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    Summary
    EudraCT Number:2015-001922-40
    Sponsor's Protocol Code Number:CLDK378A2X01B
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-001922-40
    A.3Full title of the trial
    An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored
    ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib.
    Studio in aperto, multicentrico, di Fase IV, roll-over in pazienti con tumori ALK positivi che hanno completato uno studio precedente con ceritinib (LDK378), sponsorizzato da Novartis, e che secondo il giudizio dello sperimentatore presentano beneficio dal trattamento continuativo con ceritinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to allow patients with ALK+ malignancies to continue ceritinib treatment
    Studio per consentire ai pazienti con tumori ALK+ di continuare il trattamento con ceritinib.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCLDK378A2X01B
    A.5.4Other Identifiers
    Name:NANumber:CLDK378A2X01B
    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 SponsorNOVARTIS FARMA S.P.A.
    B.1.3.4CountryItaly
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma S.p.A.
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21010
    B.5.3.4CountryItaly
    B.5.4Telephone number03390296541
    B.5.5Fax number0339029659066
    B.5.6E-mailinfo.studiclinici@novartis.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 nameNA
    D.3.2Product code LDK378
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNceritinib
    D.3.9.1CAS number 1032900-25-6
    D.3.9.2Current sponsor codeLDK378
    D.3.9.4EV Substance CodeSUB130802
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    Non small cell lung cancer
    Tumore del polmone non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    Tumore del polmone
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 evaluate long term safety data (SAEs and AEs)
    Valutare i dati di sicurezza d¿impiego a lungo termine (eventi avversi seri ed eventi avversi)
    E.2.2Secondary objectives of the trial
    To evaluate clinical benefit as assessed by the investigator.
    Valutare il beneficio clinico, determinato dallo sperimentatore
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.
    - Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
    - Wilingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
    - Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

    Other protocol defined inclusion criteria may apply.
    - Pazienti che stanno attualmente ricevendo il trattamento con ceritinib in uno studio sponsorizzato da Novartis che ha soddisfatto i requisiti dell’obiettivo primario e che, secondo l’opinione dello sperimentatore, potrebbero manifestare beneficio dal trattamento continuativo.
    - Pazienti che hanno dimostrato compliance, valutata dallo sperimentatore, ai requisiti del protocollo dello studio di appartenenza.
    - I pazienti devono essere disposti e capaci di aderire alle visite programmate, ai piani di trattamento e alle altre procedure dello studio.
    - Consenso informato scritto ottenuto prima dell’arruolamento nello studio roll-over e prima di ricevere il farmaco in studio. Qualora il consenso del paziente non potesse essere espresso per iscritto, ciò dovrà essere formalmente documentato e testimoniato da un testimone imparziale.

    Ulteriori altri criteri sono riportati all'interno del protocollo.
    E.4Principal exclusion criteria
    1. Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason.
    2. Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study. (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ceritinib dosing to resume.)
    3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test.
    4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after stopping ceritinib treatment.
    5. Sexually active males unless they use a condom during intercourse while taking drug and
    for 3 months after stopping ceritinib and should not father a child for at least 3 months
    after the last dose of treatment. A condom is required to be used also by vasectomized
    men as well as during intercourse with a male partner in order to prevent delivery of the
    drug via seminal fluid.
    - Pazienti che hanno sospeso definitivamente e anticipatamente il trattamento con ceritinib nello studio di appartenenza per qualsiasi motivo.
    - Pazienti che presentano al momento tossicità non risolte a causa delle quali è stata interrotta la somministrazione di ceritinib nello studio di appartenenza. (I pazienti che soddisfano tutti gli altri criteri di eleggibilità potranno essere arruolati una volta risolte le tossicità, così da consentire la ripresa della somministrazione di ceritinib).
    - Donne in gravidanza o in allattamento. La gravidanza viene definita dallo stato successivo al concepimento e fino al termine della gestazione, confermato da un test per l’hCG nel siero positivo.
    - Donne potenzialmente fertili, definite come tutte le donne che fisiologicamente possono concepire, a meno che non utilizzino un metodo contraccettivo efficace durante lo studio e per 3 mesi dopo la sospensione del trattamento con ceritinib.
    - Pazienti maschi sessualmente attivi, a meno che non utilizzino un preservativo durante i rapporti sessuali mentre stanno assumendo il trattamento e per 3 mesi dopo la somministrazione dell’ultima dose del trattamento in studio. Anche i pazienti vasectomizzati, così come durante un rapporto sessuale con un partner maschile, devono utilizzare un preservativo per prevenire il passaggio del farmaco nel liquido seminale.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
    frequenza e gravità degli eventi avversi e degli eventi avversi seri.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The assessment of safety will be based on the frequency of adverse events (AEs) and serious adverse events (SAEs)
    Le valutazioni di sicurezza si baseranno sulla frequenza degli eventi avversi
    (AE) e degli eventi avversi seri (SAE).
    E.5.2Secondary end point(s)
    Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.
    La percentuale di pazienti con beneficio clinico, valutato dallo sperimentatore, in occasione delle visite programmate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At every quarterly visit
    Ad ogni visita trimestrale
    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 Yes
    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 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 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 trial1
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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 Information not present in EudraCT
    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
    Hong Kong
    Japan
    Russian Federation
    Singapore
    Taiwan
    Thailand
    United States
    Belgium
    France
    Germany
    Italy
    Netherlands
    Norway
    Spain
    United Kingdom
    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 the study will occur after all patients in the study have completed their last assessment per protocol. The last assessment for each patient is the safety follow-up visit that occurs 30 days after the patient's last dose of study treatment or until SAE follow up is resolved as required, whichever is later.
    La conclusione della sperimetazione avverrà quando tutti i pazienti dello studio avranno completato l'ultima visita da protocollo. L'ultima visita per ogni paziente consiste nella visita di sicurezza di follow-up e si verifica 30 giorni dopo l'ultima assunzione dell'ultima dose di farmaco da parte del paziente o finch¿ la visita di SAE follow-up non si ¿ conclusa, come richiesto,
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months4
    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.1.1.1In 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: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 150
    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)
    NA
    NA
    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 Decision2015-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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