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    Summary
    EudraCT Number:2005-000051-15
    Sponsor's Protocol Code Number:A4061008
    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:2012-08-07
    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 number2005-000051-15
    A.3Full title of the trial
    CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2,
    AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN
    CLINICAL TRIALS
    ACCESSO CONTINUO ALL'INIBITORE DELLA TIROSIN-CHINASI DI VEGFR-2, AG-013736 (A406), PER PAZIENTI PRECEDENTEMENTE TRATTATI CON AG-013736 IN SPERIMENTAZIONI CLINICHE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2,
    AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN
    CLINICAL TRIALS
    ACCESSO CONTINUO ALL’INIBITORE DELLA TIROSIN-CHINASI DI VEGFR-2, AG-013736 (A406), PER PAZIENTI PRECEDENTEMENTE TRATTATI CON AG-013736 IN SPERIMENTAZIONI CLINICHE
    A.4.1Sponsor's protocol code numberA4061008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00828919
    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 SponsorPFIZER 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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinicalTrials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 7181021
    B.5.5Fax number001 303 7391119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.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 nameAxitinib
    D.3.2Product code AG-013736
    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 INNAXITINIB
    D.3.9.1CAS number 319460-85-0
    D.3.9.2Current sponsor codeAG-013736
    D.3.9.3Other descriptive nameIUPAC N-methyl-2-3((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl-benzamide
    D.3.9.4EV Substance CodeSUB25427
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 nameAxitinib
    D.3.2Product code AG-013736
    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 INNAXITINIB
    D.3.9.1CAS number 319460-85-0
    D.3.9.2Current sponsor codeAG-013736
    D.3.9.3Other descriptive nameIUPAC N-methyl-2-3((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl-benzamide
    D.3.9.4EV Substance CodeSUB25427
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Patients who have been treated in previous AG-013736 oncology studies.
    Pazienti già trattati con AG-013736 in precedenti sperimentazioni cliniche oncologiche
    E.1.1.1Medical condition in easily understood language
    Various solid tumor types
    Vari tipi di tumore solido
    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 10065143
    E.1.2Term Malignant solid tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    The objective of the trial is to provide continued access to AG-013736 tablets to patients who were assigned to an AG-013736-containing treatment arm in a previous AG-013736 trial and who had documented stable or responding disease at the time they discontinued in the trial. Continuing access will be provided to patients who have Progressive Disease (PD) but have experienced clinical benefit from previous AG-013736 treatment; in this case, clinical benefit is defined as the Sum of Longest Diameters (SLD) of measurable lesions remaining less than or equal to the baseline SLD in the previous AG-013736 trial. These patients must not be eligible for treatment with other available approved therapy for the disease under study.
    L’obiettivo della sperimentazione è di fornire un trattamento con AG-013736 in compresse a pazienti randomizzati in un braccio di trattamento contenente AG-013736 in un precedente studio clinico con la molecola con malattia stabile documentata o responsiva nel momento in cui hanno interrotto la sperimentazione. Il trattamento continuo sarà fornito a pazienti con malattia in progressione (PD), ma che hanno ricevuto un beneficio clinico dal precedente trattamento con AG-013736. In tal caso, si definisce beneficio clinico la somma dei diametri più lunghi (SLD) delle lesioni misurabili residue che sono rimaste inferiori o pari alla SLD basale nella precedente sperimentazione con AG-013736. Tali pazienti non devono essere eleggibili ad un trattamento con altre terapie approvate e disponibili per la patologia in studio.
    E.2.2Secondary objectives of the trial
    Not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:  Patients who were assigned to an AG-013736-containing treatment arm in a previous clinical trial.  Patients who were receiving AG-013736 tablets at the time their previous trial ended.  Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous AG-013736 protocol should be used to determine stable or responding disease).  Patients who have Progressive Disease (PD) but have experienced clinical benefit from previous AG-013736 treatment will be eligible for enrollment; in this case, clinical benefit is defined as the Sum of Longest Diameters (SLD) of measurable lesions remaining less than or equal to the baseline SLD in the previous AG-013736 trial. These patients must not be eligible for treatment with other available approved therapy for the disease under study. The Pfizer clinician must approve the enrollment prior to treatment start.  Patients who are informed of, and willing and able to comply with the investigational nature of the trial, and have signed a written informed consent in accordance with institutional and ICH GCP guidelines.
    I soggetti devono soddisfare tutti i seguenti criteri di inclusione per essere considerati eleggibili all’arruolamento nello studio: • Pazienti stati randomizzati ad un braccio di trattamento contenente AG-013736 in una precedente sperimentazione clinica. • Pazienti trattati con AG-013736 in compresse al momento della conclusione della loro precedente sperimentazione clinica. • Pazienti in malattia stabile (SD) o responsiva (PR o CR) documentata da opportuni esami radiologici, clinici e di laboratorio entro 12 settimane prima dell’arruolamento (Nota: Per determinare se la patologia sia stabile o responsiva, devono essere utilizzati i criteri di risposta del precedente protocollo con AG-013736). • I pazienti in progressione di malattia (PD), ma che hanno ricevuto un beneficio clinico dal precedente trattamento con AG-013736 ; in tal caso, si definisce beneficio clinico la somma dei diametri più lunghi (SLD) di lesioni misurabili residue inferiori o pari alla SLD basale nella precedente sperimentazione con AG-013736. Tali pazienti devono risultare non eleggibili ad un trattamento con altre terapie disponibili approvate per la patologia in studio. Il clinico di Pfizer deve approvare l’arruolamento prima dell’inizio del trattamento. • Pazienti disposti a rispettare l’aspetto sperimentale dello studio, in grado di farlo, ne siano stati informati ed abbiano firmato un consenso informato scritto in conformità alle linee guida istituzionali e delle ICH –GCP.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:  Patients may not participate in this trial if the conditions for continuing treatment in the previous AG-013736 protocol are not met.
    I pazienti che presentano qualsiasi dei seguenti aspetti non saranno inclusi nello studio: • Pazienti che non abbiano le condizioni per continuare il trattamento del precedente protocollo con AG-013736.
    E.5 End points
    E.5.1Primary end point(s)
    All patients will be assessed for safety by monitoring adverse events and laboratory values per
    standard clinical practice. Response to therapy will not be evaluated.
    In tutti i pazienti verrà valutato il profilo di sicurezza monitorando gli eventi avversi ed i parametri di laboratorio secondo la pratica clinica standard. Non sarà valutata la risposta alla terapia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All patients will be assessed for safety by monitoring adverse events and laboratory values per
    standard clinical practice. Response to therapy will not be evaluated.
    In tutti i pazienti verrà valutato il profilo di sicurezza monitorando gli eventi avversi ed i parametri di laboratorio secondo la pratica clinica standard. Non sarà valutata la risposta alla terapia.
    E.5.2Secondary end point(s)
    n/a
    n/a
    E.5.2.1Timepoint(s) of evaluation of this end point
    n/a
    n/a
    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 No
    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
    Continuation study for patients previously receiving AG-013736 in clinical trials
    studio di estensione per pazienti precedentemente trattati con AG-013736 in studi clinici
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) 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 trial0
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    End of trial in all participating countries is defined as the time at which all patients enrolled in the study have completed treatment on study.
    La fine delle sperimentazione in tutti i paesi partecipanti è definito come il momento in cui tutti i pazienti arruolati nello studio hanno completato il trattamento di studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years12
    E.8.9.2In all countries concerned by the trial months0
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 39
    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 Decision2012-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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