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    Summary
    EudraCT Number:2015-004984-35
    Sponsor's Protocol Code Number:EZH-501
    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:2016-10-06
    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 number2015-004984-35
    A.3Full title of the trial
    Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study
    Étude d'extension du Tazemetostat (TRuST) : une étude d'extension en ouvert
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rollover Study for Tazemetostat
    Etude d'extension du Tazemetostat
    A.4.1Sponsor's protocol code numberEZH-501
    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 SponsorEpizyme, 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 supportEpizyme, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEpizyme, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address400 Technology Square, 4th Floor
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number001885500-1011
    B.5.6E-mailclinicaltrials@epizyme.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 nameTAZEMETOSTAT
    D.3.2Product code EPZ-6438 (E7438)
    D.3.4Pharmaceutical form 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 INNTAZEMETOSTAT
    D.3.9.2Current sponsor codeEPZ-6438
    D.3.9.3Other descriptive nameESQR
    D.3.9.4EV Substance CodeSUB178719
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 nameTAZEMETOSTAT
    D.3.2Product code EPZ-6438 (E7438)
    D.3.4Pharmaceutical form 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 INNTAZEMETOSTAT
    D.3.9.2Current sponsor codeEPZ-6438
    D.3.9.3Other descriptive nameESQR
    D.3.9.4EV Substance CodeSUB178719
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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 nameTAZEMETOSTAT
    D.3.2Product code EPZ-6438 (E7438)
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNTAZEMETOSTAT
    D.3.9.2Current sponsor codeEPZ-6438
    D.3.9.3Other descriptive nameESQR
    D.3.9.4EV Substance CodeSUB178719
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Subjects will receive tazemetostat as dictated in their antecedent study.
    Les patients recevront le Tazemetostat conformément aux prescriptions de l'étude précédente
    E.1.1.1Medical condition in easily understood language
    Subjects will receive tazemetostat as dictated in their antecedent study.
    Les patients recevront le Tazemetostat conformément aux prescriptions de l'étude précédente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level HLT
    E.1.2Classification code 10027414
    E.1.2Term Mesotheliomas malignant and unspecified
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10027404
    E.1.2Term Mesomelia
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10007284
    E.1.2Term Carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10027406
    E.1.2Term Mesothelioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10027408
    E.1.2Term Mesothelioma malignant advanced
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10026667
    E.1.2Term Malignant peripheral nerve sheath tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10073335
    E.1.2Term Rhabdoid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10042863
    E.1.2Term Synovial sarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10064886
    E.1.2Term Renal medullary carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10073134
    E.1.2Term Extraskeletal myxoid chondrosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10062474
    E.1.2Term Mesothelioma malignant localized
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10074121
    E.1.2Term Rhabdoid tumor of the kidney
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10027411
    E.1.2Term Mesothelioma malignant recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level HLT
    E.1.2Classification code 10015100
    E.1.2Term Epithelioid sarcomas
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level HLGT
    E.1.2Classification code 10027412
    E.1.2Term Mesotheliomas
    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
    1. Number of subjects with adverse events related to study drug, as a measure of safety and tolerability of tazemetostat
    2. Number of subjects with adverse events, as a measure of safety and tolerability of tazemetostat
    3. Extent of exposure to tazemetostat
    1. Nombre de patients présentant des événements indésirables liés au médicament à l'étude, comme mesure de la sécurité et de la tolérance du Tazemetostat.
    2. Nombre de patients présentant des événements indésirables, comme mesure de la sécurité et de la tolérance du Tazemetostat.
    3. Étendue de l'exposition au Tazemetostat.
    E.2.2Secondary objectives of the trial
    1. The overall survival (OS) of subjects receiving tazemetostat defined as the interval of time between the date of the first dose of tazemetostat and the date of death due to any cause
    1. Survie globale (SG) des patients recevant du Tazemetostat, définie comme le temps écoulé entre la date de la première prise du Tazemetostat et la date du décès quelle qu'en soit la cause.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
    2. Is currently receiving tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical trial or any other clinical trial being conducted with tazemetostat that is not sponsored by Epizyme (including but not limited to, investigator-initiated trials). For subjects on combination therapy, treatment with other therapeutic(s) must have been completed in the antecedent study or will be provided by a source other than Epizyme if combination therapeutics are continued in this study
    3. Has provided signed written informed consent
    4. Has a life expectancy of >3 months
    5. Has adequate hematologic, (bone marrow [BM], and coagulation factors), renal, and hepatic function. Subject must remain eligible for continued treatment with tazemetostat according to the eligibility and treatment criteria from the antecedent study
    6. For French subjects only: Is either affiliated with or a beneficiary of a social security category
    7. Female subjects of childbearing potential must:
    • Have a negative beta-human chorionic gonadotropin (β-hCG) pregnancy test at time of study entry and within 14 days prior to planned first dose of investigational product, and
    • Agree to use effective contraception, as defined in Section 10.4 until 30 days following the last dose of investigational product and have a male partner who uses a condom, or
    • Practice true abstinence (when this is in line with the preferred and usual lifestyle of the subject, see Section 10.4.1), or
    • Have a male partner who is vasectomized.
    8. Male subjects with a female partner of childbearing potential must:
    • Be vasectomized, or
    • Agree to use condoms as defined in Section 10.4.2 until 30 days following the last dose of investigational product, or
    •Have a female partner who is NOT of childbearing potential.
    1. Avoir clairement retiré et continuer à retirer un bénéfice clinique du traitement par Tazemetostat.
    2. Recevoir actuellement du Tazemetostat soit en monothérapie, soit en association avec un ou plusieurs autres médicaments autorisés ou agents expérimentaux dans le cadre d'une étude clinique menée par Epizyme ou de toute autre étude clinique portant sur le Tazemetostat dont Epizyme n'est pas le promoteur (y compris, mais sans s'y limiter, les études initiées par les investigateurs). Pour les patients prenant une polythérapie, le traitement par un ou plusieurs autres produits thérapeutiques doit avoir ététerminé lors de l'étude précédente ou sera fourni par une autre source qu'Epizyme si la polythérapie est poursuivie lors de cette étude.
    3. Avoir donné son consentement éclairé signé par écrit.
    4. Avoir une espérance de vie > 3 mois.
    5. Présenter une fonction hématologique (moelle osseuse [MO] et facteurs de coagulation), rénale et hépatique adéquate. Le patient doit rester éligible à la poursuite du traitement par le Tazemetostat selon les critères d'éligibilité et de traitement de l'étude précédente.
    6. Pour les patients français uniquement : être affilié ou être bénéficiaire d'un régime de la Sécurité sociale
    7. Les patients de sexe féminin en âge de procréer doivent :
    - Présenter un test de grossesse β-hCG (hormone chorionique béta-gonadotrophique humaine) négatif au moment de l'inclusion dans l'étude et dans les 14 jours précédant la prise prévue de la première dose du produit expérimental, et
    - Accepter d'utiliser une méthode de contraception efficace, telle que définie à la section 10.4 jusqu'à 30 jours après la prise de la dernière dose du produit expérimental, et avoir un partenaire qui utilise des préservatifs, ou
    - Pratiquer une véritable abstinence sexuelle (si cela est en accord avec les préférences et le mode de vie habituels du patient ; voir la section 10.4.1) ou
    - Avoir un partenaire qui a subi une vasectomie.
    8. Les patients de sexe masculin avec une partenaire en âge de procréer doivent :
    - Avoir subi une vasectomie ou
    - Accepter d'utiliser des préservatifs, comme défini à la section 10.4.2, jusqu'à 30 jours après la prise de la dernière dose du produit expérimental, ou
    -Avoir une partenaire qui n'est PAS en âge de procréer.
    E.4Principal exclusion criteria
    1. Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study
    2. Has any other malignancy other than the one for which they are receiving tazemetostat
    Exception: Subject who has been disease-free of a prior malignancy for 5 years, or subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible.
    3. Is unwilling to exclude grapefruit juice, Seville oranges, and grapefruit from the diet and all foods that contain those fruits from time of enrollment throughout their participation in the study.
    4. Is currently taking any prohibited medication(s) as described in Section 8.3.
    5. Is unable to take oral medications, has malabsorption syndrome, or has any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of tazemetostat
    6. Has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements.
    7. For female subjects of childbearing potential: Is pregnant or nursing
    8. Has been permanently discontinued from tazemetostat therapy due to adverse event, intolerance or treatment failure
    1. Avoir interrompu la prise du Tazemetostat pendant > 14 jours entre l'étude clinique précédente et le début de l'étude d'extension.
    2. Être atteint(e) d'une autre affection maligne que celle pour laquelle il/elle reçoit le Tazemetostat.
    Exception : un patient en rémission d'une affection maligne antérieure depuis 5 ans, ou avec des antécédents de cancer de la peau autre qu'un mélanome ayant fait l'objet d'une résection totale ou de carcinome in situ ayant été traité avec succès est éligible.
    3. Refuser d'exclure le jus de pamplemousse, les oranges amères et le pamplemousse de son régime alimentaire, ainsi que tous les aliments contenant ces fruits à compter de la date de recrutement et pendant la participation à l'étude.
    4. Prendre actuellement un ou plusieurs médicaments interdits tels que décrits à la section 8.3
    5. Ne pas être capable de prendre des médicaments par voie orale, souffrir d'un syndrome de malabsorption ou présenter une affection gastro-intestinale non contrôlée (nausées, diarrhée ou vomissements) qui pourrait affecter la biodisponibilité du Tazemetostat.
    6. Souffrir d'une maladie intercurrente non contrôlée y compris, mais non limité à, une infection non contrôlée, ou une maladie psychiatrique/des situations sociales qui limiteraient le respect des exigences de l'étude.
    7. Pour les patients de sexe féminin en âge de procréer : être enceinte ou allaitante.
    8. Avoir définitivement arrêté la prise de Tazemetostat pour cause d'événement indésirable, d'intolérance ou d'échec du traitement.
    E.5 End points
    E.5.1Primary end point(s)
    • AEs related to study drug
    • AEs
    • Duration of exposure to tazemetostat
    • Les EIs liés au produit à l'étude
    • Les EIs
    • Étendue de l'exposition au Tazemetostat.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At each visit
    A chaque visite
    E.5.2Secondary end point(s)
    • OS, defined as the interval of time between the date of the first dose of tazemetostat and the date of death due to any cause.
    • Survie globale (SG) des patients recevant du Tazemetostat, définie comme le temps écoulé entre la date de la première prise du Tazemetostat et la date du décès quelle qu'en soit la cause.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 2 years after completion of the study (data base lock).
    Jusqu'à 2 ans après completion de l'étude (vérouillage de la base de données)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) 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
    Rollover study
    Etude d'extension
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Australia
    Belgium
    Canada
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Taiwan
    United Kingdom
    United States
    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
    Dernière visite du dernier patient
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 14
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 255
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 300
    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 Decision2016-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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