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    Summary
    EudraCT Number:2010-022746-24
    Sponsor's Protocol Code Number:TS-P04834
    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:2012-08-02
    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 number2010-022746-24
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled Study
    of the Safety and Efficacy of Rolapitant for the Prevention of
    Chemotherapy-
    Induced Nausea and Vomiting (CINV) in Subjects Receiving Moderately
    Emetogenic Chemotherapy (MEC)
    Studio multicentrico di fase 3, in doppio cieco, randomizzato con controllo attivo per valutare l'efficacia e la sicurezza di Rolapitant nella prevenzione della nausea e del vomito indotti (CINV) in soggetti che ricevono chemioterapia moderatamente emetogenica (MEC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study of Rolapitant versus Placebo for the prevention of nausea
    and vomiting related to chemotherapy that has a moderate likelihood of
    inducing nausea and vomiting
    Studio di ricerca di Rolapitant verso placebo per la prevenzione della nausea e del vomito indotti da chemioterapia che ha moderata capacita' di indurre nausea e vomito
    A.4.1Sponsor's protocol code numberTS-P04834
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01500226
    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 SponsorTESARO, INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTesaro
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharm-Olam International (UK) Ltd Belgrade
    B.5.2Functional name of contact pointProject Manger
    B.5.3 Address:
    B.5.3.1Street AddressOmladinskih Brigada 88b
    B.5.3.2Town/ cityBelgrade
    B.5.3.3Post code11000
    B.5.4Telephone number381 11 3538 715
    B.5.5Fax number+381 11 3538750
    B.5.6E-mailJovana.vujanovic@pharm-olam.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 nameROLAPITANT
    D.3.2Product code SCH 619734
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 914462-92-3
    D.3.9.2Current sponsor codeSCH619734 hydrochloride monohydrate
    D.3.9.3Other descriptive nameROLAPITANT
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Moderately Emetogenic Chemotherapy (MEC)
    nausea e vomito indotti da chemioterapia in soggetti che ricevono chemioterapia moderatamente emetogenica (MEC)
    E.1.1.1Medical condition in easily understood language
    Nausea and Vomiting in Subjects Receiving Moderately Emetogenic Chemotherapy
    nausea vomito indotti da chemioterapia in soggetti che ricevono chemioterapia moderatamente emetogenica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10042613
    E.1.2Term Surgical and medical procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10054133
    E.1.2Term Prophylaxis of nausea and vomiting
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049091
    E.1.2Term Chemotherapy antiemetic prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving MEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (>24 to 120 hours).
    • Determinare se la somministrazione di rolapitant con granisetron e desametasone migliora la CINV nella fase tardiva (da &gt;24 a 120 ore) della CINV rispetto alla somministrazione del placebo con granisetrone e desametasone nei soggetti che ricevono MEC. L’obiettivo primario sarà basato sulla risposta completa (definita come nessun episodio emetico e nessun utilizzo di farmaci di emergenza) nella fase tardiva (da &gt;24 a 120 ore).
    E.2.2Secondary objectives of the trial
    -To determine the effect of rolapitant on the incidence of complete response in the acute (0-24 hours) and overall (0-120 hours) phases of CINV. - To determine if rolapitant is safe and well tolerated in subjects receiving MEC. -To determine the effect of rolapitant treatment on the incidences of no emesis in the acute, delayed and overall phases of CINV. - To determine the effect of rolapitant treatment on the incidence of no significant nausea in the overall phase of CINV. - To determine the effect of rolapitant treatment on the time to first emesis or use of rescue medication.
    - Determinare l'effetto di Rolapitant sul tasso di risposta completa nella fase acuta (da 0 a 24 ore) ed in quella complessiva (da 0 a 120 ore) della CINV.- Determinare se il rolapitant è sicuro e ben tollerato in soggetti che ricevono MEC.- Determinare l’effetto del trattamento con rolapitant sulle incidenze di assenza di emesi nelle fasi acuta,tardiva e complessiva della CINV.- Determinare l’effetto del trattamento con rolapitant sull’incidenza di assenza di nausea significativa nella fase complessiva della CINV.- Determinare l’effetto del trattamento con rolapitant sul tempo trascorso fino alla comparsa del primo episodio emetico o al primo utilizzo di farmaci di emergenza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is 18 years of age or older, of either gender, and of any race. 2. Subject is naïve to moderately or highly emetogenic chemotherapy, and is to receive a first course of MEC including one or more of the following agents: cyclophosphamide IV (<1500 mg/m2), doxorubicin, epirubicin, carboplatin, idarubicin, ifosfamide, irinotecan, daunorubicin, cytarabine IV (>1 g/m2). The length of each chemotherapy cycle should be no less than 2 weeks. 3. Subject has a Karnofsky performance score of ≥60. 4. Subject has a predicted life expectancy of ≥ 4 months. 5. Subject has adequate bone marrow, kidney, and liver function as evidenced by: a. Absolute neutrophil count ≥1500/mm3. b. Platelet count ≥100,000/mm3. c. Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal range (ULN). For subjects with known liver metastases ≤5 x ULN. d. Alanine aminotransferase (ALT) ≤2.5 x ULN. For subjects with known liver metastases ≤5 x ULN. e. Bilirubin ≤1.5 x ULN, except for subjects with Gilbert's syndrome. f. Creatinine ≤1.5 x ULN. If a single or multiple screening laboratory test value exceeds, but is close to, the limit(s) of the reference range(s) as defined in the protocol inclusion criteria, subjects will be allowed to repeat these out-of-range tests once. If the repeated test results meet the study requirement, these subjects can be enrolled. 6. Female subjects of childbearing potential must agree to use a medically accepted method of birth control prior to Visit 1 and to continue its use during the study and for at least 30 days after the study. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, hormonal contraception, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), and surgical sterilization (e.g., vasectomy, hysterectomy or tubal ligation). Female subjects who are postmenopausal (i.e., have amenorrhea for 12 months) or surgically sterile are exempted from the use of contraception during the study. 7. Subject is able to read, understand, and complete all study-related documents. 8. Subject provides written informed consent.
    Saranno selezionati per questo studio soggetti adulti che ricevono MEC. Il soggetto ha almeno 18 anni di età, maschio o femmina, di qualsiasi razza. 2. Il soggetto è naïve al trattamento con chemioterapia moderatamente o altamente emetogenica, e riceverà un primo corso di MEC inclusi uno o più dei seguenti agenti: ciclofosfamide IV (&lt;1500 mg/m2), doxorubicina, epirubicina, carboplatino, idarubicina, ifosfamide, irinotecan, daunorubicina, citarabina IV (&gt;1 g/m2). La durata di ciascun ciclo di chemioterapia non deve essere inferiore a 2 settimane. 3. Il soggetto ha un indice di performance secondo Karnofsky di 60. 4. Il soggetto ha un’aspettativa di vita prevista di 4 mesi. 5. Il soggetto ha adeguata funzionalità midollare, renale ed epatica comprovata da: a. Conta assoluta dei neutrofili 1500/mm3. b. Conta delle piastrine 100.000/mm3. c. Aspartato aminotransferasi (AST) 2,5 x il limite superiore dell’intervallo normale (ULN). Per soggetti con metastasi epatiche conclamate 5 x ULN. d. Alanina aminotransferasi (ALT) 2,5 x ULN. Per soggetti con metastasi epatiche conclamate 5 x ULN. e. Bilirubina 1,5 x ULN, tranne per soggetti con sindrome di Gilbert. f. Creatinina 1,5 x ULN. Se un singolo valore o più valori di test di laboratorio eccedono di poco i limiti dei valori di riferimento come definito nei criteri di inclusione del protocollo, ai soggetti sarà consentito ripetere una volta questi test. Se i risultati del test ripetuto soddisfano i requisiti dello studio, questi soggetti possono essere arruolati. 6. I soggetti di sesso femminile e potenzialmente fertili devono acconsentire a utilizzare un metodo contraccettivo accettabile a livello medico prima della Visita 1 e a continuare ad utilizzarlo durante lo studio e per almeno 30 giorni dopo lo studio. Metodi contraccettivi accettabili includono preservativi (per uomini e per donne) con o senza agente spermicida, contraccettivi ormonali, diaframma o cappuccio cervicale con lo spermicida, un dispositivo intrauterino (IUD) su prescrizione medica, e la sterilizzazione chirurgica (ad es. vasectomia, isterectomia, o legatura delle tube). I soggetti femminili che sono in postmenopausa (ossia, sono in amenorrea da 12 mesi) o chirurgicamente sterili sono esentati dall’utilizzo di contraccettivi durante lo studio. 7. Il soggetto è in grado di leggere, comprendere, e completare tutti i documenti relativi allo studio. 8. I soggetti devono fornire il consenso informato scritto.
    E.4Principal exclusion criteria
    1. Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject. 2. Subject has a contraindication to the administration of prescribed MEC agent, granisetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, or systemic infection. 3. Subject is a woman of childbearing potential with a positive urine or serum pregnancy test within 3 days prior to study drug administration or is breast-feeding. 4. Subject has taken the following agents within the last 48 hours prior to the start of treatment with study drug: a. 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.). Palonosetron is not permitted within 7 days prior to administration of investigational product. b. Phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.) c. Benzamides (metoclopramide, alizapride, etc.) d. Domperidone e. Cannabinoids XML File Identifier: 0uX31lSHH39aExiPo+cRH69mbYc= Page 12/22 f. NK1 antagonist (aprepitant) g. Benzodiazepines (lorazepam, alprazolam, etc) 5. Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6, except on Day 1. (There is no restriction for Day 1.) 6. Subject is scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6. 7. Subject has received systemic corticosteroids or sedative antihistamines (dimenhydrinate, diphenhydramine, etc.) within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes). Subjects who are receiving inhaled steroids for respiratory conditions or topical steroids for skin disorders can be enrolled. 8. Subject has symptomatic primary or metastatic CNS disease. 9. Subject has ongoing vomiting, retching, or clinically severe nausea caused by any etiology or has a history of anticipatory nausea and vomiting. 10. Subject has vomited and/or has had dry heaves/retching within 24 hours prior to the start of MEC on Day 1 in Cycle 1. 11. Subject who has used any investigational drugs within 30 days of randomization. 12. Subject who is participating in any other clinical study.
    Qualsiasi trattamento attuale, anamnesi, o condizione non controllata diversa da un tumore maligno (ossia, alcoolismo o segni di abuso di alcool, epilessia, condizioni mediche o psichiatriche) che, a parere dello sperimentatore, confonderebbe i risultati dello studio o porrebbe rischi ingiustificati nel somministrare il farmaco in studio al soggetto. 2. Il soggetto ha controindicazioni alla somministrazione dell’agente prescritto per la MEC, granisetrone, o desametasone, inclusa, senza limitazioni, un’anamnesi di ipersensibilità ai farmaci o ai loro componenti, grave insufficienza renale, grave soppressione del midollo osseo, o infezione sistemica. 3. Il soggetto è una donna in età fertile con risultati positivi al test di gravidanza su siero o urine entro i 3 giorni precedenti alla somministrazione del farmaco in studio o è in allattamento. 4. Il soggetto ha preso i seguenti agenti entro le ultime 48 ore prima dell’avvio del trattamento con il farmaco in studio: a. Gli antagonisti 5-HT3 (ondansetron, granisetron, dolasetron, tropiseron, ecc.). Il palonosetron non è permesso entro 7 giorni prima della somministrazione del prodotto sperimentale. b. Fenotiazine (proclorperazina, flufenazina, perfenazina, tietilperazina, clorpromazina, ecc.) c. Benzamidi (metoclopramide, alizapride, ecc.) d. Domperidone e. Cannabinoidi f. Antagonista NK1 (aprepitant) g. Benzodiazepine (lorazepam, alprazolam, ecc.) 5. Il soggetto è in procinto di ricevere altri agenti chemioterapici con un livello di emetogenicità di 3 o superiore (Scala di Hesketh) dal Giorno -2 al Giorno 6, a eccezione del Giorno 1. (Non ci sono restrizioni per il Giorno 1.) 6. Il soggetto è in procinto di ricevere radioterapia all’addome o al bacino dal Giorno -5 al Giorno 6. 7. Il soggetto ha ricevuto corticosteroidi sistemici o antistaminici sedativi (dimenidrinato, difenidramina, ecc.) entro 72 ore dal Giorno 1 dello studio, tranne come premedicazione per la chemioterapia (ad es. taxani). I soggetti che ricevono steroidi per via inalatoria per condizioni respiratorie o steroidi topici per disturbi cutanei possono essere arruolati. 8. Il soggetto ha una malattia del sistema nervoso centrale primaria o metastatica. 9. Il soggetto ha vomito continuo, conati di vomito, nausea clinicamente grave causata da qualsiasi eziologia, o ha un’anamnesi di nausea e vomito anticipatori. 10. Il soggetto ha vomitato e/o ha avuto conati di vomito entro 24 ore prima dell’avvio della MEC il Giorno 1 del Ciclo 1. 11. Il soggetto ha usato farmaci sperimentali entro 30 giorni dalla randomizzazione. 12. Il soggetto sta partecipando ad altri studi clinici.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study is the complete response rate in the delayed phase of CINV, from >24 through 120 hours following initiation of moderately emetogenic chemotherapy.
    L’endpoint primario di efficacia per questo studio è il tasso di risposta completa nella fase tardiva della CINV (da >24 a 120 ore successive all’avvio della chemioterapia moderatamente emetogenica). La risposta completa è definita come nessun episodio emetico e nessun utilizzo di farmaci di emergenza.
    E.5.1.1Timepoint(s) of evaluation of this end point
    >24 through 120 hours following initiation of moderately emetogenic chemotherapy. For Cycle 1, telephone contact will be made with each subject every morning on Days 2 to 5 at approximately the same time each day to assess the subject's status and to ensure that the subject is appropriately recording any nausea and vomiting episodes, use of rescue medication, and daily nausea ratings in the NV Subject Diary.
    >24 fino a 120 ore dopo l'inizio della chemioterapia moderatamente emetogenica. Per il ciclo 1 contatto telefonico ogni mattina a i giorni 2 e 5 piu' o meno alla stessa ora per valutare lo stato clinico del pz e assicurare che il pz stia registrando correttamente ogni episodio di nausea e vomito, l'utilizzo di farmaci di emergenza e giornalmente gli score di nausea nel diario paziente NV.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints for this study include: •The incidence of complete response during the acute (0-24 hours) and overall (0 120 hours) phases of CINV following the initiation of MEC. -No emesis (no vomiting, retching, or dry heaves; includes subjects who received rescue medication) in the acute, delayed and overall phases of CINV. - No significant nausea (maximum VAS <25 mm) in the overall phase of CINV. - Time to first emesis or to use of rescue medication. The tertiary efficacy endpoints for this study include: - No significant nausea in the acute and delayed phases of CINV. - No nausea (maximum VAS <5 mm) and Complete protection (no emesis, no rescue medication, and maximum nausea VAS <25 mm on a 0- to 100 mm scale) in the acute, delayed and overall phases of CINV. - No impact on daily life (total score >108) as assessed by the FLIE Questionnaire
    Gli endpoint chiave secondari sono i tassi di risposta completa per la fase acuta (da 0 a 24 ore) e quella complessiva (da 0 a 120 ore) della CINV.Saranno valutati i seguenti endpoint di efficacia secondari: •Nessuna emesi (nessun vomito o conato di vomito; include i soggetti che hanno ricevuto farmaci di emergenza) durante la fase acuta, tardiva e complessiva della CINV •Nessuna nausea significativa (massimo VAS <25 mm) durante la fase complessiva della CINV •Tempo trascorso fino alla comparsa del primo episodio emetico o al primo utilizzo di farmaci di emergenza.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall: - 0 to 120 hours following initiation of MEC. - Acute: 0 to 24 hours following initiation of MEC. - Delayed: >24 to 120 hours following initiation of MEC. For Cycle 1, telephone contact every morning on Days 2 to 5 to assess the subject's status and to ensure that the subject is appropriately recording any nausea and vomiting episodes, use of rescue medication, and daily nausea ratings in the NV Subject Diary. Assessment in Subsequent Cycles (up to Five Additional Cycles for up to Six Cycles Total) Assessment questions on Days 6, 7, or 8 in each subsequent cycle (Cycles 2 to 6)
    Globale: 0-120 hrs dopo inizio MEC Acuta:0-24 hr dopo inizio MEC Teardiva:>24 hr a 120 hr dopo inizio MEC Per il ciclo 1 contatto telefonico ogni mattina giorni 2 e 5 per valutare lo stato clinico del pz e assicurare che il pz stia registrando correttamente ogni episodio di nausea e vomito, l'utilizzo di farmaci di emergenza e giornalmente gli score di nausea nel diario paziente NV.Le valutazioni nei cicli successivi( fino a 5 cicli successivi per un totale di 6 cicli).Domande valutative al giorno 6,7 o8 in ogni ciclo successivo (ciclo 2 fino a 6)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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 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 EEA44
    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
    Belarus
    Brazil
    Chile
    Ecuador
    Georgia
    Hong Kong
    Korea, Republic of
    Mexico
    Peru
    Puerto Rico
    Russian Federation
    South Africa
    Taiwan
    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 overall study ends when the last remaining subject has completed or has been discontinued from the study. The last protocol-specified contact (visits or telephone contacts) at Cycle 6, or at final chemotherapy cycle in which the patient elects to participate. For those subjects who do not complete the study or who are lost to follow up, subject participation will be considered terminated upon the completion of the last visits or phone contact.
    il termine dello studio avverra' quando l'ultimo pz in studio ha completato o si e' ritirato dallo studio. L'ultimo contatto specificato dal protocollo (visita o contatto telefonico) e' al ciclo 6 o alla fine dell'ultimo ciclo di chemioterapia previ
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    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: 1080
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 348
    F.4.2.2In the whole clinical trial 1350
    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)
    standard medical care
    assistenza standard di pratica clinica
    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 Decision2012-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
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