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    Summary
    EudraCT Number:2009-012152-24
    Sponsor's Protocol Code Number:ABT4710n
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-07-16
    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 number2009-012152-24
    A.3Full title of the trial
    A Phase II, multicenter, randomized, controlled, open-label study of the safety, efficacy and pharmacokinetics of ABT-263 in combination with dose-intensive rituximab or dose-intensive rituximab alone in previously untreated patients with B cell, chronic lymphocytic leukemia (CLL).
    Sperimentazione di fase 2, multicentrica, randomizzata, controllata, in aperto, volta a verificare la sicurezza, l`€™efficacia e la farmacocinetica di ABT-263 in associazione con rituximab dose-intensive o di rituximab dose-intensive da solo in pazienti con leucemica linfocitica cronica (CLL) a cellule B non precedentemente trattati.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of ABT-263 in Combination With Dose-Intensive Rituximab, or Dose-Intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)
    Sperimentazione di ABT-263 in associazione con Rituximab dose-intensive o di Rituximab dose-intensive da solo in pazienti con leucemia linfocitica cronica (CLL) a cellule B non precedentemente trattati.
    A.3.2Name or abbreviated title of the trial where available
    FRANC
    FRANC
    A.4.1Sponsor's protocol code numberABT4710n
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN01087151
    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 SponsorAbbott GmbH & Co. KG
    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 supportGenentech Inc
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAbbott Laboratories
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Laboratories
    B.5.2Functional name of contact pointClinical Trials Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)162864475
    B.5.5Fax number+44(0)1628644330
    B.5.6E-maileuclinicaltrials@abbott.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.3.2Product code ABT-263
    D.3.4Pharmaceutical form Oral solution
    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 INNNavitoclax
    D.3.9.2Current sponsor codeABT-263
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 MABTHERA*EV 1FL 50ML 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE 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 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 INNRituximab
    D.3.9.1CAS number 174722-31-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    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 No
    D.IMP: 3
    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.3.2Product code ABT263
    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 INNNavitoclax
    D.3.9.2Current sponsor codeABT-263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 No
    D.IMP: 4
    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.3.2Product code ABT-263
    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 INNNavitoclax
    D.3.9.2Current sponsor codeABT-263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 No
    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
    B-CELL, CHRONIC LYMPHOCYTIC LEUKEMIA (CLL).
    Leucemia linfocitica cronica a cellule B (CLL).
    E.1.1.1Medical condition in easily understood language
    To evaluate safety,efficacy,pharmacokinetics of rituximab dose-intense regimen in monotherapy and combination with ABT263 in previously untreated pts with B-cell ChronicLymphocytic Leukemia
    Verificare sicurezza,efficacia,farmacocinetica di rituximab a dose intensa,da solo o associato ad ABT263,in soggetti con Leucemia Linfocitica Cronica a cellule B nn precedentemente trattati
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008956
    E.1.2Term Chronic lymphatic leukaemia
    E.1.2System Organ Class 100000004864
    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 ABT-263 when given according to two different regimens in combination with doseintense rituximab in previously untreated patients with B-cell CLL, as measured by progression-free survival (PFS) based on investigator assessments.
    Determinare l’efficacia di ABT-263 somministrato secondo due differenti regimi in combinazione con rituximab “dose-intense” in soggetti non precedentemente trattati affetti da LLC a cellule B, misurata come sopravvivenza libera da progressione (PFS) basata su valutazione dello sperimentatore.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of dose-intense, rituximab monotherapy in previously untreated patients with B-cell CLL • To evaluate the efficacy of ABT-263 when given according to two different regimens in combination with dose-intense rituximab in previously untreated patients with B-cell CLL • To compare the pharmacokinetics of ABT-263 and rituximab when administered alone to that when the two therapies are administered in combination • To investigate the effects of rituximab on the pharmacokinetics of ABT-263 and the effects of ABT-263 on rituximab pharmacokinetics • To evaluate the efficacy of rituximab monotherapy either alone or when administered with ABT-263 according to two different regimens in previously untreated patients with B-cell CLL • To evaluate the safety and tolerability of ABT-263 when given according to two different regimens in combination with dose-intense rituximab in previously untreated patients with B-cell CLL.
    Valut l'eff della monoterapia di rituximab dose-intense in sogg non prec trattati affetti da leucemia linfocitica cronica (LLC) a cellule B.Valut l'eff di ABT-263 somm secondo due differenti regimi in comb con rituximab dose-intense in soggetti non prec trattati affetti da leucemia linfocitica cronica (LLC) a cellule B.Confrontare la farmacocinetica di ABT-263 e rituximab somm da solo rispetto alle due terapie somm in combinazione.Indagare gli effetti di rituximab sulla farmacocinetica di ABT-263 e gli effetti di ABT-263 sulla farmacocinetica di rituximab.Valut l'eff della monoterapia di rituximab sia da solo che somm con ABT-263 in accordo a due differenti regimi in soggetti non precedentemente trattati affetti da leucemia linfocitica cronica (LLC) a cellule B.Valutare la sicurezza e la tollerabilita' di ABT-263 somm secondo due differenti regimi in combinazione con rituximab dose-intense in soggetti non prec trattati affetti da leucemia linfocitica cronica (LLC) a cellule B
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:Amd.4
    Date:2011/01/12
    Title:Predictive biomarker studies - refer section 3.2.4 of the protocol.
    Objectives:Predictive biomarker studies - refer section 3.2.4 of the protocol.

    FARMACOCINETICA/FARMACODINAMICA:
    Vers:Amd.4
    Data:2011/01/12
    Titolo:Studi Biomarcatori Predittivi - si veda la sezione 3.2.4 del Protocollo.
    Obiettivi:Studi Biomarcatori Predittivi - si veda la sezione 3.2.4 del Protocollo.

    E.3Principal inclusion criteria
    • Previously untreated, CD20-positive B-cell CLL • ECOG performance status of 0 or 1 • Life expectancy > 6 months • Willingness and capability to be accessible for follow-up until study termination or death • For patients of reproductive potential (both males and females), use of a reliable means of contraception. Additional inclusion criterion: patients must be considered not to be appropriate to receive treatment with fludarabine/cyclophosphamide/rituximab chemioimmunotherapy, as determined by the clinical judgment of the investigator.
     Il soggetto deve essere affetto da leucemia linfocitica cronica a cellule di tipo B CD20-positiva non precedentemente trattata.  Il soggetto con performance status ECOG (Eastern Cooperative Oncology Group) di 0 o 1.  Il soggetto deve avere un’aspettativa di vita &gt; 6 mesi.  Il soggetto deve avere la volonta` e la capacita` di essere raggiungibile per follow-up fino alla fine della sperimentazione o al decesso  Il Soggetto potenzialmente fertile (sia uomo che donna) deve fare uso di un mezzo contraccetivo affidabile. Criterio d’inclusione addizionale: in base al parere clinico dello sperimentatore la chemioterapia a base di fludarabine/cyclophosphamide/rituximab è ritenuta una terapia non appropriata per i soggetti.
    E.4Principal exclusion criteria
    • Prolymphocytic leukemia • Richter`s transformation to an aggressive B-cell malignancy (e.g., DLBCL) • Prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of progression at baseline • Patients with a history of other malignancies within 2 years prior to study entry except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, low-grade, localized prostate cancer treated surgically with curative intent or one that carries a good prognosis, in situ ductal carcinoma of the breast treated with lumpectomy alone with curative intent • Prior treatment with rituximab, ABT-263 or other pro-apoptotic agents • Current or recent (within the 28 days prior to initiation of study treatment) participation in another experimental drug study • Major surgical procedure (excluding lymph node biopsy) or significant traumatic injury within 28 days prior to treatment onset or anticipation of the need for major surgery during the course of the study • Active infection requiring parenteral antibiotics or antiviral or antifungal agents at the onset of study treatment • Receipt of primary or booster vaccination with live-virus vaccines for up to 6 months prior to initiation of study treatment • Patients receiving therapeutic anticoagulation with heparin or warfarin or patients receiving any drugs or herbal supplements that are known to inhibit platelet function (including low-dose aspirin) within 7 days of the first dose of ABT-263. Note: Patients receiving low-dose anticoagulation for the purpose of maintaining central venous catheter patency are eligible. • Patients who have an inherited or acquired bleeding diathesis, including (but not limited to) hemophilia or immune or thrombotic thrombocytopenic purpura, or who have had an underlying condition that predisposes to abnormal bleeding (e.g., peptic ulcer disease) within 1 year prior to the first dose of ABT-263 • Patients with a history of refractoriness to platelet transfusions • Clinically significant cardiovascular disease • Known human immunodeficiency virus (HIV) infection, seropositivity for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or RNA • Pregnancy or breastfeeding • Concurrent (or within 7 days prior to the first dose of study treatment) systemic corticosteroid therapy except some low-dose corticosteroid therapies • History of other disease, metabolic dysfunction, physical or laboratory finding(s) giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, might affect interpretation of the results of the study or render the patient at high risk from treatment complications • History of anaphylaxis, allergic reaction, or hypersensitivity to sulfites (sodium metabisulphite is included in study drug formulation) • Any contraindication to alcohol ingestion (study drug formulation includes approximately 15% ethanol)
     Il soggetto presenta diagnosi di Leucemia prolinfocitica  Il soggetto presenta una trasformazione Richter a neoplasia aggressiva a cellule B (es. DLBCL: linfoma diffuso a grandi cellule B)  Precedente radioterapia su lesione/i utilizzata/e per valutare la risposta a meno che quella/e lesione/i presenti/ino una chiara evidenza di progressione al baseline  Il soggetto ha una storia di altri tumori maligni entro 2 anni precedenti l’entrata nella sperimentazione, eccetto carcinoma in situ della cervice adeguatamente trattato, carcinoma basale o squamoso della pelle, cancro della prostata a basso grado localizzato trattato chirurgicamente con intento curativo o con buona prognosi, carcinoma duttale in situ della mammella trattato con lumpectomia con intento curativo  Precedente terapia con Rituximab, ABT-263 o altri agenti pro-apoptotici  Attuale o recente partecipazione ad un’altra sperimentazione con medicinale sperimentale (entro i 28 giorni precedenti l’inizio della terapia di sperimentazione)  Intervento chirurgico importante (esclusa biopsia dei linfonodi) o incidente traumatico significativo entro 28 giorni prima dell’inizio della terapia di sperimentazione o necessità preventivamente nota di un intervento chirurgico importante durante il corso della sperimentazione  Infezione attiva che richieda antibiotici parentali o agenti antivirali o antifungini all’inizio della terapia di sperimentazione  Vaccinazione primaria o di richiamo con vaccini a base di virus vivo entro i sei mesi precedenti l’inizio della terapia di sperimentazione  Soggetti che ricevano terapia anticoagulante con eparina o warfarina o che ricevano qualunque farmaco o intergratore erboristico noto come inibitore della funzione piastrinica (inclusa l’aspirina a basse dosi) entro i 7 giorni precedenti la prima dose di ABT-263. Nota: i soggetti che ricevano una bassa dose di anticoagulante allo scopo di mantenere la pervieta` del catetere venoso centrale sono eleggibili.  Soggetti che abbiano una diatesi emorragica ereditaria o acquisita inclusa (ma non limitata a) emofilia o porpora trombocitopenica trombotica o immune o che abbiano avuto una condizione di base che abbia predisposto ad un sanguinamento anormale (ad esempio ulcera peptica) entro un anno precedente alla prima dose di ABT-263.  Soggetti con una storia di refrattarietà a trasfusioni di piastrine  Malattia cardiovascolare clinicamente significativa  Infezione nota da virus dell’immunodeficienza umana (HIV), sieropositivita` per l’antigene di superficie dell’epatite B (HbsAg) o anticorpi o RNA per il virus dell’epatite C (HCV).  Gravidanza o allattamento  Terapia sistemica, a base di corticosteroidi eccetto alcune terapie a basso dosaggio di corticosteroidi, concomitante alla terapia di sperimentazione (o entro 7 giorni prima dell’assunzione della prima dose di terapia di sperimentazione)  Storia di altre malattie, disfunzione metabolica, risultati di laboratorio o fisici che portino ad un ragionevole sospetto di malattia o condizione che sconsigli l’uso di un medicinale sperimentale, che potrebbe influire sull’interpretazione dei risultati della sperimentazione, o mettere il soggetto ad alto rischio di complicanze dovute alla terapia con il medicinale sperimentale.  Storia di anafilassi, reazione allergica, o ipersensibilita` ai solfiti (il sodio metabisolfito e` incluso nella formulazione del medicinale sperimentale)  Qualunque controindicazione all’ingestione di alcol (la formulazione del medicinale sperimentale include approssimativamente il 15% di etanolo)
    E.5 End points
    E.5.1Primary end point(s)
    the primary efficacy endpoint in PFS, defined as the time from randomization to the first occurrence of progression or relapse (as defined in Appendix E of the protocol) as assessed by the investigator or death on study.
    L`end-point primario di efficacia è la sopravivvenza libera da progressione definita come il tempo trascorso dalla randomizzazione alla prima manifestazione di progressione, recidiva (come definita nell’appendice E del protocollo) in base al giudizio dello sperimentatore o decesso durante lo studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from First Patient In [FPI])
    Tempo trascorso: dalla randomizzazione alla prima manifestazione di progressione, recidiva o decesso durante la sperimentazione (approssimativamente 40 mesi dal primo soggetto entrato nella sperimentazione)
    E.5.2Secondary end point(s)
    • Overall response rate (ORR) [ Time Frame: Approximately 40 months from FPI ] • Duration of response [ Time Frame: Approximately 40 months from FPI ] • Complete response (CR) rate [ Time Frame: Approximately 40 months from FPI ] • Progression-free survival as assessed by a blinded, independent review [ Time Frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from FPI) ] • ORR as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ] • Duration of response as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ] • CR rate as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ] • Overall survival (OS) [ Time Frame: From randomization until death due to any cause (approximately 4 years after Last Patient In) ]
     Tasso di risposta globale (ORR) [tempo trascorso: approssimativamente 40 mesi dal primo soggetto entrato nella sperimentazione]  Durata della risposta [tempo trascorso: approssimativamente 40 mesi dal primo soggetto entrato nella sperimentazione]  Tasso di risposta completa (CR) [tempo trascorso: approssimativamente 40 mesi dal primo soggetto entrato nella sperimentazione]  Sopravivvenza libera da progressione in base a valutazioni in cieco condotte da un organismo di controllo indipendente (tempo trascorso: dalla randomizzazione alla prima manifestazione di progressione, recidiva o decesso durante la sperimentazione (tempo trascorso: approssimativamente 40 mesi dal primo soggetto entrato nella sperimentazione)  Tasso di risposta globale (ORR) in base a valutazioni in cieco condotte da un organismo di controllo indipendente (tempo trascorso: approssimativamente 40 mesi dal primo soggetto entrato nella sperimentazione)  Durata della risposta in base a valutazioni in cieco condotte da un organismo di controllo indipendente [tempo trascorso: approssimativamente 40 mesi dal primo soggetto entrato nella sperimentazione]  Tasso di risposta completa (CR) in base a valutazioni in cieco condotte da un organismo di controllo indipendente [tempo trascorso: approssimativamente 40 mesi dal primo soggetto entrato nella sperimentazione]  Sopravvivenza Globale (OS) [tempo trascorso: dalla randomizzazione fino al decesso per qualsiasi causa (approssimativamente 4 anni dopo l’ultimo soggetto entrato nella sperimentazione]
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 40 months from FPI (first patient in)
    Approssimativamente 40 mesi dal 1°soggetto entrato nella sperimentazione.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Argentina
    Australia
    Brazil
    Israel
    Russian Federation
    Ukraine
    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
    The end of the trial is defined as the date of the last subject`s last scheduled visit or the actual date of follow-up contact, whichever is longer.
    La conclusione della sperimentazione è definita come la data dell`ultima visita dell`ultimo soggetto o la data dell`ultimo follow up, qualora posteriore.
    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 months59
    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 months68
    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.1.2.1Number of subjects for this age range: 57
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 120
    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)
    No sponsored therapy will be provided once the study is completed. However, any subjects who remain on study treatment at the time of the conclusion of the study, i.e., patients in Arm C receiving ABT-263 until disease progression, may be eligible to continue study treatment according to a companion protocol . Upon completion of the study, the subject will be treated in accordance with the investigator`s best clinical judgement.
    Al completamento della sperimentazione non sarà fornita nessuna terapia dallo Sponsor.I soggetti che continueranno la terapia di studio al momento del completamento della sperimentaz,cioè i soggetti nel braccio C che ricevono ABT263 fino a progressione della malattia,potrebbero essere eleggibili per continuare la terapia di studio,secondo un ``companion protocol``.Al completamento della sperimentazione il soggetto sarà trattato in accordo al giudizio clinico dello sperimentatore.
    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 Decision2010-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-02-06
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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