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    Summary
    EudraCT Number:2012-004910-33
    Sponsor's Protocol Code Number:PAZOTEST-01
    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:2012-12-11
    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 number2012-004910-33
    A.3Full title of the trial
    Phase II study of single-agent Pazopanib (Votrient) for patients with relapsed or refractory germ-cell tumors (GCT).
    Studio di fase II con ™inibitore tirosin-kinasico Pazopanib in pazienti affetti da neoplasie germinali ricaduti o refrattari.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pazopanib for advanced and chemorefractory germ-cell tumors.
    Pazopanib nelle neoplasie germinali pre-trattate ricadute e chemiorefrattarie.
    A.3.2Name or abbreviated title of the trial where available
    PAZOTEST-01
    PAZOTEST-01
    A.4.1Sponsor's protocol code numberPAZOTEST-01
    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 SponsorISTITUTO NAZIONALE PER LA CURA TUMORI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori
    B.5.2Functional name of contact pointOncologia Medica 2
    B.5.3 Address:
    B.5.3.1Street Addressvia G. Venezian 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number02 2390 2402
    B.5.5Fax number02 2390 3150
    B.5.6E-mailurologia@istitutotumori.mi.it
    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 Yes
    D.2.1.1.1Trade name VOTRIENT*FL 30CPR RIV 200MG
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical 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 444731-52-6
    D.3.9.4EV Substance CodeSUB29175
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 typefarmaco antiangiogenetico
    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
    Testicular or extragonadal germ cell tumors.
    Neoplasie germinali del testicolo o extragonadiche.
    E.1.1.1Medical condition in easily understood language
    Germ cell tumors which are not cured by prior chemotherapy regimens.
    Neoplasie germinali avanzate che non sono guarite con precedenti trattamenti chemioterapici.
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10018187
    E.1.2Term Genitourinary neoplasms malignancy and gender unspecified
    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 evaluate the activity of Pazopanib in a population of patients with pre-treated germ cell tumors.
    Primary endpoint: 3-month progression-free survival
    Valutare l'attività di pazopanib in una popolazione di pazienti affetti da neoplasie germinali pre-trattate con chemioterapia.
    Endpoint primario: Sopravvivenza libera da progressione a 3 mesi.
    E.2.2Secondary objectives of the trial
    Overall survival.
    Response-rate.
    Safety and tolerability.
    Sopravvivenza globale.
    Numero di risposte obiettive.
    Sicurezza e tollerabilità.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    To evaluate the role of PET/CT in detecting tumor sites and evaluate response to pazopanib.
    ALTRI SOTTOSTUDI:
    Studio del ruolo della PET/TC nel diagnosticare le localizzazioni di malattia e valutare la risposa a pazopanib nelle neoplasie germinali.
    E.3Principal inclusion criteria
    - Age > 18 years.
    - Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
    - A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease (enrollment will take place either as 3rd or 4th line of treatment), EXCEPT FOR primary mediastinal nonseminomas, to which the 2nd line setting will apply.
    - First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.
    - Prior single, tandem or triple high-dose chemotherapy course given as front-line or salvage therapy is allowed.
    - Adequate hematopoietic and organ function.
    • Età ≥ 18 anni.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status &lt; 2.
    • Ricaduta/Progressione dopo 2 o 3 linee di trattamento chemioterapico cisplatino-contenente. Tale condizione è definita come un incremento o una persistente positività di uno o più marcatori tumorali o da un incremento numerico e/o dimensionale di localizzazioni vitali non teratomatose di malattia.
    • E’ ammesso un precedente trattamento chemioterapico ad alte dosi costituito da un singolo o multipli cicli di chemioterapia seguiti da reinfusione di progenitori emopoietici autologhi.
    • E’ ammesso il trattamento con pazopanib in setting di seconda linea (dopo fallimento di I linea costituita da almeno 3 cicli di chemioterapia cisplatino-contenente) ESCLUSIVAMENTE per i pazienti con neoplasie germinali nonseminomatose primitive del mediastino.
    • Diagnosi istologica e/o clinica di neoplasia germinale del testicolo o extragonadica.
    • Adeguata funzionalità midollare e d’organo
    E.4Principal exclusion criteria
    1. Significant comorbidities that preclude the administration of Pazopanib.
    2. Severe ongoing infections, grade > 2 of the CTCAE v.4.03..
    4. Patients with late-relapse (defined as relapse occurring after at least 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are ineligible. In general, these patients are recommended for initial surgical extirpation rather than chemotherapy or other drugs. Patients with late relapse who have either unresectable disease or highly elevated markers will be eligible.
    5. More than 3 prior chemotherapy regimens.
    6. Prior cancer except for basal cell carcinoma and any other cancer that has been cured since 5 years before.
    7. Any medical and psychiatric conditions that could jeopardize the observation of protocol procedures.
    • Co-morbidità significative che compromettono l’esecuzione in sicurezza del trattamento con pazopanib.
    • Infezioni gravi in atto (di grado &gt; 2 NCI-CTC versione 4.03).
    • Pazienti con LATE RELAPSE (definita come recidiva di malattia dopo 2 anni dal termine del trattamento chemioterapico di I linea) e con malattia radicalmente resecabile. I pazienti con malattia non radicalmente operabile sono candidabili allo studio.
    • Più di 3 linee di trattamento chemioterapico precedenti (salvo i casi in cui i pazienti hanno ricevuto 2 differenti regimi di trattamento chemioterapico come parte della I linea di chemioterapia. Ad esempio pazienti trattati con 2 cicli PEB e successivamente con 2 cicli PEI per tossicità polmonare possono essere arruolabili, così come i pazienti che hanno ricevuto 4 cicli PEB e successivamente, dopo asportazione di malattia attiva, altri 2 cicli PEB di consolidamento).
    • Neoplasie precedenti o concomitanti differenti da quella in trattamento fatta eccezione per il carcinoma basocellulare o per ogni precedente neoplasia diagnosticata e curata almento 5 anni prima dell’ingresso nello studio.
    • Ogni condizione medica, psichiatrica o dipendenza che può compromettere l’osservanza delle indicazioni previste nello studio.
    E.5 End points
    E.5.1Primary end point(s)
    3-month PFS
    Sopravvivenza libera da progressione a 3 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    E.5.2Secondary end point(s)
    Safety and tolerability.
    Overall survival.
    Response rate.
    Sicurezza e tollerabilità.
    Sopravvivenza globale.
    Tasso di risposte.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi.
    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 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) 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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    Trial ending 3 months after the LPFV.
    Chiusura del trial a 3 mesi di follow up dell'ultimo soggetto a partire dalla data del LPFV.
    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 months24
    E.8.9.1In the Member State concerned 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: 43
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state43
    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)
    Clinical and imaging follow up for responsive patients.
    Starting of further line therapies for unresponsive-progressive patients.
    Follow up periodico clinico-strumentale per i pazienti in remissione di malattia.
    Inizio di programmi di trattamento con ulteriori chemioterapie per pazienti in progressione di malattia.
    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 Decision2012-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-27
    P. End of Trial
    P.End of Trial StatusCompleted
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