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    Summary
    EudraCT Number:2010-024133-23
    Sponsor's Protocol Code Number:NO25530
    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:2012-03-20
    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 number2010-024133-23
    A.3Full title of the trial
    An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine
    Studio multicentrico di fase II, in aperto, sul BRAF inibitore RO5185426 in pazienti affetti da carcinoma papillare della tiroide (CPT) metastatico o non resecabile, positivo alla mutazione del BRAF V600 e resistente allo iodio radioattivo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation
    Uno studio con RO5185426 nei pazienti con carcinoma papillare della tiroide metastatico o non resecabile, positivo per la mitazione V600 di BRAF
    A.4.1Sponsor's protocol code numberNO25530
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01286753
    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 SponsorF. Hoffman-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffman-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzachestrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 namevemurafenib
    D.3.2Product code RO5185426/BS1111010
    D.3.4Pharmaceutical form Film-coated 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 INNVemurafenib
    D.3.9.1CAS number 918504-65-1
    D.3.9.2Current sponsor codeRO5185426
    D.3.9.3Other descriptive nameRG7204, PLX4032
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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
    Metastatic or unresectable papillary thyroid cancer positive for BRAF V600 mutation and resistant to radioactive iodine therapy
    Cancro papillare della tiroide metastatico o non resecabile positivo al BRAF V600 e resistente alla terapia allo iodio radioattivo
    E.1.1.1Medical condition in easily understood language
    Neoplasms
    Neoplasie
    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 LLT
    E.1.2Classification code 10033701
    E.1.2Term Papillary thyroid cancer
    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 evaluate best overall response rate (BORR) (complete + partial response) in Cohort 1 (TKI-naïve patients). − BORR will be based on investigator assessment, based on the findings on computed tomography (CT) or magnetic resonance imaging, using RECIST 1.1
    Valutare il miglior tasso di risposta complessiva (BORR) (risposta completa + parziale) nella coorte 1 (pazienti naïve alla tirosin Kinasi-TKI). – Il BORR si basera' sulla valutazione dello sperimentatore, in base alle informazioni relative agli esami di tomografia computerizzata (TC) o di risonanza magnetica per immagini, usando RECIST 1.1
    E.2.2Secondary objectives of the trial
    1. To evaluate clinical benefit rate (CBR) in TKI naïve patients 2. To further assess efficacy of Vemurafenib using the following secondary variables: duration of response, progression free survival (PFS), and overall survival (OS) in TKI-naïve patients 3. To evaluate the efficacy (BORR, CB, duration of response, PFS, and OS) in TKI-exposed patients 4. To evaluate the tolerability and safety profile of Vemurafenib using the NCI CTCAE (version 4.0) in both TKI-naïve and TKI treated patients 5. To characterize the pharmacokinetic (PK) profile of Vemurafenib in patients with thyroid cancer
    1. Valutare il grado di beneficio clinico (CBR) nei pazienti naïve a TKI 2. Valutare ulteriormente l’efficacia di Vemurafenib usando le seguenti variabili secondarie: durata della risposta, sopravvivenza libera da progressione (PFS), e sopravvivenza complessiva (OS) in pazienti naïve a TKI 3. Valutare l’efficacia (BORR, CB, durata della risposta, PFS, e OS) in pazienti esposti a TKI 4. Valutare il profilo di tollerabilita' e di sicurezza di Vemurafenib usando NCI CTCAE (versione 4.0) sia in pazienti naïve a TKI che in quelli trattati con TKI 5. Caratterizzare il profilo farmacocinetico (PK) di vemurafenib in pazienti con carcinoma della tiroide
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients >/= 18 years of age - Metastatic or unresectable papillary thyroid cancer for which standard curative or palliative measures do not exist or are no longer effective - Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test) - Radioactive Iodine resistant disease - Prior therapy excluding (Cohort 1) or including (Cohort 2) tyrosine kinase inhibitor with activity against VEGFR2 - Clinically relevant disease progression according to RECIST criteria within the prior 14 months - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Adequate hematological, renal and liver function
    - Pazienti adulti &gt;/= 18 anni di eta' - Cancro papillare tiroideo metastatico o non asportabile chirurgicamente per cui non esistono o non sono piu' efficaci i trattamenti standard di cura o palliativi NOTA: potranno essere arruolati quei pazienti i cui carcinomi mostrano aree di “altra istologia”, a condizione che l’istologia del carcinoma rimanga prevalentemente di tipo papillare. Si potra' discutere con il Medical Monitor se vi sono domande riguardanti l’ammissibilita' di pazienti, i cui carcinomi presentino un’istologia “mista”.- Positivita' per la mutazione BRAF V600 (Roche Cobas 4800 BRAF V600 Mutation Test) - Patologia resistente allo iodio radioattivo - Terapia precedente che escluda (Coorte 1) o includa (Coorte 2) sorafenib e trattamento con inibitore della tirosin-chinasi - Progressione della patologia clinicamente rilevante in accordo ai criteri RECIST entro i 14 mesi precedenti - Stato di performance Eastern Cooperative Oncology Group (ECOG) di 0 o 1 - Adeguate funzionalita' ematologiche, renali ed epatiche
    E.4Principal exclusion criteria
    - Histological diagnosis other than papillary thyroid carcinoma (PTC), including squamous cell variants of PTC or PTC with areas of squamous metaplasia - Active or untreated CNS metastases or previous whole brain irradiation - History of or known carcinomatous meningitis - Anticipated or ongoing administration of any anti-cancer therapies other than those administered in the study - Active squamous cell skin cancer that has not been excised or adequately healed post excision - Previous treatment with any agent tat specifically and selectively targets the MEK or BRAF pathway - Prior radiotherapy to the only measurable lesion - Clinically relevant cardio-vascular disease or event within the prior 6 months
    - Diagnosi istologica diversa da carcinoma papillare tiroideo (PTC), incluse le varianti del PTC a cellule squamose o PTC con aree di metaplasie squamose - Metastasi al CNS attive o non trattate - Storia o conoscenza di meningite carcinomatosa - Somministrazione in corso o anticiapta di qualsiasi terapia anti-cancro diverse da quelle somministrate nello studio - Cancro della pelle a cellule squamose attivo, non rimosso chirurgicamente o guarito in modo adeguato dopo la rimozione - Trattamenti precedenti con un qualsiasi agente che mira selettivamente e specificatamente il pathway di MEK o BRAF - Radioterapia precedente sull`unica lesione misurabile - Patologie cardio-vascolari clinicamente rilevanti o eventi entro i sei mesi precedenti
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response rate (BORR) in TKI-naive patients (Cohort 1), assessed by the investigator according to RECIST criteria
    Tasso di migliore risposta globale (BORR) nei pazienti naive a TKI (Coorte 1), valutato dallo sperimentatore in accordo con i criteri RECIST
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    18 mesi
    E.5.2Secondary end point(s)
    1. Clinical benefit rate (objective response rate + stable disease) in TKI-naive patients 2. Duration of response in TKI-naive patients 3. Progression-free survival in TKI-naive patients 4. Overall survival in TKI-naive patients 5. Best overall response rate in TKI-exposed patients (Cohort 2) 6. Clinical benefit rate in TKI-exposed patients 7. Duration of response in TKI-exposed patients 8. Progression-free survival in TKI-exposed patients 9. Overall survival in TKI-exposed patients 10. Safety: Incidence of adverse events 11. Pharmacokinetics (Tmax, Cmax, Cmin, AUC)
    1. Tasso di beneficio clinico (tasso di risposta obiettivo + malattia stabile) nei pazienti naive per TKI 2. Durata della risposta nei pazienti naive per TKI 3. Sopravvivenza libera da malattia nei pazienti naive per TKI 4. Sopravvivenza globale nei pazienti naive per TKI 5. Miglior tasso di risposta nei pazienti esposti a TKI (Coorte 2) 6. Tasso di benefico clinico nei pazienti esposti a TKI 7. Durata della risposta nei pazienti esposti a TKI 8. Sopravvivenza libera da malattia nei pazienti esposti a TKI 9. Sopravvivenza globale nei pazienti esposti a TKI 10. Sicurezza: incidenza degli eventi avversi 11. Farmacocinetica (Tmax, Cmax, Cmin, AUC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time Frame: 18 months 2. Time Frame: 4.5 years 3. Time Frame: 4.5 years 4. Time Frame: 4.5 years 5. Time Frame: 18 months 6. Time Frame: 18 months 7. Time Frame: 4.5 years 8. Time Frame: 4.5 years 9. Time Frame: 4.5 years 10. Time Frame: 4.5 years 11. Time Frame: 4.5 years
    1. Finestra temporale: 18 mesi 2. Finestra temporale: 4.5 anni 3. Finestra temporale: 4.5 anni 4. Finestra temporale: 4.5 anni 5. Finestra temporale: 18 mesi 6. Finestra temporale: 18 mesi 7. Finestra temporale: 4.5 anni 8. Finestra temporale: 4.5 anni 9. Finestra temporale: 4.5 anni 10. Finestra temporale: 4.5 anni 11. Finestra temporale: 4.5 anni
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Samples for BRAF V600 testing, exploratory biomarkers, Roche Clinical Repository, tolerability
    Test di campioni di BRAF V600, biomarcatori esplorativi, Roche Clinical Repository, tollerabilita'
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    United States
    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
    The study will end when all patients have completed at least 6 months of follow up after discontinuation of study drug.
    Lo studio terminera' quando tutti i pazienti avranno completato almeno 6 mesi di followup dopo l'interruzione del farmaco sperimentale.
    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 months37
    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 months37
    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: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 40
    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)
    -
    -
    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 Decision2008-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-29
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