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    Summary
    EudraCT Number:2013-003866-15
    Sponsor's Protocol Code Number:ABI-007-PANC-CA046C
    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:2013-12-12
    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 number2013-003866-15
    A.3Full title of the trial
    MPACT EXTENSION STUDY: MULTICENTER, SURVIVAL DATA COLLECTION IN SUBJECTS PREVIOUSLY ENROLLED IN PROTOCOL CA046
    Studio di estensione MPACT: Multicentrico, di raccolta dei dati sulla sopravvivenza in soggetti precedentemente arruolati nel protocollo CA046
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MPACT EXTENSION STUDY: MULTICENTER, SURVIVAL DATA COLLECTION IN SUBJECTS PREVIOUSLY ENROLLED IN PROTOCOL CA046
    Studio di raccolta dei dati sulla sopravvivenza in soggetti precedentemente arruolati nel protocollo CA046
    A.4.1Sponsor's protocol code numberABI-007-PANC-CA046C
    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 SponsorCelgene Corporation
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1888-260-1599
    B.5.5Fax number+1913-266-0394
    B.5.6E-mailClinicalTrialDisclosure@celgene.com
    D. IMP Identification
    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
    Metastatic Adenocarcinoma of the Pancreas
    Adenocarcinoma pancreatico metastatico
    E.1.1.1Medical condition in easily understood language
    Pancreatic cancer that has spread to other organs
    Tumore del pancreas disseminato ad altri organi
    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 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    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
    The primary objective of the study is to collect survival/vital status of CA046 subjects who were known to be alive at the last report of vital status for CA046
    Raccogliere lo stato vitale/di sopravvivenza dei soggetti CA046 che risultavano essere vivi all’ultimo report dello stato vitale per CA046.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to collect date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046.
    Raccogliere la data di progressione della malattia e della conseguente terapia anticancro per l’adenocarcinoma pancreatico diversa da quella già registrata per il soggetto mentre era arruolato in CA046.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must have been enrolled in the CA046 study.
    2. Must have been living at the time of the last survival follow-up (approximate timeframe – end of March, 2013)
    3. Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (ie, next of kin, legal representative) will be obtained prior to collection of data).
    1. Devono essere stati arruolati nello studio CA046.
    2. Devono essere in vita al momento dell’ultimo follow-up di sopravvivenza (periodo approssimativo – fine Marzo 2013)
    3. Devono comprendere ed essere in grado di fornire il consenso informato (se un soggetto è deceduto, il consenso legale appropriato (ovvero un prossimo, rappresentante legale) sarà ottenuto prima della raccolta dei dati).
    E.4Principal exclusion criteria
    4. Consent refused for any reason.
    1. Consenso negato per qualunque ragione
    E.5 End points
    E.5.1Primary end point(s)
    Vital status / overall survival for CA046 subjects who were known to be alive at the last report of vital status for CA046
    Stato vitale/di sopravvivenza dei soggetti CA046 che risultavano essere vivi all’ultimo report dello stato vitale per CA046.
    E.5.1.1Timepoint(s) of evaluation of this end point
    approximate timeframe – end of March, 2013.
    Periodo di tempo approssimativo fine Marzo 2013
    E.5.2Secondary end point(s)
    Date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046.
    Data di progressione della malattia e della conseguente terapia anticancro per l’adenocarcinoma pancreatico diversa da quella già registrata per il soggetto mentre era arruolato in CA046
    E.5.2.1Timepoint(s) of evaluation of this end point
    Enrollment in CA046
    Arruolamento in CA046
    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 No
    E.6.4Safety No
    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
    Extension study
    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) No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Australia
    Canada
    Ukraine
    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 End of Trial is defined as either the date of the last visit of the last subject to complete the study, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre-specified in the protocol and/or the Statistical Analysis Plan, whichever is the later date.This study will end when all enrolled subjects reach 3 year survival,have died,have been lost to follow-up,or have withdrawn consent, whichever comes first.
    Fine Studio è data ultima visita ultimo soggetto per completare lo studio,o data di ricezione ultimo dato ultimo paziente necessario per analisi primaria,secondaria o esplorativa,come anticipatamente specificato nel protocollo e/o nel piano di analisi statistica,a seconda ciò che si verifica per ultimo.Questo studio finirà quando tutti i pazienti arruolati hanno i 3anni di sopravvivenza, sono deceduti, sono stati stati persi al follow-up,hanno ritirato consenso,secondo ciò che si verifica prima.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19
    F.4.2.2In the whole clinical trial 70
    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
    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 Decision2014-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
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