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    Summary
    EudraCT Number:2005-004078-25
    Sponsor's Protocol Code Number:VEG105192
    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:2006-08-03
    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 number2005-004078-25
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients with Locally Advanced and/or Metastatic Renal Cell Carcinoma Who Have Progressed Following Cytokine-based First-line Treatment
    Studio di fase III, multicentrico, randomizzato, in doppio cieco, controllato con placebo mirato a valutare l'efficacia e la tollerabilita` di Pazopanib (GW786034) rispetto a placebo in pazienti con carcinoma a cellule renali localmente avanzato e/o metastatico in progressione dopo terapia di prima linea con citochine.
    A.4.1Sponsor's protocol code numberVEG105192
    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 SponsorGLAXO SMITH KLINE RESEARCH & DEVELOPMENT LTD
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development
    B.5.2Functional name of contact pointCLINICAL TRIALS HELPDESK di GSK R&D
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road
    B.5.3.2Town/ cityStockley Park, Uxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number800786766 o +44 20 8990 4466
    B.5.5Fax number800786766 o +44 20 8990 4466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 namePazopanib
    D.3.2Product code GW786034
    D.3.4Pharmaceutical form 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 INNPazopanib
    D.3.9.1CAS number 635702-64
    D.3.9.2Current sponsor codeGW786034B
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number200
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    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 namePazopanib
    D.3.2Product code GW786034
    D.3.4Pharmaceutical form 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 INNPazopanib
    D.3.9.1CAS number 635702-64
    D.3.9.2Current sponsor codeGW786034B
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number400
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Locally advanced and/or metastatic renal carcinoma.
    Carcinoma a cellule renali in stadio localmente avanzato e/o 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 10061482
    E.1.2Term Renal neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate and compare progression free survival (PFS) of patients treated with pazopanib to those treated with placebo.
    Valutare e confrontare la sopravvivenza libera da malattia (PFS) dei pazienti trattati con Pazopanib e di quelli trattati con placebo.
    E.2.2Secondary objectives of the trial
    The principal secondary objective is: •To compare overall survival (OS) of patients treated with pazopanib to those treated with placebo. Other secondary objectives are: •To compare overall response rate [ORR = complete response (CR) + partial response (PR)] in patients treated with pazopanib to those treated with placebo. •To compare the rate of CR + PR + 6-months stable disease (SD) in patients treated with pazopanib to those treated with placebo. •To assess the incidence, severity and causality of all adverse events (AE), serious adverse events (SAEs) and other safety parameters in patients treated with pazopanib and placebo.
    Il principale obiettivo secondario e`: • Confrontare la sopravvivenza globale (OS) dei pazienti trattati con Pazopanib e di quelli trattati con placebo.Altri obiettivi secondari: • Confrontare la percentuale di risposta globale [ORR = risposta completa (CR) + risposta parziale (PR)] dei pazienti trattati con Pazopanib e di quelli trattati con placebo.• Confrontare la percentuale di CR + PR + malattia stabile (SD) per 6 mesi dei pazienti trattati con Pazopanib e in quelli trattati con placebo.• Valutare l'incidenza,la gravita` e la causa di tutti gli eventi avversi (AE),degli eventi avversi gravi (SAE) e di altri parametri di sicurezza nei pazienti trattati con Pazopanib e con placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed written consent form. 2) Diagnosis of clear cell RCC that is predominantly clear cell histology. 3) Locally advanced and/or metastatic RCC (equivalent to Stage IV RCC according to AJCC staging. 4) Must have measurable disease, i.e. presenting with at least one measurable lesion per RECIST. A measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter >20mm using conventional techniquest, or >10 mm with spiral CT scan. 5) Documented disease progression (based on radiographic imaging) following a first-line cytokine-based systemic treatment for locally advanced or metastatic RCC. The first-line cytokine-based treatment can be interleukin-2 (IL -2) or interferon-alpha (INF-alpha) monotherapy, or IL-2 or INF-alpha in combination with chemotherapy. 6) Male or female >21 years of age. 7) ECOG PS 0 or 1. 8) Adequate baseline organ function as defined in the protocol. 9)At least 4 weeks must have elapsed since the last surgery and 2 weeks must have elapsed since radiotherapy or the last systemic cytokine therapy. 10)Complete recovery from prior surgery, and/or reduction of all AEs to Grade 1 from prior systemic therapy or radiotherapy.
    1)Firma del consenso informato scritto.2)Diagnosi di RCC a cellule chiare con prevalenza di tipo istologico a cellule chiare. 3) RCC localmente avanzato e/o metastatico (equivalente a RCC di Stadio IV secondo la classificazione AJCC). 4) Malattia misurabile, ovvero almeno una lesione misurabile secondo RECIST. Una lesione misurabile e` definita come una lesione con almeno una dimensione misurabile con precisione, con diametro &gt; 20mm con l'uso di tecniche convenzionali o &gt; 10mm con TAC spirale. 5) Progressione documentata della malattia (in base alle immagini radiologiche) in seguito a trattamento sistemico di prima linea con citochine per l'RCC localmente avanzato o metastatico. Il trattamento di prima linea con citochine puo` essere una monoterapia con interleuchina-2 (IL-2) o interferone-alfa (INFalfa); oppure IL-2 o INF-alfa; in combinazione con chemioterapia. 6) Uomo o donna con eta` &gt;= 21 anni. 7)ECOG PS 0 o 1. 8)Funzionalita` organica basale adeguata. 9)Devono essere trascorse almeno 4 settimane dall'ultimo intervento chirurgico e 2 settimane dalla radioterapia o dall'ultima terapia sistemica con citochine. 10)Completo recupero da intervento chirurgico precedente e/o riduzione al Grado 1 di tutti gli AE provocati da terapia sistemica o radioterapia precedenti.
    E.4Principal exclusion criteria
    1)Pregnant or lactating female. 2)History of another malignancy. 3)History or presence of central nervous system (CNS) metastasis or leptomeningeal tumors as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam. 4) Malabsorption syndrome or disease that significantly affects gastrointestinal function, or major resection of the stomach or small bowel that could affect the absorption of pazopanib. 5)Unable to swallow and retain orally administered medication. 6) Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning study treatment. 7)History of human immunodeficiency virus infection. 8) Presence of uncontrolled infection. 9)Corrected QT interval (QTc) prolongation defined as QTc interval > 470 msecs. 10)History of Class III or IV congestive heart failure according to New York Heart Association (NYHA) classification [See Section 14.5 Appendix 5 for description].11)History of any one of the following cardiac conditions within the past 6 months: •Cardiac angioplasty or stenting, or •Myocardial infarction, or •Unstable angina.12)History of cerebrovascular accident within the past 6 months. 13)Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >=140mmHg, or diastolic blood pressure (DBP) of >= 90mmHg]. 14) History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. a calf vein thrombosis that is not treated). 15)Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease. 16)Evidence of bleeding diathesis or coagulopathy.17)Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study. 18) Has taken any prohibited medications that are listed in Section 8.2 within 14 days of the first dose of study medication. 19) Current or prior use of an investigational anti-cancer drug within 4 weeks of start of study.20)Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafinib, etc).
    1.Donna in gravidanza o allattamento. 2.Storia di un altro tumore maligno. 3.Storia di metastasi al sistema nervoso centrale (SNC) o tumori leptomeningei documentata da TAC o RMN, analisi del liquido cerebrospinale o esame neurologico. 4.Sindrome o malattia da malassorbimento che influisce in modo significativo sulla funzione gastrointestinale, o resezione maggiore dello stomaco o dell'intestino tenue che puo` influire sull'assorbimento di Pazopanib. 5.Incapacita` a deglutire o trattenere farmaci somministrati oralmente. 6.Ulcera peptica attiva, malattia infiammatoria intestinale, colite ulcerosa o altra patologia gastrointestinale con accresciuto rischio di perforazione; storia di fistola addominale, perforazione gastrointestinale o ascesso intra-addominale nelle 4 settimane precedenti l'inizio del trattamento in studio. 7.Storia di infezione da virus dell'immunodeficienza umana. 8.Infezione incontrollata. 9.Prolungamento dell'intervallo QT corretto (QTc) definito come intervallo QTc &gt; 470 msec. 10.Storia di insufficienza cardiaca congestizia di Classe III o IV secondo la classificazione della New York Heart Association (NYHA). 11.Storia di una delle seguenti condizioni cardiache nei 6 mesi che precedono l'ingresso in studio: •Angioplastica o stenting cardiaco, oppure •Infarto miocardico, oppure •Angina instabile. 12.Storia di incidente cerebrovascolare nei 6 mesi precedenti. 13.Ipertensione mal controllata [definita come pressione sanguigna sistolica (SBP) ‚³140 mmHg, o pressione sanguigna diastolica (DBP) ‚³ 90 mmHg].14.Storia di trombosi venosa profonda (TVP) non trattata nei 6 mesi precedenti (es. TVP del polpaccio non trattata). 15.Presenza di ferita, frattura o lesione ulcerativa di difficile guarigione, o presenza di malattia vascolare periferica sintomatica. 16.Evidenze di diatesi emorragica o coagulopatia. 17.Condizione medica, psichiatrica o di altro genere grave e/o instabile preesistente che potrebbe interferire con la sicurezza del/la paziente, l'ottenimento del consenso informato o la compliance. 8.Assunzione di farmaci non consentiti, elencati nel Capitolo 8.2 nei 14 giorni precedenti la prima dose del farmaco in studio. 19.Uso corrente o precedente di un farmaco antitumorale in fase sperimentale nelle 4 settimane precedenti l'inizio dello studio.20.Uso precedente di un farmaco sperimentale o autorizzato che ha come target il VEGF o i recettori di VEGF (es. bevacizumab, sutinib, sorafinib, ecc.).
    E.5 End points
    E.5.1Primary end point(s)
    PFS defined as the interval between the date of randomization and the earliest date of disease progression (as defined by the independent reviewer) or death due to any cause.
    La PFS definita come l'intervallo tra la data di randomizzazione e la data della prima rilevazione di progressione della malattia (definita dal revisore indipendente) o il decesso per qualsiasi causa.
    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 No
    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 concerned8
    E.8.5The trial involves multiple Member States No
    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
    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 months44
    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 months44
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-08-03. Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 350
    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)
    Come specificato nella sezione 9.3 del protocollo, alla conclusione dello studio i pazienti verranno trattati a discrezione dello sperimentatore, secondo il `local standard of care`.
    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 Decision2006-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
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