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    Summary
    EudraCT Number:2009-013407-66
    Sponsor's Protocol Code Number:AV-951-09-901
    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:2012-10-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-013407-66
    A.3Full title of the trial
    A Rollover Protocol to Allow Continued Access to Tivozanib (AV-951) for Subjects Enrolled in Other Tivozanib Protocols
    Protocollo roll-over per l'accesso continuato a tivozanib (AV-951) per i soggetti arruolati in altri protocolli con tivozanib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Protocol to Allow Continued Access to Tivozanib for Subjects Enrolled in Other Tivozanib Protocols
    Protocollo per l’accesso continuato a tivozanib per i soggetti arruolati in altri protocolli con tivozanib
    A.4.1Sponsor's protocol code numberAV-951-09-901
    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 code02139
    B.5.3.4CountryItaly
    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 NA
    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.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 renal cell carcinoma
    CARCINOMA METASTATICO DELLE CELLULE RENALI
    E.1.1.1Medical condition in easily understood language
    Renal Cancer
    CANCRO RENALE
    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 allow continued access to tivozanib for subjects who have participated in study AV-951-12-205, who are tolerating study drug and displaying clinical benefit.
    Consentire l’accesso continuato a tivozanib per i soggetti che hanno partecipato allo studio AV-951-12-205, che tollerano il farmaco dello studio e mostrano benefici clinici.
    E.2.2Secondary objectives of the trial
    To assess long-term safety and tolerability in subjects who continue on tivozanib To determine the duration of response and progression-free survival(PFS) of subjects who continue on tivozanib
    Valutare la sicurezza e la tollerabilità a lungo termine nei soggetti che continuano l’assunzione di tivozanib. Determinare la durata della risposta e la sopravvivenza libera da progressione (progression-free survival, PFS) dei soggetti che continuano l’assunzione di tivozanib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject must have received tivozanib while enrolled in another protocol, must be tolerating study drug and must currently display clinical benefit. The length of time that a subject must be on the parent protocol before rolling over to this protocol will be dictated by the parent protocol (AV-951-12-205). 2. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment. 3. Ability to give written informed consent
    1. Il soggetto deve aver ricevuto tivozanib mentre era arruolato in un altro protocollo, deve tollerare il farmaco dello studio e mostrare attualmente benefici clinici. 2. Se di sesso femminile e fertile, deve presentare documentazione di test di gravidanza negativo, prima dell’arruolamento. 3. Capacità di fornire il consenso informato scritto.
    E.4Principal exclusion criteria
    1. > 4 weeks since discontinuation of tivozanib treatment on a previous protocol 2. If female, pregnant or lactating 3. Sexually active male and pre-menopausal female subjects (and their partners) unless they agree to use adequate contraceptive measures, while on study and for 30 days after the last dose of study drug. All fertile male and female subjects (and their partners) must agree to use a highly effective method of contraception. Highly effective birth control includes (a) IUD plus one barrier method; or (b) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). (Note: Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are not considered effective for this study.) 4. Uncontrolled hypertension: systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 24 hours apart. 5. Newly identified CNS malignancies or documented progression of CNS metastases; subjects will be allowed only if the CNS metastases have been adequately treated with radiotherapy or surgery. For subjects receiving steroid therapy please refer to Section 6.3 for allowed steroid maintenance therapy. 6. Unhealed wounds (including active peptic ulcers) 7. Serious/active infection or infection requiring parenteral antibiotics 8. Life-threatening illness or organ system dysfunction compromising safety evaluation 9. Psychiatric disorder, altered mental status precluding informed consent or necessary testing 10. Inability to comply with protocol requirements
    1.&gt; 4 settimane dall’interruzione del trattamento con tivozanib in un protocollo precedente. 2.Donne incinte o in lattazione. 3.Soggetti di sesso maschile e femminile premenopausali (e i loro partner), salvo che questi acconsentano ad adottare misure contraccettive adeguate durante lo studio e nei 30 giorni successivi all’ultima dose di farmaco dello studio. Tutti i soggetti fertili di sesso maschile e femminile (e i loro partner) devono acconsentire a utilizzare un metodo contraccettivo altamente efficace. Il controllo efficace delle nascite comprende (a) dispositivo intrauterino (IUD) più un metodo di barriera; oppure (b) 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). (Nota: contraccettivi orali, impiantabili o iniettabili potrebbero essere influenzati dalle interazioni con il citocromo P450 e non sono considerati efficaci per questo studio). 4.Ipertensione non controllata: pressione sanguigna sistolica &gt; 140 mmHg o pressione sanguigna diastolica &gt; 90 mmHg trattata con 2 o più farmaci antipertensivi, documentata da 2 misurazioni consecutive eseguite ad almeno 24 ore di distanza. 5.Tumori maligni al sistema nervoso centrale (SNC) di recente identificazione o progressione documentata di metastasi al SNC; i soggetti saranno ammessi solamente se le metastasi al SNC sono state trattate adeguatamente con radioterapia o chirurgia. Per i soggetti che ricevono terapia steroidea, cfr. Sezione 6.3 per la terapia di mantenimento con steroidi consentita. 6.Ferite non rimarginate (incluse ulcere peptiche attive). 7.Infezione grave/attiva o infezione che necessita di antibiotici parenterali. 8.Patologia potenzialmente letale o disfunzione organica che compromette le valutazioni di sicurezza. 9.Disturbo psichiatrico, stato mentale alterato che preclude il consenso informato o gli esami necessari 10.Incapacità di attenersi ai requisiti previsti dal protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Tivozanib treatment in this study may be continued in the absence of disease progression or intolerable toxicities, or until tivozanib is commercially available in the country where the subject is being treated
    Il trattamento con tivozanib in questo studio potrà essere continuato in assenza di progressione di malattia o tossicità intollerabili, oppure fino a quando tivozanib non divenga disponibile sul mercato nel Paese in cui il soggetto viene trattato.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    Non applicabile
    E.5.2Secondary end point(s)
    Not present
    Non presente
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Non applicabile
    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 No
    E.6.7Pharmacodynamic No
    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
    allow continued access to tivozanib
    Consentire l’accesso continuato a tivozanib
    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 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 tratment visit of the last subject at the last site. Tivozanib treatment in this study may be continued until tivozanib is commercially available.
    Ultima visita di trattamento dell'ultimo soggetto nell'ultimo centro. Il trattamento con tivozanib in questo studio potrà essere continuato fino a quando tivozanib non divenga disponibile sul mercato.
    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 months12
    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 months12
    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)
    Not Applicable
    Non applicabile
    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 Decision2013-02-26
    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 StatusCompleted
    P.Date of the global end of the trial2015-04-28
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