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    Summary
    EudraCT Number:2010-023377-19
    Sponsor's Protocol Code Number:D2610C00004
    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:2011-12-29
    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 number2010-023377-19
    A.3Full title of the trial
    A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE)
    Studio di Fase IIa, in aperto, randomizzato per valutare l'efficacia e la sicurezza di AZD4547 in monoterapia verso Paclitaxel in pazienti con tumore gastrico o alla giunzione gastro-esofagea avanzato, con polisomia o amplificazione del gene FGFR2 (Studio Shine).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE)
    Studio di Fase IIa, in aperto, randomizzato per valutare l’efficacia e la sicurezza di AZD4547 in monoterapia verso Paclitaxel in pazienti con tumore gastrico o alla giunzione gastro-esofagea avanzato, con polisomia o amplificazione del gene FGFR2 (Studio Shine).
    A.3.2Name or abbreviated title of the trial where available
    SHINE
    SHINE
    A.4.1Sponsor's protocol code numberD2610C00004
    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 SponsorASTRAZENECA
    B.1.3.4CountryItaly
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressInformation Centre
    B.5.3.2Town/ cityInformation Centre
    B.5.3.3Post codeInformation
    B.5.3.4CountrySweden
    B.5.4Telephone numberInformation Centre
    B.5.6E-mailinformation.centre@astrazeneca.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 nameAZD4547
    D.3.2Product code AZD4547
    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.3.9.1CAS number 1035270-39-3
    D.3.9.2Current sponsor codeAZD4547
    D.3.9.3Other descriptive nameN-[5-[2-(3,5-dimethoxyphenyl)ethyl]-1Hpyrazol-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.2.1.1.1Trade name TEVA UK
    D.2.1.1.2Name of the Marketing Authorisation holderUnited Kingdom
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    locally advanced or metastatic gastric adenocarcinoma that has FGFR2 polysomy or FGFR2 gene amplification who have relapsed or have not responded, following one prior chemotherapeutic regimen.
    adenocarcinoma gastrico localmente avanzato o metastatico che presentano polisomia dell’ FGFR2 o amplificazione dell’ FGFR2 che hanno recidivato o non hanno risposto dopo un precedente regime chemioterapeutico.
    E.1.1.1Medical condition in easily understood language
    stolocally advanced or metastatic gastric adenocarcinomamach and food-pipe cancer, anti-tumour activity, high number of
    copies of gene driving cancer
    adenocarcinoma gastrico localmente avanzato 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 HLT
    E.1.2Classification code 10017812
    E.1.2Term Gastric neoplasms malignant
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the relative efficacy of AZD4547 compared with paclitaxel by
    comparison of the change in tumour size at 8 weeks in all randomised
    patients and also in the patients with tumours that have FGFR2
    amplification (FISH score 6) alone.
    Valutare l’ efficacia relativa di AZD4547 verso paclitaxel confrontando il cambiamento nelle dimensioni del tumore alla settimana 8 in tutti i pazienti randomizzati e anche nei pazienti con tumore che presenta solo amplificazione dell’ FGFR2 (FISH score 6).
    E.2.2Secondary objectives of the trial
    To assess the relative efficacy of AZD4547 compared with paclitaxel by assessment of PFS in all randomised patients and also in the patients with tumours that have FGFR2 amplification alone. To investigate the efficacy of AZD4547 compared with paclitaxel by assessment of ORR in all randomised patients and also in the patients with tumours that have FGFR2 amplification alone To assess the efficacy of AZD4547 and paclitaxel by assessment of the percentage of patients without progressive disease at 8 weeks.
    To compare and assess the safety and tolerability of AZD4547 and paclitaxel. To investigate the PK of AZD4547 in an advanced gastric cancer patient population. To investigate the possible PK/PD relationships between plasma AZD4547 exposure and plasma concentrations of phosphate, bFGF, FGF23 and efficacy and other exploratory PD endpoints.
    Valutare l’efficacia relativa di AZD4547 verso paclitaxel confrontando la sopravvivenza libera da progressione in tutti i pazienti randomizzati e anche nei pazienti con tumore che presenta solo amplificazione dell’FGFR2. Indagare l’efficacia di AZD4547 verso paclitaxel tramite la valutazione del tasso di risposta oggettiva in tutti i pazienti randomizzati e anche nei pazienti con tumore che presenta solo amplificazione dell’FGFR2. Valutare l’efficacia di AZD4547 e paclitaxel tramite la valutazione della percentuale di pazienti senza progressione di malattia alla settimana 8. Confrontare e valutare la sicurezza e la tollerabilità di AZD4547 e paclitaxel. Indagare la farmacocinetica di AZD4547 in pazienti con tumore gastrico avanzato. Indagare la possibile relazione PK/PD tra l’esposizione plasmatica di AZD4547 e la concentrazione plasmatica di fosfati, bFGF, FGF23 e efficacia e altri en
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female or male aged 25 or over
    Histological diagnosis of locally advanced or metastatic gastro
    adenocarcinoma (including adenocarcinoma of the lower third of the
    oesophagus or the gastro oesophageal junction )
    Radiographically confirmed progression after 1 prior chemotherapy or
    chemoradiotherapy for gastric cancer. Suitable for and expected to
    benefit from paclitaxel monotherapy.
    At least one lesion, not previously irradiated, that at baseline is equal to
    or larger than 10mm in the longest diameter for non nodal lesions with
    CT or MRI
    Provision of either an archival tumour sample or a fresh tumour sample
    for confirmation of FGFR2 polysomy/gene amplification by the sponsor
    approved laboratory. Patients with FGFR2 polysomy or gene amplified
    tumours will be eligible for the main study
    Uomini o donne di età uguale o superiore a 25 anni.
    Pazienti idonei ad assumere e ricevere beneficio da paclitaxel in monoterapia
    Conferma radiologica di progressione dopo una precedente chemioterapia o chemioradioterapia per tumore gastrico.
    Diagnosi istologica di adenocarcinoma gastrico localmente avanzato o metastatico (incluso adenocarcinoma del terzo tratto inferiore dell’esofago o della giunzione gastro-esofagea)
    Fornitura obbligatoria di biopsia tumorale archiviata o fresca per la conferma di tumore gastrico avanzato che presenta polisomia o amplificazione del gene FGFR2. Conferma da un laboratorio approvato da AstraZeneca
    Almeno una lesione, non irradiata precedentemente, di &gt; 10 mm al baseline nel diametro maggiore (eccetto i linfonodi che devono avere l’asse più corto di &gt; 15 mm) che possa essere accuratamente misurata con TAC o RMI e che sia idonea per una accurata misurazione ripetuta
    E.4Principal exclusion criteria
    Prior exposure to AZD4547 or history of hypersensitivity other drugs
    similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or
    formulated in Cremaphor EL (polyoxyethylated castor oil)
    Major surgery, radiotherapy with wide field of radiation or any cancer
    treatment within 4 weeks before the first dose of the study treatment
    With the exception of alopecia, any unresolved toxicities from prior
    therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at
    the time of starting study treatment.
    Blood and ECG readings that are deemed to be abnormal by falling
    outside of the reference ranges in the protocol inclusion/exclusion
    section.
    Taking other regular medication that are predicted to interact with
    AZD4547 due to their route of metabolism.
    Precedente esposizione ad AZD4547 o storia di ipersensibilità verso altri farmaci simili in struttura o classe ad AZD4547. Ipersensibilità a paclitaxel o altri farmaci formulati in Cremaphor EL. Chirurgia maggiore. Radioterapia con ampio campo di radiazione entro 4 settimane prima della prima dose di trattamento di studio. Con eccezione di alopecia, qualsiasi tossicità non risolta da precedenti terapie con grado CTCAE &gt;1 al momento di iniziare il trattamento dello studio. Esami del sangue ed ECG che sono considerate anormali essendo al di fuori dei range di riferimento stabiliti dai criteri di inclusione/esclusione del protocollo. Assunzione regolare di farmaci concomitanti che interferiscono con AZD4547 a causa della loro via di metabolizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of relative efficacy of AZD4547 compared with paclitaxel by comparison of the change in tumour size at 8 weeks in all patients and
    also in patients with FGFR2 amplified tumours (FISH 6) alone
    Valutare l’ efficacia relativa di AZD4547 verso paclitaxel confrontando il cambiamento nelle dimensioni del tumore alla settimana 8 in tutti i pazienti randomizzati e anche nei pazienti con tumore che presenta solo amplificazione dell’ FGFR2 (FISH score 6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Based on RECIST measurements taken at baseline and at week 8.
    Secondo la misurazione RECIST al baseline e alla settimana 8.
    E.5.2Secondary end point(s)
    Relative efficacy of AZD4547 compared with paclitaxel by assessment of
    progression free survival (defined by RECIST 1.1 or death), in all
    randomized patients and also in patients with FGFR2 amplified tumours
    (FISH 6) alone
    Efficacy of AZD4547 compared with paclitaxel by assessment of
    objective response rate (1 visit response of CR or PR prior to progression
    as defined by RECIST 1.1) in randomized patients and also in patients
    with FGFR2 amplified tumours (FISH 6) alone
    Assess the efficacy of AZD4547 and paclitaxel by assessment of the
    percentage of patients without progressive disease at 8 weeks
    Safety and tolerability of AZD4547 versus paclitaxel by assessing safety
    information (lab findings, ECG, adverse events, deaths, physical
    examination, eye asssessments and MUGA/Echo parameters)
    Investigate PK of AZD4547 in advanced gastric cancer patient
    population.
    Valutare l’efficacia relativa di AZD4547 verso paclitaxel confrontando la sopravvivenza libera da progressione in tutti i pazienti randomizzati e anche nei pazienti con tumore che presenta solo amplificazione dell’FGFR2 (FISH score 6).
    Indagare l’efficacia di AZD4547 verso paclitaxel tramite la valutazione del tasso di risposta oggettiva in tutti i pazienti randomizzati e anche nei pazienti con tumore che presenta solo amplificazione dell’FGFR2 (FISH score 6).
    Valutare l’efficacia di AZD4547 e paclitaxel tramite la valutazione della percentuale di pazienti senza progressione di malattia alla settimana 8.
    Confrontare e valutare la sicurezza e la tollerabilità di AZD4547 e paclitaxel.
    Indagare la farmacocinetica di AZD4547 in pazienti con tumore gastrico avanzato
    E.5.2.1Timepoint(s) of evaluation of this end point
    RECIST assessments will be performed at baseline and every 8 weeks
    until progression.
    All safety measures will be collected from screening to 28 days after
    study drug discontinuation.
    Plasma AZD4547 measured as follows –
    Cycle 1 - Day 8 (pre), Day 15 (pre, 0.5-2, 5-6, 8-12 hrs)
    Cycle 2 - Day 1 (pre), Day 15 (pre, 0.5-2, 5-6, 8-12 hrs)
    Biomarker samples taken during screening, Cycle 1 Day 8 and Day 15,
    Cycle 3 Day 1 and Day 1 of each subsequent cycle.
    Investigate Possible pharmacokinetic/pharmacodynamic relationships
    between plasma AZD4547 and levels of phosphate, bFGF, FGF23, efficacy
    and other exploratory PD endpoints.
    Le misurazioni RECIST saranno effettuate al baseline e ogni 8 settimane fino a progression. Tutte le valutazioni di sicurezza sarrno raccolte dallo screening a 28 giorni dopo l’ interruzione del farmaco. Le misurazioni della concentrazione plasmatica di AZD4547 verranno effettuate come segue: Cicle 1 - giorno 8 (pre-dose), giorno 15 (pre-dose, 0.5-2, 5-6, 8-12 ore); Cicle 2 - giorno 1 (pre-dose), giorno 15 (pre-dose, 0.5-2, 5-6, 8-12 ore). I campioni per l’analisi dei .biomarcatori saranno presi durante lo screening, al ciclo 1, giorno 8 e 15, ciclo 3 giorno 1, e il giorno 1 di ogni successivo ciclo. Indagare la possibile relazione farmacocinetica/farmacodinamica tra l’esposizione plasmatica di AZD4547 e la concentrazione plasmatica di fosfati, bFGF, FGF23 e efficacia e altri en
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    India
    Korea, Democratic People's Republic of
    Korea, Republic of
    Taiwan
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 55
    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)
    standard
    standard
    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 Decision2011-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
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