Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-002894-39
    Sponsor's Protocol Code Number:8273-CL-0302
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-02-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-002894-39
    A.3Full title of the trial
    An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations
    Étude de phase III randomisée menée en ouvert dans le but de comparer l’efficacité de l’ASP8273 à celle de l’erlotinib ou du géfitinib en traitement de première ligne chez des patients atteints de cancer bronchique non à petites cellules de stade IIIB/IV avec mutations activatrices de l’EGFR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations (SOLAR Study)
    Étude de phase III randomisée menée en ouvert dans le but de comparer l’efficacité de l’ASP8273 à celle de l’erlotinib ou du géfitinib en traitement de première ligne chez des patients atteints de cancer bronchique non à petites cellules de stade IIIB/IV avec mutations activatrices de l’EGFR (Étude SOLAR)
    A.3.2Name or abbreviated title of the trial where available
    SOLAR
    A.4.1Sponsor's protocol code number8273-CL-0302
    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 SponsorAstellas Pharma Global Development, Inc.
    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 supportAstellas Pharma Inc,
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma BV
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62, PO Box 64
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2300 AH
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715455912
    B.5.5Fax number+31715455840
    B.5.6E-mailTanja.Megens-deLange@astellas.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 nameASP8273
    D.3.2Product code ASP8273
    D.3.4Pharmaceutical form Capsule
    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 INNnot available
    D.3.9.2Current sponsor codeASP8273
    D.3.9.3Other descriptive nameASP8273 mesilate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Iressa
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca AB
    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 Film-coated tablet
    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 INNGefitinib
    D.3.9.1CAS number 184475-35-2
    D.3.9.3Other descriptive nameGEFITINIB
    D.3.9.4EV Substance CodeSUB20637
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma US
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameerlotinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNERLOTINIB
    D.3.9.1CAS number 183321-74-6
    D.3.9.4EV Substance CodeSUB16423MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma US
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameerlotinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNERLOTINIB
    D.3.9.1CAS number 183321-74-6
    D.3.9.4EV Substance CodeSUB16423MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma US
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameerlotinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNERLOTINIB
    D.3.9.1CAS number 183321-74-6
    D.3.9.4EV Substance CodeSUB16423MIG
    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 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
    Non-small Cell Lung Cancer Tumors
    Cancer bronchique non à petites cellules
    E.1.1.1Medical condition in easily understood language
    Non-small Cell Lung Cancer Tumors
    Cancer bronchique non à petites cellules
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 100000004864
    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 the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.
    Comparer la survie sans progression (SSP) de la maladie, sur la base d’un examen radiologique indépendant (ERI), entre des patients traités par ASP8273 ou par erlotinib ou géfitinib présentant un cancer bronchique non à petites cellules (CBNPC) de type adénocarcinome localement avancé, métastatique ou inopérable de stade IIIB/IV avec mutations activatrices du récepteur du facteur de croissance épidermique (EGFR)
    E.2.2Secondary objectives of the trial
    - Overall survival (OS)
    - Overall response rate (ORR) as assessed by IRR
    - PFS as assessed by the investigator
    - Disease control rate (DCR) as assessed by IRR
    - Safety of ASP8273
    Survie globale (SG)
    Taux de réponse globale (TRG) évalué par examen radiologique indépendant (ERI)
    SSP évaluée par l’investigateur
    Taux de contrôle de la maladie (TCM) évalué par ERI
    Sécurité d’emploi de l’ASP8273
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Retrospective PGx Substudy
    Sous-étude pharmacogénomique rétrospective
    E.3Principal inclusion criteria
    Subject must meet all of the following inclusion criteria to be eligible for participation in this study at enrollment:
    1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures.
    2. Subject is ≥ 18 years of age and legally an adult according to local regulation at the time of signing informed consent.
    3. Subject agrees not to participate in another interventional study while on treatment.
    4. Female subject must either:
    Be of nonchildbearing potential:
    - postmenopausal (defined as at least 1 year without any menses) prior to Screening, or
    - documented surgically sterile
    Or, if of childbearing potential:
    - Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
    - And have a negative serum pregnancy test at Screening
    - And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control* (at least 1 of which must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration
    5. Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.
    6. Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
    7. Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control* (1 of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after the final study drug administration.
    *Highly effective forms of birth control include:
    - Consistent and correct usage of established oral, injected or implanted hormonal methods of contraception
    - Established intrauterine device (IUD) or intrauterine system (IUS)
    - Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
    8. Male subject must not donate sperm starting at Screening and throughout the study period and for 90 days after the final study drug administration.
    9. Subject has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
    10. Subject has histologically confirmed locally advanced, metastatic or unresectable Stage IIIB/IV adenocarcinoma NSCLC (newly diagnosed or recurrent). Subjects with mixed histology are eligible if adenocarcinoma is the predominant histology.
    11. Subject has predicted life expectancy ≥ 12 weeks in the opinion of the investigator.
    12. Subject must meet all of the following criteria on the laboratory tests that will be analyzed centrally within 7 days prior to the first dose of study drug. In case of multiple laboratory data within this period, the most recent data should be used.
    - Neutrophil count > 1,000/mm^3
    - Platelet count ≥ 7.5 x 10^4 /mm^3
    - Hemoglobin > 8.0 g/dL
    - Serum creatinine < 2.0 x upper limit of normal (ULN) or an estimated glomerular filtration rate (eGFR) of > 50 mL/min as calculated by the Cockcroft Gault Method
    Total bilirubin < 1.5 x ULN (except for subjects with documented Gilbert’s syndrome)
    AST and ALT < 3.0 x ULN or ≤ 5 x ULN if subject has documented liver metastases
    Serum sodium level is ≥ 130 mmol/L
    13. Subject has an EGFR activating mutation (exon 19 deletion or exon 21 L858R), with or without T790M mutation, by local or central testing on examination of a NSCLC FFPE specimen. A tissue sample from the same block used to determine eligibility by local testing should be available to send to the central lab for confirmatory testing.
    14. Subject must have at least 1 measureable lesion based on RECIST V1.1.
    Un patient doit répondre à la totalité des critères d’inclusion suivants pour pouvoir être inclus dans cette étude :
    1. Avant toute procédure liée à l’étude, le patient ou son représentant légal doit signer un formulaire de consentement éclairé ayant reçu l’avis favorable d’un comité d’éthique indépendant
    2. Patient âgé d’au moins 18 ans et majeur légal conformément à la réglementation nationale au moment de la signature du formulaire de consentement éclairé.
    3. Le patient accepte de ne pas participer à une autre étude interventionnelle durant le traitement de la présente étude.
    4. Une femme doit :
    • ne pas être en âge de procréer :
    o ménopausée (définie comme aménorrhéique depuis au moins un an) avant la sélection, ou
    o ayant des antécédents documentés de stérilisation chirurgicale
    • ou, si elle est en âge de procréer :
    o Accepter de ne pas tenter de débuter une grossesse durant l’étude et pendant les 28 jours suivant la dernière administration de médicament à l’étude
    o Présenter un test sérique de grossesse négatif à la sélection
    o Et, si elle est hétérosexuellement active, accepter d’utiliser constamment deux méthodes de contraception très efficaces* (dont au moins une devra être de type barrière) à partir de la sélection, pendant toute la durée de l’étude et pendant les 28 jours suivant la dernière administration de médicament à l’étude
    5. Les patientes ne devront pas allaiter à la sélection, pendant toute la durée de l’étude et pendant les 28 jours suivant la dernière administration de médicament à l’étude.
    6. Les patientes ne devront pas donner d’ovules à partir de la sélection, pendant toute la durée de l’étude et pendant les 28 jours suivant la dernière administration de médicament à l’étude.
    7. Les hommes et leurs conjointes/partenaires en âge de procréer devront utiliser deux méthodes de contraception très efficaces* (dont au moins une devra être de type barrière) à partir de la sélection, pendant toute la durée de l’étude et pendant les 90 jours suivant la dernière administration de médicament à l’étude.
    *Les formes de contraception très efficaces sont les suivantes :
    • Utilisation constante et correcte d’une méthode de contraception hormonale par voie orale, par injections ou par implants
    • Mise en place d’un dispositif intra-utérin (DIU) ou d’un système intra-utérin (SIU)
    • Méthodes de contraception de type barrière : préservatif ou cape occlusive (diaphragme ou cape cervicale) avec un spermicide (mousse, gel, film, crème ou ovule)
    8. Les patients ne devront pas donner de sperme à partir de la sélection, pendant toute la durée de l’étude et pendant les 90 jours suivant la dernière administration de médicament à l’étude.
    9. Le patient présente un indice de performance de l’ECOG (Eastern Cooperative Oncology Group) ≤ 2.
    10. Le patient présente un CBNPC (nouvellement diagnostiqué ou récurrent) confirmé par un examen histologique, de type adénocarcinome, de stade IIIB/IV et localement avancé, métastatique ou inopérable. Les patients présentant un CBNPC d’histologie mixte sont éligibles si l’histologie prédominante est celle d’un adénocarcinome.
    11. L’espérance de vie du patient est ≥ 12 semaines selon le jugement de l’investigateur.
    12. Les résultats des analyses biologiques effectuées chez le patient par le laboratoire central au cours des 7 jours précédant la première dose de médicament à l’étude doivent répondre à tous les critères suivants. En cas de données biologiques multiples durant cette période, les plus récentes devront être utilisées.
    • Numération des neutrophiles > 1 000/mm3
    • Numération plaquettaire ≥ 7,5 x 104/mm3
    • Hémoglobine > 8,0 g/dl
    • Créatininémie < 2,0 x la limite supérieure de la normale (LSN) ou débit de filtration glomérulaire estimé (DFGe) > 50 ml/min selon la formule de Cockcroft-Gault
    • Bilirubine totale < 1,5 x LSN (sauf en cas de syndrome de Gilbert documenté)
    • ASAT et ALAT  3,0  LSN ou ≤ 5  LSN si le patient présente des métastases hépatiques documentées
    • Natrémie ≥ 130 mmol/l
    13. La tumeur du patient présente une mutation activatrice de l’EGFR (délétion dans l’exon 19 ou L858R dans l’exon 21), avec ou sans mutation T790M, selon des tests locaux ou centraux d’un échantillon FFPE du CBNPC. Un échantillon de tissu provenant du bloc utilisé pour déterminer l’éligibilité par des tests locaux doit être disponible pour envoi au laboratoire central pour des tests de confirmation.
    14. Le patient doit présenter au moins une lésion mesurable selon les critères RECIST v 1.1.
    E.4Principal exclusion criteria
    Subject who meets any of the following exclusion criteria prior to enrollment is not eligible for enrollment:
    1. Subject has received intervening anticancer treatment or previous treatment with chemotherapy
    for metastatic disease. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized ≥ 6 months before the first dose of study drug.
    2. Subject has received a prior treatment with a therapeutic agent targeting EGFR (e.g., afatinib, dacomitinib, ASP8273, etc).
    3. Subject has received investigational therapy within 28 days or 5 half-lives prior to the first dose of study drug.
    4. Subject has received radiotherapy within 1 week prior to the first dose of study drug. If the subject received radiotherapy > 1 week prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response.
    5. Subject has symptomatic central nervous system (CNS) metastasis. Subject with previously treated brain or CNS metastases are eligible provided that the subject has recovered from any acute effects of radiotherapy and is not requiring escalating doses of steroids, and any whole brain radiation therapy was completed at least 2 weeks prior to study drug administration, or any stereotactic radiosurgery (SRS) was completed at least 1 week prior to the first dose of study drug.
    6. Subject has received blood transfusions or hematopoietic factor therapy within 14 days prior to the first dose of study drug.
    7. Subject has had a major surgical procedure (other than a biopsy) within 14 days prior to the first dose of study drug, or one is planned during the course of the study.
    8. Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection.
    9. Subject has known history of serious hypersensitivity reaction to a known ingredient of ASP8273, erlotinib or gefitinib.
    10. Subject has evidence of an active infection requiring systemic therapy within 14 days prior to the planned first dose of study drug.
    11. Subject has severe or uncontrolled systemic diseases including uncontrolled hypertension (blood pressure > 150/100 mmHg) or active bleeding diatheses.
    12. Subject has history of drug-induced interstitial lung disease (ILD) or any evidence of active ILD.
    13. Subject has ongoing cardiac arrhythmia that is Grade ≥ 2 or uncontrolled atrial fibrillation of any
    grade.
    14. Subject currently has Class 3 or 4 New York Heart Association congestive heart failure.
    15. Subject has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the planned first dose of study drug.
    16. Subject has history of gastrointestinal ulcer or gastrointestinal bleeding within 3 months prior to the planned first dose of study drug.
    17. Subject has concurrent corneal disorder or any ophthalmologic condition which, in the investigator’s opinion, makes the subject unsuitable for study participation (i.e., advanced cataracts, glaucoma).
    18. Subject has difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that would interfere with the intestinal absorption of drug.
    19. Subject has another malignancy which requires treatment.
    20. Subject has any condition which, in the investigator’s opinion, makes the subject unsuitable for study participation.
    21. Subject has used the following drugs:
    a. Potent CYP 3A4 inhibitors within 7 days prior to first dose of study drug
    b. Proton pump inhibitors such as omeprazole within 14 days prior to first dose of study drug
    Un patient répondant à l’un des critères d’exclusion suivant ne pourra être inclus dans l’étude :
    1. Le patient a reçu un traitement anticancéreux intercurrent ou a précédemment reçu une chimiothérapie pour forme métastatique. L’administration d’une chimiothérapie néoadjuvante ou adjuvante est autorisée si elle a été terminée ≥ 6 mois avant la première dose de médicament à l’étude.
    2. Le patient a été précédemment traité par un agent ciblant l’EGFR (par exemple afatinib, dacomitinib, ASP8273, etc.).
    3. Le patient a reçu un traitement expérimental au cours des 28 jours ou des 5 demi-vies précédant la première dose de médicament à l’étude.
    4. Le patient a reçu une radiothérapie au cours des 7 jours précédant la première dose de médicament à l’étude. Si le patient a reçu une radiothérapie plus de 7 jours avant le traitement à l’étude, la lésion irradiée ne devra pas être la seule lésion utilisée pour l’évaluation de la réponse.
    5. Le patient présente des métastases symptomatiques au système nerveux central (SNC). Un patient chez qui des métastases cérébrales ou au SNC ont été précédemment traitées est éligible s’il s’est rétabli de tous les effets aigus de la radiothérapie et ne nécessite pas de corticothérapie à dose croissante, et si une radiothérapie du cerveau entier a été terminée au moins 2 semaines avant l’administration du médicament à l’étude, ou si une intervention par radiochirurgie stéréotaxique (RCS) a été effectuée au moins une semaine avant la première dose de médicament à l’étude.
    6. Le patient a reçu des transfusions sanguines ou des facteurs hématopoïétiques au cours des 14 jours précédant la première dose de médicament à l’étude.
    7. Le patient a subi une intervention chirurgicale majeure (autre qu’une biopsie) au cours des 14 jours précédant la première dose de médicament à l’étude, ou une intervention de ce type est programmée au cours de l’étude.
    8 Le patient a des antécédents connus de séropositivité pour le virus de l’immunodéficience humaine (VIH).
    9 Le patient a des antécédents connus de réaction d’hypersensibilité grave à un composant connu de l’ASP8273, de l’erlotinib ou du géfitinib.
    10 Le patient présente des signes d’infection active nécessitant un traitement systémique au cours des 14 jours précédant la première dose prévue de médicament à l’étude.
    11 Le patient présente une maladie systémique sévère ou non contrôlée, y compris une hypertension non contrôlée (pression artérielle > 150/100 mm Hg) ou une diathèse hémorragique active.
    12 Le patient a des antécédents de pneumopathie interstitielle (PPI) d’origine médicamenteuse ou présente des signes de PPI active.
    13 Le patient présente des troubles du rythme cardiaque de grade ≥ 2 ou une fibrillation auriculaire non contrôlée de grade quelconque.
    14 Le patient présente une insuffisance cardiaque congestive supérieure de classe III ou IV de la New York Heart Association.
    15 Le patient a des antécédents d’angor sévère/instable, d’infarctus du myocarde ou d’accident vasculaire cérébral au cours des 6 mois précédant la première dose prévue de médicament à l’étude.
    16 Le patient a des antécédents d’ulcère gastro-intestinal ou de saignement gastro-intestinal au cours des 3 mois précédant la première dose prévue de médicament à l’étude.
    17 Le patient présente une affection de la cornée ou toute affection ophtalmologique qui, selon le jugement de l’investigateur, ne lui permet par de participer à l’étude (par exemple cataracte avancée, glaucome).
    18 Le patient éprouve des difficultés à prendre des médicaments par voie oral ou présente des troubles fonctionnels digestifs ou une maladie inflammatoire de l’intestin susceptibles d’interférer avec l’absorption du médicament à l’étude.
    19 Le patient présente une autre affection maligne qui nécessite un traitement.
    20 Le patient présente une affection ou est dans une situation qui, selon le jugement de l’investigateur, ne lui permet pas de participer à l’étude.
    21 Le patient a reçu l’un des médicaments suivants :
    a) Inhibiteur puissant de CYP 3A4 au cours des 7 jours précédant la première dose de médicament à l’étude
    b) Inhibiteur de la pompe à protons tel que l’oméprazole au cours des 14 jours précédant la première dose de médicament à l’étude
    E.5 End points
    E.5.1Primary end point(s)
    - PFS as assessed by IRR
    - SSP évaluée par ERI
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 36 months.
    36 mois au maximum
    E.5.2Secondary end point(s)
    - OS
    - Best overall response rate (CR + PR) by IRR
    - PFS by the investigator
    - DCR (CR+PR+SD) by IRR
    - Safety variables (e.g., adverse events [AEs], laboratory tests, vital sign measurements, electrocardiograms [ECGs])
    • SG
    • Taux global de meilleure réponse (RC + RP) par ERI
    • SSP selon l’évaluation de l’investigateur
    • TCM (RC+RP+MS) par ERI
    • Variables relatives à la sécurité d’emploi (par exemple événements indésirables [EI], analyses biologiques, mesures des signes vitaux, électrocardiogrammes [ECG])
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 36 months.
    36 mois au maximum
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Plasma biomarkers
    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 Yes
    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 Yes
    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) Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Chile
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    Portugal
    Romania
    Russian Federation
    Singapore
    Spain
    Taiwan
    Thailand
    Ukraine
    United Kingdom
    United States
    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
    The end of trial in all participating countries may be defined as the Last Subject’s Last Visit.
    La fin d'étude dans tous les pays participants est définie comme étant la dernière visite du dernier patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 265
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 275
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 540
    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 participation in the trial, patients will be treated with the current standard therapy in their country.
    Après leurparticipation à l'étude, les patients recevront les traitements habituels utilizes dans leur pays.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ERT
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-12-21
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 13:19:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA