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    Summary
    EudraCT Number:2011-002424-41
    Sponsor's Protocol Code Number:OGX-427-02
    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:2012-04-03
    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 number2011-002424-41
    A.3Full title of the trial
    A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination with OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma
    Studio randomizzato, in doppio cieco, di Fase 2 per confrontare gemcitabina e cisplatino in combinazione con OGX-427 o placebo nei pazienti affetti da carcinoma a cellule transizionali avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The trial is designed to determine the efficacy of OGX-427 Vs placebo in combination with Gemcitabine and Cisplatin in patients with Urinary tract cancer.
    La sperimentazione e' stata progettata per determinare l'efficacia di OGX-427 vs placebo in combinazione con Gemcitabina e Cisplatino nei pazienti con cancro del tratto urinario.
    A.4.1Sponsor's protocol code numberOGX-427-02
    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 SponsorONCOGENEX TECHNOLOGIES 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 supportOncoGenex Technologies Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncoGenex Technologies Inc.
    B.5.2Functional name of contact pointMonica Krieger
    B.5.3 Address:
    B.5.3.1Street Address1522 217th Place SE, Suite 100
    B.5.3.2Town/ cityBothell, Washington
    B.5.3.3Post code98021
    B.5.3.4CountryUnited States
    B.5.4Telephone number1 425 686 1558
    B.5.5Fax number1 425 686 1600
    B.5.6E-mailMKrieger@oncogenex.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 nameOGX-427
    D.3.2Product code NA
    D.3.4Pharmaceutical form 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.3.9.1CAS number 915443-09-3
    D.3.9.2Current sponsor codeOGX-427
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic or locally inoperable, advanced (T4b, N2, N3 or M1)
    transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra,
    ureter and renal pelvis)
    Carcinoma a cellule transizionali (TCC) con malattia metastatica o localmente inoperabile, avanzata (T4b, N2, N3 o M1), del tratto urinario (vescica, uretra, uretere e pelvi renale)
    E.1.1.1Medical condition in easily understood language
    Metastatic or locally inoperable, advanced Urinary tract cancer
    Carcinoma avanzato del tratto urinario, metastatico o localmente avanzato
    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 10005084
    E.1.2Term Bladder transitional cell carcinoma
    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
    To ascertain whether there is evidence of longer survival relative to the
    control arm for three comparisons: 600 mg OGX-427 Arm to control Arm;
    1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg
    OGX-427 Arms to control Arm.
    Stabilire se esistano le prove di una sopravvivenza più lunga relativa al braccio di controllo per i tre raffronti: Braccio da 600 mg OGX-427 versus Braccio di controllo; Braccio da 1000 mg OGX-427 versus Braccio di controllo; e Bracci combinati da 600 mg e 1000 mg OGX-427 versus Braccio di controllo.
    E.2.2Secondary objectives of the trial
    • To compare safety and tolerability of placebo, 600 mg of OGX-427,
    and 1000 mg of OGX-427 in combination with gemcitabine+cisplatin
    • To select the optimal dose of OGX-427 for Phase 3 studies based on the safety and efficacy
    • To compare ORR, disease control rate, duration of response and PFS between the arms
    • To evaluate the effect of therapy with gemcitabine, cisplatin and OGX-
    427 on serum Hsp27 levels, serum clusterin levels and CTC counts
    • To evaluate and compare the number of circulating tumor cells at baseline, the minimum CTC count during treatment and the maximum
    change in CTC count over time between arms
    • To evaluate the effect of repeat OGX-427 dosing on serum OGX-427
    Cmax and trough levels
    • To evaluate for PTEN loss, translocation, or deletion, along with
    downstream targets, in correlation with clinical response and changes in
    clusterin and Hsp27 levels
    • Confrontare sicurezza e tollerabilità di placebo 600mg OGX-427 e 1000mg OGX-427 in combinazione con gemcitabina+cisplatino
    • Selezionare dose ottimale OGX-427 per studi di Fase 3 in base a sicurezza ed efficacia
    • Confrontare ORR, tasso di controllo della malattia, durata della risposta e sopravvivenza libera da malattia tra i bracci
    • Valutare effetto della terapia con gemcitabina cisplatino e OGX-427 sui livelli sierici Hsp27 clusterina e conte CTC
    • Valutare e confrontare n. cellule tumorali circolanti al basale conta CTC minima durante trattamento e cambiamento max nella conta CTC nel tempo tra i bracci
    • Valutare effetto dosaggi ripetuti di OGX-427 su livelli sierici di OGX-427 Cmax e attraverso gli altri livelli
    • Valutare perdita PTEN traslocazione o delezione unitamente a obiettivi a valle in relazione a risposta clinica e variazioni nei livelli di Hsp27 e clusterina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically documented metastatic or locally inoperable, advanced (T4b, N2, N3 or M1) TCC of the urinary tract (bladder, urethra, ureter and renal pelvis)
    NOTE: Certain mixed histologies that are predominately (≥ 50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated. Mixed undifferentiated histology requires IHC consistent with a TCC origin. Mixed small-cell histologies are excluded.
    • Measurable disease according to RECIST 1.1.
    • No prior systemic chemotherapy with the following exceptions:
    o Prior history of radiosensitizing single agent therapy is allowed.
    o Prior neoadjuvant and adjuvant systemic chemotherapy are permissible if the interval from the end of therapy to the diagnosis of metastatic disease is at least 12 months.
    • Karnofsky performance status ≥70%.
    • Required laboratory values at baseline:
    o ANC ≥ 1.5 x 109 cells/L and platelet count ≥ 125 x 109/L.
    o calculated creatinine clearance ≥60 mL/minute according to the modified Cockcroft-Gault formula.
    o bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 3.0 x ULN.
    • TCC istologicamente documentato metastatico o localmente inoperabile avanzato (T4b, N2, N3 o M1), del tratto urinario (vescica, uretra, uretere e pelvi renale)
    NOTA: sono eleggibili alcune istologie miste prevalentemente con TCC (≥ 50%): squamose, adenocarcinoma e indifferenziate. L’istologia mista indifferenziata richiede IHC consistente con un’origine TCC. Sono escluse le istologie miste a cellule piccole.
    • Patologia misurabile in base a RECIST 1.1.
    • Nessuna precedente chemioterapia sistemica con le seguenti eccezioni:
    o È permessa un’anamnesi di monoterapia radiosensibilizzante.
    o La precedente chemioterapia sistemica neoadiuvante e adiuvante è ammissibile se l’intervallo dalla fine della terapia alla diagnosi di patologia metastatica è di almeno 12 mesi.
    • Karnofsky perfomance status ≥ 70%.
    • Valori di laboratorio necessari al basale:
    o ANC ≥ 1,5 x 109 cellule/ll e conteggio delle piastrine ≥ 125 x 109/ll.
    o clearance della creatinina calcolata ≥ 60 ml/minuto in base alla formula Cockcroft-Gault modificata.
    o bilirubina ≤ 1,5 x ULN; AST e ALT ≤ 3,0 x ULN.
    E.4Principal exclusion criteria
    • A candidate for potential curative surgery or radiotherapy.
    • Intravesicular therapy within the past 3 months.
    • Documented brain metastasis or carcinomatous meningitis, treated or untreated.
    • Peripheral neuropathy ≥Grade 2.
    • Cerebrovascular accident, myocardial infarction, or pulmonary embolus within 6 months of randomization.
    • Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.
    • Un candidato a radioterapia o chirurgia curativa
    • Terapia intravescicale nel corso degli ultimi 3 mesi.
    • Metastasi del cervello o meningite carcinomatosa documentate, trattate o non trattate.
    • Neuropatia periferica ≥ Grado 2.
    • Incidente cerebrovascolare, infarto miocardico o embolo polmonare entro 6 mesi dalla randomizzazione.
    • Seconda neoplasia maligna attiva (ad eccezione del cancro della pelle non melanomatoso): per seconda neoplasia maligna attiva si intende un’attuale esigenza di terapia per il tumore o un’elevata possibilità (&gt;30%) di recidiva durante lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for each patient is overall survival time.
    L'end point primario di efficia per ciascun paziente è il tempo di sopravivenza complessivo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint for each patient is overall survival time
    measured as time from the date of randomization to the date of death
    from any cause. For patients still alive at the time of analysis, overall
    survival time will be censored on the date of last contact.
    L'endpoint primario di efficacia per ogni paziente è il tempo di sopravvivenza complessivo, misurato come tempo dalla data di randomizzazione alla data della morte per qualsiasi causa. Per i pazienti ancora in vita al momento delle analisi, in generale,
    il tempo di sopravvivenza sarà calcolato considerando la data dell'ultimo contatto.
    E.5.2Secondary end point(s)
    The secondary efficacy objectives include evaluating the following:
    • Best response to therapy (CR, PR, SD, PD) will be summarized by
    treatment arm. In addition, the number (%) of patients with an overall
    response (CR or PR) and with disease control (PR or CR or SD) will be
    reported. Duration of responses will also be summarized.
    • Progression-free survival time (PFS) will be summarized by treatment
    arm. PFS is defined as the time from randomization to the date of
    disease progression or death, whichever occurs first, before or after
    treatment discontinuation. For those still on study and those who remain
    alive and have not progressed after treatment discontinuation, PFS will
    be censored on the date of the last tumor assessment.
    • Serum Hsp27 levels, serum clusterin levels and CTC counts will be
    summarized by treatment arm.
    • Serum OGX-427 Cmax and trough levels will be summarized by
    treatment arm.
    Gli end-point secondari di efficacia comprendono le seguenti valutazioni:
    • Miglior risposta alla terapia (CR, PR, SD, PD) riassunta per braccio di trattamento. Inoltre, verrà segnalato il numero (%) dei pazienti con una risposta globale (CR o PR) e con controllo della malattie (PR o CR o SD). Verranno presentate il numero delle risposte.
    • Progressione - sopravvivenza libera da progressione (PFS) verranno sintetizzate per braccio di trattamento. PFS è definito come il tempo dalla randomizzazione alla data di progressione della malattia o la morte, a seconda di quale si verifichi per prima, prima o dopo interruzione del trattamento. Per coloro ancora in studio e coloro che sopravvivono e non hanno progredito dopo interruzione del trattamento, PFS sarà considerata la data dell'ultima valutazione del tumore.
    • I livelli sierici di hsp27, i livelli sierici di clusterina e conta CTC sarà sintetizzati per braccio di trattamento.
    • Livelli sierici di OGX-427 Cmax e attraverso gli altri livelli verranno sintetizzati per braccio di trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time from the date of randomization to the date of death from any cause
    or the date of last contact for alive patients.
    Tempo dalla data di randomizzazione alla data di morte per qualsiasi causa
    o alla data dell'ultimo contatto per i pazienti in vita.
    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 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 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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Canada
    United States
    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
    LVLS
    LVLS
    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 months30
    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 months30
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 180
    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)
    All the patients will receive the local standard of care for their condition after their participation in the trial
    Dopo la loro partecipazione al trial, tutti i pazienti riceveranno lo standard locale di cura per la loro condizione
    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 Decision2012-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-12
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