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    Summary
    EudraCT Number:2010-022560-12
    Sponsor's Protocol Code Number:IMCLCP15-1008
    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:2012-03-01
    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 number2010-022560-12
    A.3Full title of the trial
    A Phase 2 Study of a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in Previously Treated Patients with Unresectable and/or Metastatic Gastrointestinal Stromal Tumors (GIST)
    Studio di fase 2 su un Anticorpo Monoclonale Umano anti-PDGFRα (IMC-3G3) in Pazienti gia' Sottoposti a Trattamento per Tumore Stromale Gastrointestinale (GIST) non Resecabile e/o Metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of IMC-3G3 in patients with inoperable or outspread Tumors of the Gastrointestinal Stroma, already having been treated with standard treatments.
    Uno studio su IMC-3G3 in pazienti con Tumore dello Stroma Gastrointestinale non operabile o esteso, che sono gia' stati trattati con trattamenti standard.
    A.4.1Sponsor's protocol code numberIMCLCP15-1008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01316263
    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 SponsorIMCLONE LLC
    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 supportmClone Systems Corporation, a wholly-owned subsidiary of Eli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImClone Systems International
    B.5.2Functional name of contact pointClinical Trials Info
    B.5.3 Address:
    B.5.3.1Street AddressAm Taubenfeld 21/2
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69123
    B.5.3.4CountryGermany
    B.5.4Telephone number0049 6221 7050 9888
    B.5.5Fax number0049 6221 7050 9889
    B.5.6E-mailClinicalTrials@imclone.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 nameIMC-3G3
    D.3.2Product code IMC-3G3
    D.3.4Pharmaceutical form Solution for injection
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeIMC-3G3
    D.3.9.3Other descriptive nameanticorpo monoclinale umano ricombinante, che ha come target PDGFRa
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 typeanticorpo monoclonale
    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
    Gastrointestinal Stromal Tumors (GIST)
    Tumore Stromale Gastrointestinale (GIST)
    E.1.1.1Medical condition in easily understood language
    Cancer of the connective tissue of the digestive tract
    Cancro del tessuto connettivo del tratto digestivo
    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 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the tumor response of stable disease (SD) or better at 12 weeks in two separate cohorts representing molecularly distinct subsets of previously treated patients with GIST when treated with IMC-3G3: Cohort 1 includes patients with GIST harboring PDGFRα mutations (D842V and any others), while Cohort 2 includes patients with GIST not harboring PDGFRα mutations.
    L’obiettivo primario è valutare la risposta tumorale della malattia stabile (SD) o in miglioramento a 12 settimane in due coorti separate che rappresentano sottoinsiemi distinti da un punto di vista molecolare, di pazienti affetti da GIST già trattati in precedenza, quando trattati con IMC-3G3: La coorte 1 include pazienti affetti da GIST che presentano mutazioni del PDGFRα (D842V ed altri), mentre la coorte 2 include pazienti affetti da GIST che non presentano mutazioni del PDGFRα.
    E.2.2Secondary objectives of the trial
    To evaluate the progression-free survival; • To evaluate the safety profile of IMC-3G3 in patients with GIST; • To evaluate the radiographic objective response rate (ORR) and disease control rate (DCR) determined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1); • To evaluate the OS; and • To evaluate the PK profile and immunogenicity of IMC-3G3. • Lo stato delle prestazioni Eastern Cooperative Oncology Group (ECOG) del paziente è compreso tra 0 e 2 •
    • Valutare la sopravvivenza senza progressione • Valutare il profilo di sicurezza dell’IMC-3G3 in pazienti affetti da GIST • Valutare il tasso obiettivo di risposta radiografica (ORR) e il tasso di controllo della patologia (DCR) determinati dai Criteri di valutazione della risposta nei tumori solidi, versione 1.1 (RECIST 1.1) • valutare la sopravvivenza globale (OS) • valutare il profilo PK e l’immunogenicità dell’IMC 3G3
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient has histologically or cytologically confirmed, unresectable and/or metastatic GIST. ● Patient has measurable disease. ● Patient has objective progression following, or intolerance to, treatment with both imatinib and sunitinib. ● Patient's Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2. ● Patient has either: 1. prior results from KIT and PDGFRα mutation analysis that meet analytical criteria as defined for the on-study analysis of these mutations and tumor tissue (from either primary or metastatic tumor)that can be submitted for analysis within 30 days after the first dose of study therapy; or 2. if prior results from KIT and PDGFRα mutation analysis are not available or do not meet analytical criteria as above, then tumor tissue (from either primary or metastatic tumor) must be submitted for genotype testing at the latest 28 days prior to the first dose of study therapy. ● Patient has adequate hematologic, hepatic, renal and coagulation function. ● Women of childbearing potential and sexually active males must agree to use adequate contraception prior to study and for the duration of study participation. ● Patient has a life expectancy of ≥ 3 months.
    ●Il paziente è affetto da GIST confermato istologicamente o citologicamente, non resecabile e/o metastatico. ●Il paziente è affetto da una patologia misurabile ● Il paziente presenta una progressione obiettiva, o intolleranza, dopo il trattamento con almeno imatinib e sunitinib. ● Il paziente presenta: 1. Risultati precedenti all’analisi di mutazione KIT e PDGFRα che soddisfano i criteri analitici come definito per l’analisi di studio di tali mutazioni e tessuto tumorale (di tumore primario o metastatico) che può essere inviato per le analisi entro 30 giorni dalla prima dose della terapia di studio; o b. Se non sono disponibili risultati precedenti alle analisi di mutazione KIT e PDGFRα o non soddisfano i criteri analitici come indicato precedentemente, è necessario inviare il tessuto tumorale (di tumore primario o metastatico) per il test per la genotipizzazione almeno 28 giorni prima della prima dose della terapia di studio. ● Il paziente presenta una funzione ematologiva, epatica, renale e di coaugulazione adeguata. ●le donne in età fertile (WOCBP) e soggetti maschi sessualmente attivi devono accettare di utilizzare metodi contraccettivi adeguati prima dell’inserimento nello studio e per tutta la durata della partecipazione allo studio ● Il paziente ha un’aspettativa di vita di ≥ 3 mesi.
    E.4Principal exclusion criteria
    Patient has untreated central nervous system metastases, and as a result, is clinically unstable with regard to neurologic function. ● Patient has a history of another primary cancer. ● Patient is currently enrolled in a clinical trial involving an investigational product. ● Patient is receiving concurrent treatment with other anticancer therapy. ● Patient has known immunodeficiency virus (HIV) infection. ● Patient has undergone major surgery within 28 days prior to registration. ● If female, patient is pregnant or breastfeeding.
    ● Il paziente presenta metastasi al sistema nervoso centrale non trattate e di conseguenza è clinicamente instabile relativamente alla funzione neurologica ● Il paziente ha un’anamnesi di un altro cancro primario ● Il paziente è attualmente arruolato, in una sperimentazione clinica che coinvolge un prodotto sperimentale ● Il paziente sta ricevendo un trattamento concomitante con altre terapie anti-cancro ● Il paziente è infetto da virus da immunodeficienza umana (HIV). ● Il paziente è stato sottoposto a intervento principale nel corso dei 28 prima della registrazione. ● Se di sesso femminile, in stato di gravidanza o allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is tumor response rate of SD or better at 12 weeks. The tumor response rate of SD or better at 12 weeks is defined as the proportion of patients with a response of SD or better, as defined by RECIST 1.1, at 12 weeks following the first dose of study therapy. Patients will be considered ''failure'' if they die or if radiographic evaluation indicates a response of PD at 12 weeks or before. The tumor response rate of SD or better at 12 weeks and its 90% confidence limit will be estimated.
    La variabile di efficacia primaria è la risposta tumorale della malattia stabile (SD) o in miglioramento a 12 settimane. Il grado di risposta tumorale della SD o in miglioramento, come definito dal RECIST 1.1, a 12 settimane dopo la prima dose di farmaco in studio. I pazienti saranno considerati ''failure'' se essi muoiono o se la valutazione radiologica indica un a risposta di PD a 12 settimane o prima. Sarà valutato il grado di risposta tumorale della SD o in miglioramento a 12 settimane e il suo intervallo di confidenza al 90%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks following the first dose of study therapy
    12 settimane dopo la prima dose della terapia in studio.
    E.5.2Secondary end point(s)
    Secondary Efficacy endpoints include PFS, OS and ORR. PFS is defined as the time from first dose of study therapy until the first radiographic documentation of disease progression per RECIST 1.1, or death from any cause.Overall survival is defined as the time from the date of first dose of study therapy to the date of death from any cause. The ORR is equal to the proportion of patients achieving a best overall response of partial or complete response (PR + CR), according to RECIST 1.1
    Gli endopints di Efficacia Secondari includono PFS, OS e ORR. PFS è definita come il tempo dalla prima dose di farmaco fino alla prima radiografia documentante la progressione della malattia per RECIST 1.1 o morte per qualsiasi causa. La sopravvivenza globale è definita come il tempo dalla data della prima dose di terapia in studio fino alla data della morte per qualsiasi causa. L’ORR è uguale alla proporzione di pazienti che ottengono una risposta globale migliore della risposta parziale o completa (PR + CR), in base alle RECIST 1.1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not definable
    Non definibile
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity Assessments
    Valutazioni di Immunogenicità
    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 Information not present in EudraCT
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    The study will be considered closed when all patients have progressed, died, or completed study therapy and been followed for at least 30 days from last dose. In addition, before the study will be considered closed, the investigator remains responsible for following, through an appropriate health care option, AEs that are serious or that caused the patient to discontinue before completing the study. The patient should be followed until the event is resolved or explained.
    lo studio sarà considerato chiuso quando tutti i pazienti avranno avuto progressione, morte o completato la terapia in studio e siano stati seguiti per almeno 30 giorni dopo l'ultima dose.
    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 months17
    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 months17
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 72
    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)
    After discontinuation of study therapy, further treatment is done based on the decision of the investigator. Follow-up information on additional anticancer treatment, disease progression (for patients who discontinued for reasons other than progressive disease [PD]), and survival will be collected every 2 months (± 7 days) for a minimum of 1 year following discontinuation of study therapy
    Dopo la sospensione della terapia in studio, ulteriore trattamento si basa sulla decisione dello sperimentatore. Informazioni di follow up su trattamenti anti-tumorali aggiuntivi, progressione della malattia (per pazienti che hanno sospeso il farmaco per motivi diversi rispetto alla progressione (PD)) e sopravvivenza, saranno raccolti ogni 2 mesi (± 7 days) per un minimo di 1 anno dopo la sospensione della terapia in studio.
    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 Decision2011-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-13
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