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    Summary
    EudraCT Number:2008-007799-13
    Sponsor's Protocol Code Number:48226787
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-26
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2008-007799-13
    A.3Full title of the trial
    Panitumumab (Vectibix®) og liposomal doxorubicin (Caelyx®) til platinresistent
    epithelial ovariecancer uden KRAS mutationer
    A.4.1Sponsor's protocol code number48226787
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVejle Sygehus
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Vectibix
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Information not present in EudraCT
    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 INNPanitumumab
    D.3.9.1CAS number 339177-26-3
    D.3.9.3Other descriptive nameAntineoplastic
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeCytostatikum. Monoklonalt antineoplastisk antistof produceret ved rekombinant DNA teknik
    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 Yes
    D.2.1.1.1Trade name Caelyx
    D.2.1.1.2Name of the Marketing Authorisation holderSP Europe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCaelyx
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDoxorubicin
    D.3.9.1CAS number 23214-92-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeTopoisomerasehæmmer. Antracyclinderivat.
    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
    Platinresistent epithelial ovariecancer uden KRAS mutationer.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    At belyse reponsraten hos patienter med platinresistent ovariecancer uden KRAS mutation (KRAS wildtype), når de behandles med liposomal doxorubicin suppleret med biologisk behandling i form af panitumumab.
    E.2.2Secondary objectives of the trial
    At belyse progressionsfri overlevelse (PFS) og overall survival (OS) hos patienter med ovariecancer, når de behandles med liposomal doxorubicin og panitumumab.
    Yderligere ønskes klinisk sikkerhed og toksicitet belyst.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologisk verificeret epithelial primær ovarie-, tuba- eller peritoneal cancer, stadium I-IV.

    A: 1. linie behandling med et platinregime med enten progression eller manglende respons efter 1. linie kemoterapi, eller recidiv inden for 6 måneder efter 1. linie kemoterapi.

    eller

    B: 2. linie behandling med et platinindeholdende regime med enten progression eller manglende respons under 2. linie kemoterapi, eller recidiv inden for 6 måneder efter afslutning af 2. linie kemoterapi.

    • Max. to tidligere linjer kemoterapi (begge platinbaseret).
    • Alder ≥ 18 år.
    • Performance status 0-2.
    • Målbar sygdom iht. CA125 GCIG kriterier
    • KRAS wild type (KRAS uden mutationer)
    • Tilstrækkelig funktion af knoglemarv, lever, nyrer og koagulationsparametre (inden for 7 dage før inklusion):
    - Leukocytter ≥ 3.0 x 109/l, neutrofilocytter (ANC) ≥ 1.5 x 109/l
    - Thrombocytter ≥ 100 x 109/l
    - Hæmoglobin ≥ 9.7 g/dl (6 mmol/L)
    - Serum bilirubin ≥ 1.5 x UNL
    - Serum transaminases ≤ 2.5 x UNL uden levermetastaser, el. ≤ 5 x UNL med levermetastaser
    - Serum creatinin ≤ 1.5 x UNL
    - Magnesium ≥ nedre normalgrænse
    - Calcium ≥ nedre normalgrænse
    • Fertile kvinder skal have negativ graviditetstest og anvende sikker antikonception under og 6 måneder efter behandlingen. Følgende metoder anses for sikker antikonception: P-piller, spiral, depotinjektion af gestagen, subdermal implantation, hormonal vaginalring samt transdermal depotplaster.
    • Accept af, at blod og vævsprøver gemmes til senere undersøgelse af biomarkører
    • Skriftligt og mundtligt informeret samtykke
    E.4Principal exclusion criteria
    • Tidligere behandling med kemoterapi eller biologisk targeteret behandling, undtaget 1. og 2. linie kemoterapi med platin alene eller i kombination med taxan (bevacizumab tilladt som del af 1. linie behandling).
    • Tidligere eller planlagt behandling med anden forsøgs¬medicin, eller deltagelse i et andet klinisk forsøg inden for 28 dage før inklusion i dette forsøg.
    • Gravide eller ammende kvinder, og kvinder, der planlægger at blive gravide inden for 6 måneder efter endt behandling.
    • Anden nuværende eller tidligere malign sygdom undtaget kurativt behandlet cervix cancer, non-melanom hudcancer eller anden cancer med minimal risiko for recidiv.
    • CNS metastaser
    • Tidligere kronisk medicinsk eller psykiatrisk lidelse, eller anormale laboratorium værdier, som ikke kontrolleres medicinsk eller som investigator vurderer, kan øge risici ifm. administration af forsøgsmedicinen (f.eks. diabetes, hjertesygdom, hypertension).
    • Klinisk signifikant hjerte/karsygdom ≤ 1 år før inklusion i undersøgelsen, herunder:
    - Hjerteinfarkt eller angina pectoris inden for 6 måneder før inklusion i undersøgelsen
    - New York Heart Association (NYHA) ≥ Grad 2 congestive heart failure. På trods af medicinering herfor.
    - Ringe kontrolleret kardiel arytmi trods medicinering (patienter med velreguleret atrie flimren kan inkluderes)
    • Ukontrolleret hypercalcemia (calcium niveau > øvre normal¬grænse; calcium sænkende behandling er tilladt).
    • Overfølsomhed over for det aktive stof, et eller flere af hjælpestofferne eller Staphylococcus Protein A.
    • Patienter med interstitiel pneumonitis eller pulmonal fibrose eller interstitiel lungesygdom påviselig ved baseline CT scanning af thorax.
    E.5 End points
    E.5.1Primary end point(s)
    Responsrater (baseret på GCIG modificerede CA-125 kriterier (30;31))
    RECIST kriterier vil ikke blive anvendt i denne protokol.
    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 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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open No
    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.8.3 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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 state33
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 33
    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 Decision2009-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-30
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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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