattamento chemioterapico.
    E.1.1.1Medical condition in easily understood language
    NOn-small lung cancer (NSCLC) is a general term for the most common form of solid cancer which affects the lungs
    Tumore al polmone non a piccole cellule e' il termine con cui si indicano le forme piu' comuni di tumori solidi che colpiscono i polmoni
    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 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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
    Italy participates only on Phase II study, therefore only ojectives for this phase are listed (for phase I please see protocol) Primary Objectives phase II · To evaluate progression-free survival (PFS)among all randomized subjects treated with erlotinib in combination with high and low doses of U3-1287 (AMG 888) compared to erlotinib plus placebo. · To evaluate the safety profile of the combination of U3-1287 (AMG 888) and erlotinib.
    L`Italia partecipa solo alla fase II, pertanto si riportano gli obiettivi solo inerenti a questa fase (per fase I vedi protocollo) Obiettivi primari Fase 2 •Valutare la sopravvivenza in assenza progressione (PFS, Progression-Free Survival) tra tutti i soggetti randomizzati sottoposti a trattamento con erlotinib in associazione a U3-1287 (AMG 888) in dosi basse ed elevate rispetto alla somministrazione di erlotinib piu` placebo. •Valutare il profilo di sicurezza dell’associazione di U3-1287 (AMG 888) a erlotinib
    E.2.2Secondary objectives of the trial
    Secondary Objectives phase II · To evaluate overall survival, objective response rate (ORR), duration of response, time to response, time to disease progression, duration of stable disease and disease control rate(complete response [CR] + partial response[PR] + stable disease [SD]) among all randomized subjects treated with erlotinib in combination with high and low doses of U3-1287 (AMG 888) compared to erlotinib plus placebo. · To assess the PK parameters of U3-1287(AMG 888) when combined with erlotinib. · To assess the PK parameters of erlotinib when combined with U3-1287 (AMG 888). · To evaluate the incidence of HAHA formation(anti-U3-1287 [AMG 888] antibodies). · To determine, using the prospective retrospective approach, if a single biomarker hypothesis (based on one or a composite set of biomarkers to be determined, if applicable) can predict a sub-population which can benefit from treatment, as measured by improvement in PFS.
    Obiettivi secondari fase II •Valutare sopravvivenza globale, tasso di risposta obiettiva (ORR, Objective Response Rate), durata della risposta, tempo di risposta, tempo alla progressione della malattia, durata della stabilizzazione della malattia e tasso di controllo della malattia (risposta completa [CR, Complete Response] + risposta parziale [PR, Partial Response] + malattia stabile [SD, Stable Disease]) in tutti i soggetti randomizzati sottoposti a trattamento con erlotinib in associazione a U3-1287 (AMG 888) in dosi basse ed elevate rispetto alla somministrazione di erlotinib piu` placebo. •Valutare i parametri PK di U3-1287 (AMG 888) quando in associazione a erlotinib. •Valutare i parametri PK di erlotinib quando in associazione a U3-1287 (AMG 888). •Valutare il tasso di formazione di HAHA (anticorpi anti-U3-1287 [AMG 888]). •Stabilire, tramite approccio prospettico e retrospettivo, se un’ipotesi con biomarker singolo (basata su un unico biomarker o su un set
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Objectives:research on biomarkers will be conducted to discriminate subjects more likely to benefit from U3-1287 (AMG 888).

    Titolo:“Studio randomizzato, controllato verso placebo, in doppio cieco, di fase Ib/II su U3-1287 (AMG 888) in combinazione con Erlotinib nel trattamento di pazienti con cancro polmonare non a piccole cellule in stadio avanzato, che sono andati in contro a progressione dopo almeno una precedente chemioterapia, mai precedentemente sottoposti al trattamento anti-EGFR.”
    Obiettivi:verrà condotta una ricerca sui marcatori biologici per individuare i soggetti che più probabilmente possono avere dei benefici dal trattamento con U3-1287 (AMG 888)

    E.3Principal inclusion criteria
    Subjects must satisfy all of the following criteria to be included in the study: 1. Men or women ³ 18 years old. 2. Histologically or cytologically confirmed NSCLC with either: - Metastatic disease (Stage IV) OR - Stage IIIB disease not amenable to surgery or curative intent. 3. Disease progression or recurrence following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months)documented by radiographic assessment. 4. Measurable disease per RECIST guidelines Version 1.1. 5. Eastern Cooperative Oncology Group (ECOG)performance status 0 or 1. 6. Hematological function, as follows: - Absolute neutrophil count (ANC)³ 1.5´ 109/L - Platelet count ³ 100 ´ 109/L - Hemoglobin ³ 9 g/dL. 7. Renal function, as follows: - Calculated creatinine clearance³ 60 mL/min using the modified Cockroft-Gault equation or serum creatinine <o= 1.5 x ULN 8. Hepatic function, as follows: - Aspartate aminotransferase (AST) < or = 2.5 X upper limit of normal (ULN) (if liver metastases are present, < 5 X ULN) - Alanine aminotransferase (ALT) < or = 2.5 X ULN (if liver metastases are present,< 5 X ULN) - Alkaline phosphatase < or = 2.5 X ULN (if bone or liver metastases are present, < 5 X ULN) - Bilirubin < or = 1.5 X ULN. 9. Prothrombin time (PT) and partial thromboplastin time (PTT) < or = 1.5 X ULN. 10. Availability of recent (before treatment start) or archival (does not have to be provided by treatment start) tumor specimen (Phase 2 subjects only). 11. For female subjects, must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile, or must use maximally effective birth control during the period of therapy, and be willing to use contraception for 6 months following the last investigational drug dose and have a negative urine or serum pregnancy test upon entry into this study if female subjects of childbearing potential. 12. For male subjects, must be surgically sterile or willing to use a double barrier contraception method upon enrollment, during the course of the study, and for 6 months following the last investigational drug dose. 13. Subjects must be competent and able to comprehend, sign, and date an Independent Ethics Committee- or Institutional Review Board-approved Informed Consent Form (including Health Insurance Portability and Accountability Act authorization, if applicable) before performance of any study-specific procedures or tests.
    Per essere inclusi nello studio, i soggetti devono soddisfare tutti i criteri riportati di seguito: 1.Uomini o donne ≥ 18 anni. 2.NSLC confermato da esame istologico o citologico che evidenzi: –Malattia metastatica (stadio IV) OPPURE –Malattia di stadio IIIB non trattabile chirurgicamente e non curabile. 3.Progressione o recidiva della malattia, successivamente al trattamento dopo l’ultimo regime di trattamento chemioterapico o chemio-radioterapico (completato entro i 12 mesi precedenti), documentata da valutazione radiografica. 4.Malattia misurabile in base ai criteri RECIST, versione 1.1. 5.Valutazione funzionale ECOG (Eastern Cooperative Oncology Group) pari a 0 oppure 1. 6.Funzionalita` ematologica con i seguenti valori: –Conteggio assoluto del neutrofilo (ANC) ≥ 1,5 x 109/l –Conteggio piastrinico ≥ 100 x 109/l –Emoglobina ≥ 9 g/dl. 7.Funzionalita` renale definita dai seguenti valori: –Clearance della creatinina ≥ 60 ml/min calcolata tramite la formula di Cockroft-Gault modificata o creatinina sierica &lt;o= 1.5 x ULN 8.Funzionalita` epatica definita dai seguenti valori: –Aspartato aminotransferasi (AST) &lt; o = 2,5 x ULN (limite superiore della norma) (in presenza di metastasi epatiche &lt; 5 x ULN) –Alanina aminotransferasi (ALT) &lt; o = 2,5 x ULN (in presenza di metastasi epatiche &lt; 5 x ULN) –Fosfatasi alcalina &lt; o = 2,5 x ULN (in presenza di metastasi ossee o epatiche &lt; 5 x ULN) –Bilirubina &lt; o = 1,5 x ULN. 9.Tempo di protrombina (PT) e tempo di tromboplastina parziale (PTT) &lt; o = 1,5 x ULN. 10.Disponibilita` di campioni tumorali recenti (precedenti l’inizio del trattamento) o di archivio, da produrre non necessariamente all’inizio del trattamento (solo per i soggetti della fase 2). 11.I soggetti di sesso femminile devono essere in post-menopausa (assenza di ciclo mestruale da almeno 12 mesi) o essere state sottoposte a sterilizzazione chirurgica, oppure, durante la terapia, devono utilizzare un metodo di contraccezione di massima efficacia ed acconsentire all’uso di un metodo di contraccezione per i 6 mesi successivi all’ultima dose di farmaco sperimentale, nonche`, se soggetti in eta` fertile, sottoporsi a test di gravidanza (urina/siero) al momento dell’accesso allo studio, il cui esito deve necessariamente essere negativo. 12.I soggetti di sesso maschile devono essere stati sottoposti a sterilizzazione chirurgica o acconsentire all’uso di un metodo contraccettivo “a doppia barriera” al momento dell’arruolamento, per la durata dello studio e per i 6 mesi successivi all’ultima dose di farmaco sperimentale. 13.I soggetti devono essere in grado di comprendere, firmare e datare il modulo di consenso informato approvato dal Comitato Etico indipendente (Independent Ethics Committee) o dalla Commissione di Revisione Istituzionale (Institutional Review Board: IRB), inclusa, se applicabile, l’autorizzazione HIPAA (Health Insurance Portability and Accountability Act) prima dell’esecuzione di qualsiasi procedura o test specifico dello studio.
    E.4Principal exclusion criteria
    1. Left ventricular ejection fraction (LVEF) < 45%. 2. Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. 3. More than 2 prior chemotherapy regimens for this indication (Phase 2 subjects only). 4. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for³ 5 years. 5. History of corneal disease. 6. History of interstitial lung disease. 7. Clinically active brain metastases, defined as untreated symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 4 weeks (2 weeks for subjects with a solitary brain lesion amenable to sterotactic radiosurgery) must have elapsed between the end of radiotherapy and study enrollment. 8. Uncontrolled hypertension (diastolic > 100 mmHg or systolic > 140 mmHg). It is permissible for the subject to receive treatment with antihypertensive medication to maintain blood pressure within required parameters. 9. Clinically significant electrocardiogram (ECG) changes that obscure the ability to assess the RR, PR, QT, QTc, and QRS intervals. 10. Ascites or pleural effusion requiring chronic medical intervention. 11. Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure (New York Heart Association >Class II), unstable angina, or unstable cardiac arrhythmia requiring medication. 12. Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment or treatment with small molecule tyrosine kinase inhibitors(TKIs) within 2 weeks before study drug treatment. Prior and concurrent use of hormone replacement therapy is permitted. 13. Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment. Radiation treatment to all sites of measureable disease unless progression is documented after radiation. No target lesion should be selected within the previously irradiated field unless there was progression at that lesion following radiation. 14. Participated in clinical drug trials within 4 weeks (2 weeks for small molecule TKIs) before study drug treatment. Current participation in other investigational procedures. 15. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. 16. History of hypersensitivity to any of the study drugs or to any excipients. 17. Concurrent use of CYP3A4 inducers or inhibitors. 18. Any known pre-existing condition including substance abuse that could interfere with subject’s participation in and completion of the protocol.
    1.Frazione di eiezione ventricolare sinistra (LVEF) &lt; 45%. 2.Precedente trattamento mirato al EGFR, terapia anti-HER2, anti-HER3 o anti-HER4. 3.Piu` di 2 precedenti trattamenti chemioterapici effettuati per questa indicazione (solo per i soggetti della fase 2). 4.Neoplasie maligne pregresse, ad eccezione di cancro della pelle non melanoma trattato adeguatamente, malattia in situ trattata con intento curativo o altri tumori solidi sottoposti a trattamento curativo senza evidenza di malattia per almeno 5 anni. 5.Storia clinica di patologie corneali pregresse. 6.Storia clinica di malattie interstiziali polmonari pregresse. 7.Metastasi cerebrali clinicamente attive, definite come sintomatiche non trattate o che richiedano terapia con steroidei o anticonvulsivanti per il controllo dei sintomi associati. I soggetti con metastasi cerebrali trattate non piu` sintomatiche che non richiedono trattamento con farmaci steroidei possono essere inclusi nello studio se non presentano gli effetti tossici acuti della radioterapia. Deve trascorrere un periodo minimo di 4 settimane (2 settimane per soggetti con una sola lesione cerebrale riconducibile a radiochirurgia stereotassica) tra la fine del trattamento radioterapico e l’arruolamento allo studio. 8.Ipertensione incontrollata (diastolica &gt; 100 mmHg o sistolica &gt; 140 mmHg). E` ammesso che il soggetto riceva trattamento con farmaci antipertensivi per mantenere la pressione sanguigna entro i parametri richiesti. 9.Alterazioni clinicamente significative dell’elettrocardiogramma (ECG) che compromettano la capacita` di valutazione degli intervalli RR, PR, QT, QTc e QRS. 10.Ascite o versamento pleurico che richieda trattamento medico cronico. 11.Infarto miocardico fino a 1 anno prima dell’arruolamento, scompenso cardiaco congestizio sintomatico (New York Heart Association &gt; Classe II), angina instabile o aritmia cardiaca instabile che richieda trattamento farmacologico. 12.Trattamento con terapia anticancro, terapia basata su anticorpi, terapia ormonale o con retinoidi fino a 4 settimane prima del trattamento con il farmaco dello studio o trattamento con nitrosouree o mitomicina C fino a 6 settimane prima del trattamento con il farmaco dello studio o trattamento con piccole molecole agenti come inibitori delle tirosin-chinasi (TKI, Tyrosine Kinase Inhibitors) fino a 2 settimane prima del trattamento con il farmaco dello studio. E` ammesso l’uso della terapia sostitutiva ormonale prima e durante il trattamento con il farmaco dello studio. 13.Radioterapia a fini terapeutici o intervento chirurgico rilevante fino a 4 settimane prima del trattamento con il farmaco dello studio o radioterapia palliativa fino a 2 settimane prima del trattamento con il farmaco dello studio. Trattamento radioterapico di tutti i siti con malattia misurabile, a meno che vi sia una progressione documentata in seguito alla radioterapia. Nessuna lesione target selezionata all’interno dell’area precedentemente irradiato a meno che vi sia miglioramento della lesione in seguito alla radioterapia. 14.Partecipazione a sperimentazioni cliniche farmacologiche fino a 4 settimane prima del trattamento con il farmaco dello studio (2 settimane per il trattamento con piccole molecole agenti come TKI). Partecipazione contemporanea ad altre procedure sperimentali. 15.Infezione incontrollata che richieda trattamento con antibiotici per via endovenosa, antivirali o antimicotici, infezione da HIV (human immunodeficiency virus: virus da immunodeficienza umana) conclamata o infezione da epatite B o C attiva. 16.Anamnesi di ipersensibilita` a uno qualsiasi dei farmaci dello studio o ad uno qualsiasi degli eccipienti. 17.Uso concomitante di induttori o inibitori del CYP3A4. 18.Condizione preesistente nota che includa l’abuso di sostanze che potrebbero interferire con la partecipazione del soggetto e il completamento del protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    For both Phase 1b and Phase 2 · Treatment-emergent AEs · Clinically significant or ≥ grade 3 events according to National Cancer Institute (NCI)Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 in safety laboratory tests, physical examinations, ECGs, echocardiograms, or vital signs For Phase 1b only · Incidence of DLTs (used to identify RP2D, if applicable) For Phase 2 only · PFS
    Per le fasi 1b e 2 •Eventi avversi (AE) insorti in seguito al trattamento •Eventi clinicamente significativi o eventi pari o superiori al grado 3 secondo i criteri NCI CTAE (National Cancer Institute Common Terminology Criteria for Adverse Events) versione 4.0 nei test di laboratorio sulla sicurezza, negli esami obiettivi, negli ECG, negli ecocardiogrammi o nei segni vitali Solo per la fase 1b •Incidenza delle DLT (utilizzate per identificare l’RP2D, se applicabile) Solo per la fase 2 •PFS
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    For both Phase 1b and Phase 2 · PK parameters (Cmin, Cmax and AUC) of U3-1287 (AMG 888) when combined with erlotinib · PK parameters (Cmin, Cmax and AUC) of erlotinib when combined with U3-1287(AMG 888) · HAHA profile for U3-1287 (AMG 888) · Best overall tumor response For Phase 2 only · Overall survival (OS) · ORR · Duration of response · Time to response · Duration of stable disease (SD) · Time to disease progression (TTP) · Disease control rate (CR+PR+SD)
    Sia per fase I che per fase II: 1) parametri di PK (Cmin, Cmax, AUC) di U3-1287 in associazione con erlotinib 2) Parametri di PK (Cmin, Cmax, AUC) di erlotinib quando associato a U3-1287 3) Profilo HAHA per U3-1287 4)Migliore risposta totale del tumore Solo per la fase II: 1)sopravvivenza totale 2) ORR 3) Durata della risposta 4) tempo alla risposta 5) durata di malattia stabile 6) controllo del tasso di malattia(CR+PR+SD)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    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) 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 trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 Yes
    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
    La durata dello studio e' prevista fino al decesso di tutti i soggetti o per un periodo minimo di 12 mesi dalla randomizzazione dell’ultimo soggetto nella fase 2, quale delle due condizioni si verifichi per prima.
    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 months23
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 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 195
    F.4.2.2In the whole clinical trial 210
    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 Decision2011-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-06
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