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    Summary
    EudraCT Number:2012-001730-33
    Sponsor's Protocol Code Number:AV-951-12-205
    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:2012-10-11
    Trial 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 number2012-001730-33
    A.3Full title of the trial
    A PHASE 2 RANDOMIZED, DOUBLE-BLIND, CROSSOVER, CONTROLLED, MULTI-CENTER, SUBJECT PREFERENCE STUDY OF TIVOZANIB HYDROCHLORIDE VERSUS SUNITINIB IN THE TREATMENT OF SUBJECTS WITH METASTATIC RENAL CELL CARCINOMA
    Studio di fase 2, randomizzato, in doppio cieco, in crossover, controllato, multicentrico per confrontare la preferenza dei soggetti tra tivozanib cloridrato e sunitinib nel trattamento del carcinoma a cellule renali metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE 2 RANDOMIZED, DOUBLE-BLIND, CROSSOVER, CONTROLLED, MULTI-CENTER, SUBJECT PREFERENCE STUDY OF TIVOZANIB HYDROCHLORIDE VERSUS SUNITINIB IN THE TREATMENT OF SUBJECTS WITH METASTATIC RENAL CELL CARCINOMA
    Studio di fase 2, randomizzato, in doppio cieco, in crossover, controllato, multicentrico per confrontare la preferenza dei soggetti tra tivozanib cloridrato e sunitinib nel trattamento del carcinoma a cellule renali metastatico
    A.4.1Sponsor's protocol code numberAV-951-12-205
    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 SponsorAVEO PHARMACEUTICALS, 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 supportAveo Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAveo Pharmaceuticals Inc
    B.5.2Functional name of contact pointKristina Johnson
    B.5.3 Address:
    B.5.3.1Street Address75 Sidney Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number001-617--299-5727
    B.5.5Fax number001-617-995-4827
    B.5.6E-mailkjohnson@aveooncology.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/747
    D.3 Description of the IMP
    D.3.1Product nametivozanib hydrochloride
    D.3.2Product code AV-951
    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.3.8INN - Proposed INNtivozanib hydrochloride
    D.3.9.1CAS number 682745-41-1
    D.3.9.2Current sponsor codeAV-951
    D.3.9.3Other descriptive nameKRN951
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 1.5
    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 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 namesutinib
    D.3.2Product code L01XE04
    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.3.8INN - Proposed INNSUNITINIB
    D.3.9.1CAS number 557795-19-4
    D.3.9.3Other descriptive namesutent
    D.3.9.4EV Substance CodeSUB22321
    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
    metastatic renal cell carcinoma
    carcinoma a cellule renali metastatico
    E.1.1.1Medical condition in easily understood language
    metastatic renal cell carcinoma
    carcinoma a cellule renali metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10038400
    E.1.2Term Renal carcinoma stage IV
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10038399
    E.1.2Term Renal carcinoma stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10050076
    E.1.2Term Metastatic renal carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare subject treatment preference of tivozanib versus sunitinib
    • Confrontare la preferenza soggettiva di trattamento tra tivozanib cloridrato e sunitinib.
    E.2.2Secondary objectives of the trial
    To compare overall safety and tolerability in subjects treated with tivozanib and sunitinib. To assess the frequency of dose modifications in subjects treated with tivozanib and sunitinib. To evaluate the Quality of Life (QoL) (including kidney-specific symptoms and fatigue) in subjects treated with tivozanib and sunitinib
    • Confrontare la sicurezza e la tollerabilità complessive nei soggetti trattati con tivozanib cloridrato e sunitinib.
    • Valutare la frequenza delle modifiche della dose in soggetti trattati con tivozanib cloridrato e sunitinib.
    • Valutare la qualità della vita (Quality of Life, QoL) (compresi i sintomi specifici per i reni e l’affaticamento) in soggetti trattati con tivozanib cloridrato e sunitinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥ 18 year old males or females 2. Subjects with unresectable mRCC 3. Histologically or cytologically confirmed RCC of any histology 4. Subjects with or without prior nephrectomy 5. Evaluable disease per RECIST Version 1.1 (see Appendix A). 6. ECOG performance status of 0 or 1 (see Appendix B) 7. A female is eligible to participate if she is of non-childbearing potential or has documentation of a negative pregnancy test prior to the start of the study treatment. Sexually active pre-menopausal female subjects (and male subjects whose sexual partners are of childbearing potential) must agree to use adequate, highly effective contraceptive measures, while on study and for 45 days after the last dose of last study drug. Effective birth control includes (a) intrauterine device (IUD) plus one barrier method; (b) oral, implantable or injectable contraceptives plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). 8. Ability to give written informed consent and comply with protocol requirements, including drug treatments and follow-up procedures
    1. Maschi o femmine di ≥ 18 anni di età
    2. Soggetti con RCC metastatico non resecabile chirurgicamente
    3. RCC confermato istologicamente o citologicamente di qualsiasi istologia
    4. Soggetti con o senza nefrectomia precedente devono essere stati sottoposti a precedente nefrectomia (completa o parziale) per l’escissione del tumore primario
    5. Malattia valutabile in base a RECIST Versione 1.1
    6. Stato prestazionale ECOG di 0 o 1
    7. Un soggetto di sesso femminile è idoneo a partecipare se non è fertile o se è in possesso di documentazione di test di gravidanza negativo prima dell’inizio del trattamento dello studio. Soggetti di sesso femminile sessualmente attivi prima della menopausa (e soggetti di sesso maschile le cui partner sono fertili) devono acconsentire ad adottare misure contraccettive adeguate e altamente efficaci durante lo studio e per 45 giorni dopo l’ultima dose dell’ultimo farmaco dello studio. Il controllo efficace delle nascite comprende: (a) dispositivo intrauterino (IUD) più un metodo di barriera; (b) contraccettivo orale, impiantabile o iniettabile più un metodo di barriera; o (c) 2 metodi di barriera. Per metodi di barriera efficaci si intendono preservativi maschili o femminili, diaframmi e spermicidi (creme o gel contenenti una sostanza chimica che uccide gli spermatozoi).
    8. Capacità di fornire il consenso informato scritto e attenersi ai requisiti previsti dal protocollo, inclusi i trattamenti farmacologici e le procedure di follow-up.
    E.4Principal exclusion criteria
    1. Any prior systemic therapy for treatment of mRCC 2.Central nervous system metastases. 3.Any of the following hematologic and coagulation abnormalities: Hemoglobin < 9.0 g/dL; oAbsolut e neutrophil count (ANC) < 1500 per mm3; Platelet count < 100,000 per mm3. 4.Any of the following serum chemistry and urinalysis abnormalities: oTotal bilirubin > 1.5 × ULN (or > 2.5 x ULN for subjects with asymptomatic Gilbert’s syndrome) oAspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × ULN (or > 5 × ULN for subjects with liver metastasis); oAlkaline phosphatase > 2.5 × ULN (or > 5 × ULN for subjects with liver or bone metastasis); oCreatinine > 2.0 × ULN; oProteinuria > 3+ by urinalysis or urine dipstick. 5.Significant cardiovascular disease, 6.Non-healing wound, bone fracture, or skin ulcer. 7.Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug. 8.Serious/active infection or infection requiring parenteral antibiotics. 9.Corrected QT interval (QTc) of >480 msec using Bazett’s formula. 10.Radiotherapy or minor surgical procedure within 2 weeks, or major surgical procedure within 4 weeks prior to administration of first dose of study drug; inadequate recovery from prior surgical procedure. 11.Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug. 12 Significant bleeding disorders within 6 months prior to administration of first dose of study drug 13.Currently active second primary malignancy, including hematologic malignancies (leukemia, lymphoma, multiple myeloma, etc.), other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Subjects are considered to have a currently active malignancy if they have completed anti-cancer therapy and have not been disease free for > 2 years. 14.Pregnant or lactating females. 15.History of genetic or acquired immune suppression disease such as human immunodeficiency virus (HIV); subjects on immune suppressive therapy for organ transplant. 16.Life-threatening illness or organ system dysfunction compromising safety evaluation. 17.Requirement for hemodialysis or peritoneal dialysis. 18.Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of study drugs, major resection of the stomach or small bowel, or gastric bypass procedure. 19.Known hypersensitivity to drugs chemically related to tivozanib hydrochloride or sunitinib or their excipients. 20.Psychiatric disorder or altered mental status precluding informed consent or protocol related testing
    1-Qualsiasi terapia sistemica precedente per il trattamento dell’RCC metastatico.
    2-Metastasi al sistema nervoso centrale
    3-Qualunque delle seguenti anomalie ematologiche e della coagulazione: Emoglobina &lt; 9,0 g/dl; Conta assoluta dei neutrofili (ANC) &lt; 1500/mm3; Conta piastrinica &lt; 100.000/mm3.
    4 Qualsiasi delle seguenti anomalie della chimica del siero e analisi delle urine:
    Aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) &gt; 2,5 × ULN (o &gt; 5 × ULN in soggetti con metastasi epatica); Fosfatasi alcalina &gt; 2,5 × ULN (o &gt; 5 × ULN per soggetti con metastasi epatica od ossea); Creatinina &gt; 2,0 × ULN; Proteinuria &gt; 3+ in base agli esami delle urine o stick urinario.
    5- Malattia cardiovascolare significativa
    6-Ferita che non si rimargina, frattura ossea o ulcera cutanea.
    7-Malattia ulcerosa peptica attiva, malattia infiammatoria intestinale, colite ulcerosa o altra patologia gastrointestinale con aumento del rischio di perforazione; anamnesi di fistola addominale, perforazione gastrointestinale o ascesso intraddominale nelle 4 settimane precedenti la somministrazione della prima dose di farmaco dello studio.
    8-Infezione grave/attiva o infezione che necessita di antibiotici parenterali.
    9-Intervallo QT corretto (QTc) &gt; 480 msec con la formula di Bazett.
    10-Radioterapia o intervento chirurgico di lieve entità entro 2 settimane o intervento chirurgico di rilievo nelle 4 settimane prima della somministrazione della prima dose di farmaco dello studio; ripresa inadeguata dall’intervento chirurgico precedente.
    11-Disturbi tromboembolici o vascolari significativi nei 6 mesi precedenti la somministrazione della prima dose di farmaco dello studio,
    12-Disturbi della coagulazione del sangue significativi nei 6 mesi precedenti la somministrazione della prima dose di farmaco dello studio
    13-Secondi tumori primari attualmente attivi, incluse malignità ematologiche (leucemia, linfoma, mieloma multiplo, ecc.), diversi dal carcinoma della pelle non-melanoma, carcinoma prostatico non metastatico, carcinoma cervicale in situ e carcinoma mammario duttale o lobulare. I soggetti sono considerati come aventi un tumore attualmente attivo se hanno completato la terapia anticancro e non sono liberi da malattia da &gt; 2 anni.
    14-Donne incinte o in allattamento.
    15-Anamnesi di malattia immunodepressiva genetica o acquisita, quale il virus dell’immunodeficienza umana (HIV); soggetti in terapia immunosoppressiva per il trapianto d’organi.
    16-Patologia potenzialmente letale o disfunzione organica che compromette le valutazioni di sicurezza.
    17-Necessità di emodialisi o dialisi peritoneale.
    18-Incapacità di ingoiare capsule, sindrome da malassorbimento o malattia gastrointestinale che compromette fortemente l’assorbimento dei farmaci dello studio, resezione importante dello stomaco o dell’intestino tenue o intervento di bypass gastrico.
    19-Ipersensibilità nota ai farmaci chimicamente correlati a tivozanib cloridrato o sunitinib o ai loro eccipienti.
    20-Disturbo psichiatrico o stato mentale alterato che preclude il consenso informato o gli esami correlati al protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who prefer tivozinab Hydrocloride or sutinib
    porzione di pazienti che preferisce tivozinab cloriodrato o sutinib
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 25 weeks
    a 25 settimane
    E.5.2Secondary end point(s)
    safety and tolerability during the course of the study
    sicurezza e tllerabilità durante la sperimentazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 25 weeks
    a 25 settimane
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    questionari sulla qualità della vita
    preferenza dei soggetti per tivozanib verso sunitinib
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    sunitinib
    sunitinib
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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 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
    last Visit last Subject
    Ultima visita ultimo soggetto
    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 months18
    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 months18
    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: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 160
    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)
    subjects continuing on tivozanib will have the oportunity to participate in a Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols subjects continuing on sutent will receive drug off study
    I soggetti che prediligeranno tivozanib avranno la possibilità di partecipare ad uno studio di roll-over che consentirà loro di continuare il trattamento con tivozanib; i soggetti che prediligeranno sutent riceveranno il farmaco come da normale pratica clinica, al di fuori da ogni studio clinico
    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 Decision2013-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-07-19
    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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