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    Summary
    EudraCT Number:2011-003832-30
    Sponsor's Protocol Code Number:11-PIR-11
    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:2012-08-07
    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 number2011-003832-30
    A.3Full title of the trial
    The BEACON Study (BrEAst Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician's Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and Capecitabine
    Studio BEACON (BrEAst Cancer Outcomes with NKTR-102, Esiti del cancro al seno con NKTR-102): Studio di Fase 3, multicentrico, randomizzato, in aperto su NKTR-102 rispetto al Trattamento di scelta del medico (TPC) nelle pazienti affette da cancro al seno localmente recidivante o metastatico precedentemente trattate con un'antraciclina, un taxano e capecitabina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare NKTR-102 (also called the ''study drug'') with standard treatments for breast cancer (also called ''treatment of physician's choice'').
    Studio per comparare NKTR-102 (chiamato anche ''farmaco in studio'') con lo standard trattamenti per il cancro al seno (detto anche ''trattamento del medico scelta '').
    A.3.2Name or abbreviated title of the trial where available
    BEACON
    BEACON
    A.4.1Sponsor's protocol code number11-PIR-11
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01492101
    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 SponsorNEKTAR THERAPEUTICS
    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 supportNektar Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles Contact Center
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Addressna
    B.5.3.2Town/ cityna
    B.5.3.3Post codena
    B.5.3.4CountryItaly
    B.5.4Telephone number+1 862 261 3634
    B.5.5Fax numberna
    B.5.6E-mailna.na@quintiles.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.3.1Product nameNKTR-102
    D.3.2Product code na
    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.3.9.1CAS number 1193151-06-2
    D.3.9.2Current sponsor codeNKTR-102
    D.3.9.3Other descriptive nameNKTR-102
    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.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 Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.9.1CAS number 33069-62-4
    D.3.9.3Other descriptive namePaclitaxel albumin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    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 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 Halaven
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 INNERIBULIN MESYLATE
    D.3.9.1CAS number 441045-17-6
    D.3.9.4EV Substance CodeSUB31126
    D.3.10 Strength
    D.3.10.1Concentration unit mCi/ml millicurie(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number440
    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 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 Gemcitabine
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 INNGEMCITABINE HYDROCHLORIDE
    D.3.9.1CAS number 122111-03-9
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    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: 5
    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 Navelbine
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Emulsion 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 INNVINORELBINE TARTRATE
    D.3.9.1CAS number 125317-39-7
    D.3.9.4EV Substance CodeSUB20777
    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 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: 6
    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 Docetaxel
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Emulsion 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 INNANHYDROUS DOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.4EV Substance CodeSUB22289
    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 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: 7
    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 Paclitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    Locally Recurrent Breast Cancer, Metastatic Breast Cancer
    cancro della mammella localmente ricorrente, il cancro al seno metastatico
    E.1.1.1Medical condition in easily understood language
    Metastasic Breast Cancer (MBC)
    Cancro alla mammella metastatico
    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 10057654
    E.1.2Term Breast cancer female
    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 10055113
    E.1.2Term Breast 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 10006198
    E.1.2Term Breast cancer recurrent
    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 compare the Overall Survival (OS) of patients who receive NKTR-102
    given once every 21 days to patients who receive TPC selected from the
    following list of seven single-agent intravenous therapies: eribulin,
    ixabepilone, vinorelbine, gemcitabine, paclitaxel,
    docetaxel or nab-paclitaxel.
    Per confrontare la sopravvivenza globale (OS) delle pazienti che ricevono NKTR-102
    somministrato una volta ogni 21 giorni a pazienti che ricevono TPC selezionato dalla
    seguente elenco di sette terapie endovenose singolo agente: Eribulin,
    ixabepilone, vinorelbina, gemcitabina, paclitaxel,
    docetaxel o paclitaxel-nab.
    E.2.2Secondary objectives of the trial
    To compare the Objective Response Rate (ORR) per Response
    Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (hereafter
    referred to as RECIST)
    • To compare progression-free survival (PFS)
    • To compare the Clinical Benefit Rate (CBR) (the proportion of patients
    having complete response (CR), partial response (PR), or
    stable disease (SD) for at least 6 months)
    • To compare Duration of Response (DoR)
    • To determine the safety profiles of NKTR-102 and Treatment of
    Physician's Choice (TPC) (including Grade 3 and higher toxicities,
    incidence of dose reductions and dose intensity)
    • To compare health-related quality of life (QoL) using the QLQ-C30
    questionnaire with the BR23 subscale
    • To obtain pharmacokinetic (PK) data (in selected patients randomized
    to NKTR-102,To evaluate the pharmacoeconomic implications of NKTR-102
    Per confrontare il tasso di risposta oggettivo (ORR) per risposta Criteri di valutazione nei tumori solidi (RECIST) versione 1.1
    Per confrontare sopravvivenza libera da progressione (PFS)
    Per confrontare il tasso di beneficio clinico (CBR) (la proporzione di pazienti
    con risposta completa (CR),risposta parziale (PR),o
    malattia stabile (SD) per almeno 6 mesi),confrontare durata della risposta (DOR),determinare i profili di sicurezza di NKTR-102 e di trattamento di
    Scelta del medico (TPC) (anche di grado 3 e superiori tossicità,
    incidenza di riduzioni della dose e l'intensità della dose),confrontare la salute-qualità della vita (QoL) utilizzando il QLQ-C30questionario con il sottoscala BR23,ottenere farmacocinetica (PK) i dati (in pazienti selezionati randomizzati
    a NKTR-102Per valutare lePer valutare le implicazioni farmacoeconomici della terapia NKTR-102
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient is an adult female with histologically or cytologically confirmed
    carcinoma of the breast for whom single-agent cytotoxic chemotherapy
    is indicated
    •Patient can have either measurable or non-measurable disease by
    RECIST.
    •Patient has received prior therapy (administered in the neoadjuvant,
    adjuvant and/or metastatic setting) with an anthracycline, a taxane and
    capecitabine
    •Patient has minimum of 2 and a maximum of 5 prior cytotoxic
    chemotherapy regimens with the last dose administered within 6
    months. A minimum of two chemotherapy regimens had to be for locally
    recurrent and/or metastatic disease. All therapy received prior to a
    diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated
    adjuvant therapy following a second resection) is counted as one
    regimen.
    •Patient has Eastern Cooperative Oncology Group (ECOG) performance
    status of 0 or 1.
    •Adequate hematopoietic, liver and kidney function
    Il paziente è una femmina adulta con citologicamente o istologicamente confermata
    carcinoma della mammella per cui singolo agente chemioterapia citotossica
    è indicata
    • Il paziente può presentare una malattia misurabile o non misurabile dal
    RECIST.
    • Il paziente ha ricevuto una precedente terapia (somministrato in neoadiuvante,
    adiuvante e / o della malattia metastatica) con un antraciclina, un tassano e
    capecitabina
    • Il paziente ha minimo di 2 e un massimo di 5 citotossica
    regimi chemioterapici con l'ultima dose somministrata entro 6
    mesi. Un minimo di due regimi chemioterapici dovuto essere per il locale
    recidivante e / o malattia metastatica. Tutti hanno ricevuto la terapia prima di una
    diagnosi di malattia metastatica (ad esempio, neoadiuvante, adiuvante o ripetute
    La terapia adiuvante dopo una resezione secondo) viene conteggiato come uno
    regime.
    • Il paziente ha Eastern Cooperative Oncology Group (ECOG) le prestazioni
    stato di 0 o 1.
    • Adeguata ematopoietico, funzionalità epatica e renale
    E.4Principal exclusion criteria
    Patient with chemotherapy within 21 days, radiotherapy within 14
    days, biological therapy with 14 days, hormonal therapy within 7 days
    and investigational therapy within 21 days prior to randomization.
    •Patient with any major surgery within 28 days prior to randomization.
    •Patient with concurrent use of biologic agents for the treatment of
    cancer including antibodies or any investigational agent(s).
    •Patient with prior treatment for cancer with a camptothecin derivative.
    •Patient with chronic or acute GI disorders resulting in diarrhea of any
    severity grade; patients who are using chronic anti-diarrheal supportive
    care to control diarrhea in the 28 days prior to randomization.
    •Patient received pharmacotherapy for hepatitis B or C, tuberculosis or
    HIV.
    •Patient with known cirrhosis diagnosed with Child-PUGH Class A or
    higher liver disease.
    •Patient with prior malignancy (other than breast cancer) except for
    non-melanoma skin cancer and carcinoma in situ (of the cervix or
    bladder), unless diagnosed and definitively treated more than 5 years
    prior to randomization.
    •Patient requiring daily use of oxygen supplementation in the 28 days
    prior to randomization.
    •Patients with significant cardiovascular impairment
    Paziente con la chemioterapia entro 21 giorni, radioterapia entro 14
    giorni, la terapia biologica con 14 giorni, la terapia ormonale entro 7 giorni
    e la terapia sperimentale entro 21 giorni prima della randomizzazione.
    • Paziente con qualsiasi intervento chirurgico importante entro 28 giorni prima della randomizzazione.
    • paziente con l'uso concomitante di agenti biologici per il trattamento dei
    cancro, compresi gli anticorpi o di qualsiasi farmaco sperimentale (s).
    • Paziente con un precedente trattamento per il cancro con un derivato camptotecina.
    • pazienti affetti da disturbi gastrointestinali croniche o acute con conseguente diarrea di qualsiasi
    grado di gravità; pazienti che stanno assumendo anti-diarrea cronica di supporto
    cura per controllare la diarrea nei 28 giorni prima della randomizzazione.
    • farmacoterapia paziente ha ricevuto per l'epatite B o C, la tubercolosi o
    HIV.
    • paziente con cirrosi noto con diagnosi di Child-Pugh classe A o
    malattie epatiche superiore.
    • Paziente con tumore maligno prima (diverso da cancro al seno) ad eccezione di
    non-melanoma, cancro della pelle e carcinoma in situ (o della cervice
    vescica), a meno diagnosticati e trattati in via definitiva più di 5 anni
    prima della randomizzazione.
    • paziente che richiede l'uso quotidiano della supplementazione di ossigeno nei 28 giorni
    prima della randomizzazione.
    • I pazienti con una insufficienza cardiovascolare
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is OS
    over all survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survival is defined as the time from the date of randomization to
    death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or
    alive at the time of analysis will be censored at the time they were last
    known alive.
    La sopravvivenza globale è definito come il tempo dalla data di randomizzazione alla
    morte per qualsiasi causa. I pazienti saranno seguiti fino alla loro data di morte o fino alla chiusura finale del database. I pazienti che sono perso-to-follow-up o
    vivi al momento dell'analisi sarà censurato nel momento in cui sono stati l'ultima
    noto vivo.
    E.5.2Secondary end point(s)
    ORR
    • PFS
    • CBR
    • DoR
    • Incidence and severity of treatment-emergent adverse events (TEAEs),
    laboratory abnormalities, targeted symptoms (including diarrhea and
    neuropathy); incidence of dose reductions; dose intensity
    • QLQ-C30 individual scale, overall score and BR23 score value and
    change over the time of study participation
    • Derived PK parameters, including Cmax, AUC, time to Cmax (Tmax), V,
    elimination t½ and CL, with an exploratory analysis regarding possible
    correlation to various baseline characteristics (eg, age and UGT1A1
    status)
    • Selected measures of health care utilization
    • Quantification of CTCs and assessment of various biomarkers ; change from baseline.
    ORR, PFS,CBR, DOR, incidenza e la severità del trattamento di eventi avversi (TEAEs),
    anomalie di laboratorio, i sintomi mirate (tra cui diarrea e
    neuropatia); incidenza di riduzioni della dose, intensità di dose
    • scala QLQ-C30 individuali, il punteggio complessivo e il valore BR23 punteggio e
    cambiano nel tempo della partecipazione allo studio
    • I parametri farmacocinetici derivati‚Äč‚Äč, comprese le Cmax, AUC, il tempo di Cmax (Tmax), V,
    t ½ di eliminazione e di CL, con un'analisi esplorativa in relazione ad eventuali
    correlazione con le caratteristiche di base diverse (ad esempio, età e UGT1A1
    status)
    • misure selezionati di utilizzo sanitario
    • Quantificazione delle CTC e la valutazione di biomarcatori diversi , cambiamenti dalla visita basale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 8 weeks (+/- 7 days)
    ogni 8 sett, finestra di 7 giorni
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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.1.2.1Number of subjects for this age range: 672
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 840
    F.4.2.2In the whole clinical trial 840
    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)
    na
    na
    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 Decision2012-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-08
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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