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    Summary
    EudraCT Number:2014-001578-32
    Sponsor's Protocol Code Number:2012/49
    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:2015-01-07
    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 number2014-001578-32
    A.3Full title of the trial
    A phase I/II study of pazopanib in combination with temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and RT-CT (PAZOGLIO study)
    Étude de phase I/II visant à évaluer, chez les patients opérés d'un Glioblastome puis traités par Radiothérapie-TEMOZOLOMIDE en induction, l'efficacité et la tolérance de l'association du PAZOPANIB au TEMOZOLOMIDE comme traitement d'entretien
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase I/II study of pazopanib in combination with temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and RT-CT (PAZOGLIO study)
    Étude de phase I/II visant à évaluer, chez les patients opérés d'un Glioblastome puis traités par Radiothérapie-TEMOZOLOMIDE en induction, l'efficacité et la tolérance de l'association du PAZOPANIB au TEMOZOLOMIDE comme traitement d'entretien
    A.3.2Name or abbreviated title of the trial where available
    PAZOGLIO
    A.4.1Sponsor's protocol code number2012/49
    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 ANTOINE LACASSAGNE
    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 supportGlaxoSmithKline
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCENTRE ANTOINE LACASSAGNE
    B.5.2Functional name of contact pointDr ESMA SAADA
    B.5.3 Address:
    B.5.3.1Street Address33, avenue de VALOMBROSE
    B.5.3.2Town/ cityNICE
    B.5.3.3Post code06189
    B.5.3.4CountryFrance
    B.5.4Telephone number+33492031495
    B.5.5Fax number+33492031030
    B.5.6E-mailesma.saada-bouzid@nice.unincancer.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 VOTRIENT
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Royaume-Uni.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameVOTRIENT
    D.3.2Product code GW786034
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    Glioblastoma
    E.1.1.1Medical condition in easily understood language
    glioblastoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I
    -To evaluate the Recommended Phase 2 Dose (RP2D) of pazopanib in oral route in addition to the maintenance phase of the Stupp protocol.
    -To evaluate the Maximal Tolerated Dose (MTD i.e the highest dose administered for which > 33% of patients experienced a DLT i.e an adverse event which severity may limit the escalation of the doses) associated with the concomitant administration of pazopanib during the maintenance phase of the “Stupp protocol”.
    Phase II
    -To evaluate the efficacy (Progression-Free-Survival rate at 6 Months ie. Rate of no progression at 6 months) of pazopanib in oral route in addition to the maintenance phase of the Stupp protocol.
    Phase I
    • Déterminer la Dose Recommandée (DR) à administrer en phase II du pazopanib par voie orale en phase d’entretien du « protocole STUPP ».
    • Déterminer la Dose Maximale Tolérée (DMT) du pazopanib associé au TMZ pendant la phase d’entretien du « protocole STUPP ».
    Phase II
    • Evaluer l’efficacité, en termes de survie sans progression à 6 mois, du pazopanib par voie orale en phase d’entretien du « protocole STUPP ».
    E.2.2Secondary objectives of the trial
    -To define the overall tolerance of pazopanib associated with TMZ during the maintenance phase of the “Stupp protocol”.
    -To assess the antitumor activity of the adjunction of daily dose of pazopanib to the maintenance phase of the Stupp protocol according to the Revised Assessment in Neuro-Oncology (RANO) criteria (response rate) and the median duration of response.
    -To determine the median Progression-Free-Survival (mPFS), the PFS rate at 12 (PFS-12) months.
    -To determine the median Overall Survival (mOS), the OS rate at 6 (OS-6) and 12 (OS-12) months.
    -To determine the pharmacokinetics (PK) profile of pazopanib when given in combination with TMZ.
    -To determine the pharmacokinetics (PK) profile of TMZ when given in combination with pazopanib.
    Ancillary study:
    -Pharmacogenetics and pharmacogenomics analysis of VEGF family.
    -To characterize tumor response to treatment by the association of MRI and 18F-DOPA PET imaging.
    • Définir la tolérance globale du pazopanib associé au « protocole STUPP » en phase d'entretien.
    • Evaluer l’activité anti-tumorale de l’ajout du pazopanib en phase d'entretien du « protocole STUPP ».
    • Déterminer la médiane de la Survie Sans Progression (SSP), le taux de survie sans progression à 12 mois.
    • Déterminer la médiane de Survie Globale (SG), le taux de survie globale à 6 et 12 mois.
    • Etudier la pharmacocinétique (PK) du pazopanib administré en combinaison avec le TMZ.
    • Etudier la pharmacocinétique (PK) du TMZ administré en combinaison avec le pazopanib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Deviations from inclusion criteria are not allowed because deviations can potentially jeopardize the scientific integrity of the study, regulatory acceptability, or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
    1) Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
    Note: Informed consent may be obtained prior to start of the specified screening window.
    Note: Procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent, may be utilized for screening or baseline purpose,s provided these procedures are conducted as specified in the protocol
    2) Age ≥ 18 years and < 70 years
    3) Histologically confirmed diagnosis of GBM
    4) Surgically treated other than exclusive biopsy (complete or partial resection) of the GBM, for which adjuvant radiotherapy and chemotherapy is indicated
    5) Eligibility criteria that will need to be checked before patient registration and dose assignment: during the induction phase,
    - No TMZ interruption resulting in hematological toxicity should has occurred
    - AND the delivery of radiation dose as defined in the Stupp protocol should be at least equal to 80%
    6) Eastern Cooperative Oncology Group (ECOG) performance status of Glioblastoma ≤ 2
    7) Life expectancy>3 months
    8) Measurable disease criteria : Based on the RANO criteria (Wen 2010) objective tumor response will be assessed by MRI and 18F-DOPA PET)
    9) Archived tumor tissue must be available for all subjects for biomarker analysis before and/or during treatment with investigational product.
    10) Stable doses of corticosteroid for more than 1 week.
    12) Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception, as defined in Pregnancy Section in overall Safety Section during the study and for 6 months following the last dose of investigational product.
    13) Patient with a social security category (French regulatory).
    1. Patients ayant pris connaissance de la note d’information et ayant signé le consentement éclairé.
    2. Patients âgés de Age ≥ 18 ans et < à 70 ans.
    3. Patients dont le diagnostic de GBM supratentoriel est confirmé par histologie avec résection complète ou partielle et pour lesquels une chimiothérapie-radiothérapie adjuvante est indiquée.
    4. Indice de performance ECOG (Eastern Cooperative Oncology Group) doit se situer entre 0 et 1 ou l'Indice de Karnofsky entre 80 et 100 %.
    5. Disponibilité de tissu tumoral pour tous les patients en vue de l'analyse des biomarqueurs avant et /ou pendant le traitement avec le produit expérimental.
    6. Dose de corticostéroïdes stable depuis plus d'une semaine.
    7. Espérance de vie d'au moins trois mois.
    8. Fonctions hématologiques, biologiques et rénales normales : Fonction hématologique normale (neutrophiles (PNN) ≥ 1.5 x 109/L, hémoglobine ≥ 9 g/dL (5.6 mmol/L), plaquettes ³ 100 x 109/L). Absence de troubles de la coagulation ou bilan d’hémostase normal (TCA ≤ 1,2 LNS, TP ou INR ≤ 1,2 LNS) sans transfusion dans les 7 jours qui précèdent le bilan hématologique. Fonction rénale normale (créatinine < 1.5 mg/dL (133μmol/L) et rapport protéine/créatinine urinaires (UPC) < 1. Si créatinine ≥ 1.5mg/dL, la clairance de la créatinine devra être ≥ 50 mL/min. Si UPC ≥ 1, une protéinurie des 24 h devra être < 1 g pour que le patient soit éligible),
    a. les patients recevant un traitement anticoagulant sont éligibles si l’INR est stable
    9. Les femmes en âge de procréer doivent présenter un test de grossesse sanguin négatif dans les 14 jours précédant l'administration de la première dose de médicament expérimental et 6 mois après la dernière dose du produit à l'étude et doivent accepter d'utiliser un moyen de contraception efficace tout au long de l'étude, tel que défini dans la section Grossesse de la partie Sécurité.
    10. Un patient sera éligible pour participer à cette étude uniquement s'il est ayant-droit ou bénéficiaire de la sécurité sociale.
    E.4Principal exclusion criteria
    Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
    1. prior malignancy.
    2. Surgical treatment consisting in exclusive biopsy or absence of initial surgery
    3. Pre-treated GBM
    4. Allergy to any of the tested drugs
    5. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
    • Active peptic ulcer disease
    • Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn’s disease), or other gastrointestinal conditions with increased risk of perforation
    • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
    6. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
    • Malabsorption
    • Major resection of the stomach or small bowel.
    7. Corrected QT interval (QTc) > 480 msecs
    Note: Correction method should be reported in CRT
    8. History of any one or more of the following cardiovascular conditions within the past 6 months:
    • Cardiac angioplasty or stenting
    • Myocardial infarction
    • Unstable angina
    • Coronary artery bypass graft surgery
    • Symptomatic peripheral vascular disease
    • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) (To be added as an Appendix in the protocol)
    9. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
    Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals. At least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement. These three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure. The mean SBP / DBP ratio must be <140/90 mmHg (OR 150/90 mm Hg, if this criterion is approved by Safety Review Team) in order for a subject to be eligible for the study.
    10. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
    Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
    11. Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
    12. Evidence of active bleeding or bleeding diathesis.
    13. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage
    Note: Lesions infiltrating major pulmonary vessels (contiguous tumour and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions).
    • Large protruding endobronchial lesions in the main or lobar bronchi are excluded; however, endobronchial lesions in the segmented bronchi are allowed.
    • Lesions extensively infiltrating the main or lobar bronchi are excluded; however, minor infiltrations in the wall of the bronchi are allowed.
    14. Recent hemoptysis (½ teaspoon of red blood within 8 weeks before first dose of study drug).
    15. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures.
    16. Unable or unwilling to discontinue use of prohibited medications listed in Appendix C for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study (Appendix C).
    17. Treatment with any of the following anti-cancer therapies:
    • radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazoapnib OR
    • chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of Pazopanib
    18. Administration of any non-oncologic investigational drug within 30 days or 5 half-lives whichever is longer prior to receiving the first dose of study treatment
    19. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
    1.Traitements antérieurs par cytotoxique ou radiothérapie du glioblastome.
    2.Traitement chirurgical qui consiste en une biopsie exclusive ou absence de chirurgie initiale
    3.Anomalies gastro-intestinales cliniquement significatives susceptibles d'augmenter le risque de saignement gastro-intestinal

    4. Anomalies gastro-intestinales cliniquement significatives susceptibles d'affecter l'absorption du produit expérimental,
    5. Intervalle QT corrigé (QTc) > 480 ms
    6. Antécédents de maladie cardiovasculaire dans les six derniers mois
    7. Hypertension mal contrôlée (définie comme une pression artérielle systolique ou PAS ≥140 mm Hg ou pression artérielle diastolique ou PAD ≥ 90 mm Hg).
    9. Chirurgie ou traumatisme majeurs survenus dans les 28 jours précédant la première administration de médicament expérimental ou présence d’une plaie non cicatrisée, d'une fracture ou d'un ulcère (les procédures telles que la mise en place d'un cathéter ne sont pas considérées comme des chirurgies majeures).
    10. Saignement actif ou diathèse hémorragique.
    11. Lésions endobronchiales connues ou lésions infiltrant les principaux vaisseaux pulmonaires, augmentant le risque d'hémorragie pulmonaire.
    12. Hémoptysie récente ( ½ cuillère à café de sang rouge dans les huit semaines précédant la première administration du médicament de l'étude).
    13. Antécédents de cancer, à l’exception des cancers en, rémission complète depuis plus de 5 ans, des carcinomes baso-cellulaire cutanés totalement réséqués, des carcinomes in situ ou épithélioma in situ du col utérin traités.
    14. Toute affection préexistante grave ou instable, médicale, psychiatrique ou autre, susceptible de menacer la sécurité du patient, le consentement éclairé ou le respect des procédures de l'étude.
    15. Patient incapable ou refusant d'arrêter les médicaments interdits (inhibiteurs puissants du CYP3A4 susceptibles d'augmenter les concentrations plasmatiques de pazopanib ou substrats de CYP3A4, CYP2C8 et CYP2D6 avec une fenêtre thérapeutique étroite) (cf section 6.9.2), pendant au moins 14 jours ou cinq demi-vies du médicament (le plus long des deux) avant la première administration du médicament expérimental et pendant la durée de l'étude. Les inducteurs du CYP3A4 doivent être évités car ils risquent de réduire les concentrations plasmatiques de pazopanib.
    16. Les antiépileptiques inducteurs d'enzyme (EIAED) ne sont pas autorisés (cf section 6.9.2).
    17. Le traitement par l'un des traitements anticancéreux suivants:
    a. radiothérapie, chirurgie ou embolisation tumorale dans les 14 jours avant la première dose de pazopanib
    OU
    b. chimiothérapie, immunothérapie, thérapie biologique, traitement expérimental ou hormonothérapie dans les 14 jours ou cinq demi-vies d'un médicament (période la plus longue) avant la première dose de pazopanib
    18. Administration d'un médicament expérimental non anticancéreux dans les 30 jours ou les cinq demi-vies (le plus long des deux) précédant la première administration du médicament de l'étude.
    19. Les personnes vulnérables sont définies à l'article L1121-5 à -8 :
    • Les femmes enceintes, les parturientes et les mères qui allaitent,
    • Les personnes privées de liberté par une décision judiciaire ou administrative, les personnes hospitalisées sans consentement en vertu des articles L. 3212-1 et L. 3213-1 qui ne relèvent pas des dispositions de l'article L. 1121-8
    • et les personnes admises dans un établissement sanitaire ou social à d'autres fins que celle de la recherche
    • Les personnes majeures faisant l'objet d'une mesure de protection légale ou hors d'état d'exprimer leur consentement
    20. Toute participation à d’autres études biomédicales est interdite sauf les études ne portant pas sur les médicaments, dispositifs et produits.
    21. Personnes privées de liberté ou sous tutelle.
    22. Toute toxicité présente liée à un traitement anti-cancéreux antérieur de grade > 1 et/ou évoluant, excepté l’alopécie.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I
    -To evaluate the Recommended Phase 2 Dose (RP2D) of pazopanib in oral route in addition to the maintenance phase of the Stupp protocol.
    -To evaluate the Maximal Tolerated Dose (MTD i.e the highest dose administered for which > 33% of patients experienced a DLT i.e an adverse event which severity may limit the escalation of the doses) associated with the concomitant administration of pazopanib during the maintenance phase of the “Stupp protocol”.
    Phase II
    -To evaluate the efficacy (Progression-Free-Survival rate at 6 Months ie. Rate of no progression at 6 months) of pazopanib in oral route in addition to the maintenance phase of the Stupp protocol.
    Phase I
    • Evaluer la Dose Maximale Tolérée (DMT) du pazopanib administré par voie orale associé au TMZ durant la phase d’entretien du « protocole Stupp », entrainant plus de 33% de toxicité dose limitante.
    • Evaluer la Dose Recommandée (DR) du pazopanib administré par voie orale associé au TMZ durant la phase d’entretien du « protocole Stupp ».

    Phase II
    Évaluation tumorale : l'évaluation de la réponse tumorale est effectuée sur des évaluations IRM selon les critères de RANO :
     Réponse complète (RC)
     Réponse partielle (RP)
     Stabilisation (S)
     Progression (P)
    Le taux de réponse objective est défini comme la somme des RC et des RP. L’évaluation tumorale (RC, RP, S, P) sera décrite toutes les 12 semaines jusqu'à la progression.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months of treatment
    E.5.2Secondary end point(s)
    -To define the overall tolerance of pazopanib associated with TMZ during the maintenance phase of the “Stupp protocol”.
    -To assess the antitumor activity of the adjunction of daily dose of pazopanib to the maintenance phase of the Stupp protocol according to the Revised Assessment in Neuro-Oncology (RANO) criteria (response rate) and the median duration of response.
    -To determine the median Progression-Free-Survival (mPFS), the PFS rate at 12 (PFS-12) months.
    -To determine the median Overall Survival (mOS), the OS rate at 6 (OS-6) and 12 (OS-12) months.
    -To determine the pharmacokinetics (PK) profile of pazopanib when given in combination with TMZ.
    -To determine the pharmacokinetics (PK) profile of TMZ when given in combination with pazopanib.
    Ancillary study:
    -Pharmacogenetics and pharmacogenomics analysis of VEGF family.
    -To characterize tumor response to treatment by the association of MRI and 18F-DOPA PET imaging.
    • La survie globale (SG) est définie comme le délai entre la date d’inclusion et la date du décès du patient quelle que soit la cause. Les patients qui ne sont pas décédés au moment de l'analyse ou qui sont perdus de vue seront censurés à la date des dernières nouvelles.
    • La Survie Sans Progression (SSP) est définie comme le délai entre la date d'inclusion et la date de la progression documentée (critères de RANO) ou toute cause de décès d’un patient pendant l'étude. Les patients n’ayant pas eu l’évènement au moment de l’analyse seront censurés à la date de la dernière évaluation tumorale. La SSP sera calculée à 6 et 12 mois.
    • Les paramètres pharmacocinétiques suivants seront évalués: Cmax, aire sous la courbe, Tmax , t1/2 pour chaque palier de dose.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 month of treatment
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Chemotherapy combination
    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 No
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 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 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 years3
    E.8.9.1In the Member State concerned months8
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 51
    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)
    to the discretion of the investigators
    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 Decision2014-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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