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    Summary
    EudraCT Number:2016-002552-24
    Sponsor's Protocol Code Number:PKAPIR
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-05
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-002552-24
    A.3Full title of the trial
    Pemetrexed (Alimta®) in maintenance in patients with impaired renal function: multicenter randomized Phase 4 study comparing two strategies for dose calculation
    Pemetrexed (Alimta®) en maintenance chez les patients avec une fonction rénale altérée : étude multicentrique de phase 4 randomisée comparant 2 stratégies de calcul de dose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pemetrexed (Alimta®) in maintenance in patients with impaired renal function: multicenter randomized Phase 4 study comparing two strategies for dose calculation
    Pemetrexed (Alimta®) en maintenance chez les patients avec une fonction rénale altérée : étude multicentrique de phase 4 randomisée comparant 2 stratégies de calcul de dose
    A.3.2Name or abbreviated title of the trial where available
    PKAPIR
    PKAPIR
    A.4.1Sponsor's protocol code numberPKAPIR
    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 SponsorCentre Georges François Leclerc
    B.1.3.4CountryFrance
    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 supportCentre Georges François Leclerc
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Georges François Leclerc
    B.5.2Functional name of contact pointRederstorff
    B.5.3 Address:
    B.5.3.1Street Address21 rue du Pr Marion
    B.5.3.2Town/ cityDIJON
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)380 76 75 003461
    B.5.5Fax number+33(0)380 73 77 53
    B.5.6E-mailERederstorff@cgfl.fr
    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 ALIMTA
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Netherland B.V
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameALIMTA
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Patients with non-small lung cell cancer
    Patients avec un cancer bronchique non à petites cellules à prédominance non épidermoïde
    E.1.1.1Medical condition in easily understood language
    Patients with non-small lung cell cancer
    Patients avec un cancer bronchique non à petites cellules à prédominance non épidermoïde
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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 assess the impact of calculating the dose of pemetrexed administered according to the creatinine clearance by Cockcroft-Gault (CrCLCG) versus depending on body surface area (BSA) on the median time to treatment discontinuation for renal function ≤ 45mL / min in patients treated for non-small lung cell cancer predominantly non-squamous in maintenance situation
    Evaluer l’impact du calcul de la dose de pemetrexed à administrer en fonction de la clairance de la créatine selon Cockcroft-Gault (CrCLCG) versus en fonction de la surface corporelle (SC) sur le temps médian avant arrêt du traitement pour fonction rénale ≤ 45mL/min chez des patients en traités pour un cancer du poumon non à petites cellules à prédominance non épidermoïde en situation de maintenance
    E.2.2Secondary objectives of the trial
    To assess the impact of calculating the dose of pemetrexed administered according to the CrCLCG versus according to the SC on the time to treatment discontinuation, progression-free survival (PFS) and overall survival (OS) of patients
    Evaluer l’impact du calcul de la dose de pemetrexed à administrer en fonction de la CrCLCG versus en fonction de la SC sur le temps jusqu’à arrêt du traitement, la survie sans progression (SSP) et la survie globale (SG) des patientes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patient over 18 years
    •patient with a non-small cell lung cancer predominantly non-squamous histologically documented
    •Patient planned to start a treatment or ongoing maintenance treatment with pemetrexed
    •Neutrophils> 1500 / mm3; platelets> 100,000 / mm3
    •Written informed consent signed and dated
    •For patients of childbearing age, effective contraception
    •Creatinine clearance according to Cockcroft-Gault formula between 70 and 45 mL / min
    •PS=0 or 1
    •Patient de plus de 18 ans
    •Patient porteur d’un cancer du poumon non à petites cellules à prédominance non épidermoïde documenté histologiquement
    •Patient devant débuter un traitement ou en cours de traitement de maintenance par pemetrexed
    •Neutrophiles > 1 500 /mm3 ; plaquettes > 100 000 /mm3
    •Consentement éclairé, écrit daté et signé
    •Pour les patientes en âge de procréer, moyen efficace de contraception
    •Clairance de la créatinine selon la formule de Cockcroft-Gault comprise entre 70 et 45 mL/min
    •PS=0 ou 1
    E.4Principal exclusion criteria
    •Patient contraindicated with pemetrexed treatment
    •Patient with symptomatic brain metastases
    •Pregnant or nursing women
    •Patient under guardianship or submitted to major people protection regime
    •Patient not affiliated with a social security scheme (beneficiary or beneficiary)
    •Patient présentant une contre-indication au traitement par pemetrexed
    •Patient présentant des métastases cérébrales symptomatiques
    •Femmes enceintes ou allaitant
    •Patient sous tutelle ou curatelle ou soumise à un régime de protection des personnes majeures
    •Patient non affilié à un régime de sécurité sociale (bénéficiaire ou ayant droit)
    E.5 End points
    E.5.1Primary end point(s)
    The median time to treatment discontinuation for renal function ≤ 45 mL / min (Cockcroft-Gault) is defined as the time interval between the date of randomization to treatment discontinuation date due to a creatinine clearance ≤ 45 mL / min. Treatment stops for other reasons than a too low clearance will be censored.
    Le temps médian avant arrêt du traitement pour fonction rénale ≤ 45mL/min (Cockcroft-Gault) est défini comme l’intervalle de temps entre la date de randomisation et la date d’arrêt de traitement dû à une clairance de la créatinine ≤ 45mL/min. Les arrêts de traitement pour d’autres motifs qu’une clairance trop basse seront censurés.
    E.5.1.1Timepoint(s) of evaluation of this end point
    when treatment is stopped
    arrêt du traitement
    E.5.2Secondary end point(s)
    The median time to therapy discontinuation is defined as the time interval between the date of randomization and the stop date regardless of the cause.
    Le temps médian avant arrêt du traitement est défini comme l’intervalle de temps entre la date de randomisation et la date d’arrêt de traitement quelle que soit la cause.
    La survie sans progression est définie comme l’intervalle de temps entre la date de randomisation et la date de décès quelle qu’en soit la cause ou la date de progression, en prenant en compte l’évènement survenant en premier.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression-free survival is defined as the time interval between the date of randomization and the date of death from any cause or date of increase, taking into account the event occurs first.
    The progress will be assessed according to RECIST criteria. Progression-free survival is defined as the time interval between the date of randomization and the date of death.
    La progression sera évaluée selon les critères RECIST. La survie sans progression est définie comme l’intervalle de temps entre la date de randomisation et la date de décès.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months45
    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 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.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state124
    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)
    none
    aucun
    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 Decision2016-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-07
    P. End of Trial
    P.End of Trial StatusOngoing
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