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    Summary
    EudraCT Number:2016-001499-31
    Sponsor's Protocol Code Number:Epi-RCHOP
    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:2016-10-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2016-001499-31
    A.3Full title of the trial
    A Phase Ib-II Study of tazemetostat (EPZ-6438) in newly diagnosed Diffuse Large B Cell Lymphoma (DLBCL) patients with poor prognosis treated by R-CHOP
    Etude de phase Ib-II du tazemetostat (EPZ-6438) chez des patients
    atteints de lymphome diffus à grandes cellules B (DLBCL) de
    risque élevé traités par R-CHOP
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of tazemetostat in newly diagnosed Diffuse Large B Cell Lymphoma (DLBCL) patients treated by R-CHOP
    Etude du tazemetostat chez des patients atteints de lymphome diffus à grandes cellules B (DLBCL) traités par R-CHOP
    A.4.1Sponsor's protocol code numberEpi-RCHOP
    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 SponsorLYSARC
    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 supportEpizyme
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointProject Management - A Schwartzmann
    B.5.3 Address:
    B.5.3.1Street AddressCH Lyon Sud - Secteur Sainte Eugénie - Pav 6D
    B.5.3.2Town/ cityPierre Bénite Cedex
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number0033472 66 93 33
    B.5.5Fax number00334 26 07 40 55
    B.5.6E-mailalexia.schwartzmann@lysarc.org
    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
    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.3.9.1CAS number 1467052-75-0
    D.3.9.2Current sponsor codeEPZ-6438
    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.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
    newly diagnosed Diffuse Large B Cell Lymphoma (DLBCL)
    Lymphome B Diffus à Grande Cellule (DLBCL) à risque élevé
    E.1.1.1Medical condition in easily understood language
    Diffuse Large B Cell Lymphoma (DLBCL)
    Lymphome B Diffus à Grande Cellule (DLBCL)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase Ib: to determine the recommended phase II dose (RP2D) for tazemetostat in patients treated with R-CHOP 21

    Phase II:
    - to determine the safety of tazemetostat in patients treated with 8 cycles of R-CHOP 21
    - to determine the complete response rate according to Cheson IWG 2014: Lugano Classification (i.e. ; categories 1- 3 on the 5 point Deauville scale ) after 8 cycles of Epi-RCHOP 21
    Phase Ib: déterminer la dose recommandée de phase II (RP2D) dutazemetostat chez les patients traités par R-CHOP 21

    Phase II:
    - déterminer la sécurité du tazemetostat chez les patients traités par 8 cycles de R-CHOP 21
    - déterminer le taux de réponse complète selon Cheson IWG 2014: Classification de Lugano (à savoir, les catégories 1- 3 sur l'échelle de Deauville à 5 points) après 8 cycles de Epi-RCHOP 21
    E.2.2Secondary objectives of the trial
    Phase Ib:
    - to assess the pharmacokinetics of the CHOP 21 components +/- tazemetostat
    - to assess the pharmacokinetics of tazemetostat and its metabolite, EPZ-6930 + R-CHOP 21
    - to evaluate the preliminary anti-tumor activity of tazemetostat using Cheson IWG 2014

    Phase II:
    - to evaluate the overall response rate (ORR) and progression free survival (PFS) at 52 and 104 weeks and overall
    - to estimate the pharmacokinetics of the CHOP 21 components in +/-tazemetostat
    - to estimate the pharmacokinetics of tazemetostat and EPZ-6930 + R-CHOP 21

    Exploratory Objectives for Both Phases
    - to evaluate the duration of response and overall survival (OS) at 52 and 104 weeks and overall
    - to assess tumor tissue and/or blood for candidate markers of prognosis and clinical effect of tazemetostat,
    - to assess mutational landscape of HSC before and after tazemetostat therapy in case of hematological toxicity unexpected according to phase I DLT criteria.
    Phase Ib:
    • évaluer la pharmacocinétique des composants du CHOP 21 +/-tazemetostat
    • évaluer la pharmacocinétique du tazemetostat et de son métabolite, EPZ-6930 + R-CHOP 21
    • évaluer l'activité anti-tumorale préliminaire du tazemetostat selon Cheson IWG 2014

    Phase II:
    • évaluer le taux de réponse global et la survie sans progression à 52, 104 semaines et en fin d'étude
    • estimer les paramètres pharmacocinétiques des composants du CHOP 21 +/- tazemetostat
    • estimer les paramètres pharmacocinétiques du tazemetostat et de EPZ-6930 + R-CHOP 21


    Objectifs exploratoires pour les deux phases
    • évaluer la durée de la réponse et la survie globale (OS) à 52 et 104 semaines et sur l'ensemble de l'étude
    • évaluer le tissu tumoral et/ou de sang pour les marqueurs candidats de pronostic et pour l'effet clinique du tazemetostat,
    • Évaluer le paysage mutationnel du HSC avant et après tazemetostat en cas de toxicité hématologique inattendue selon les critères de DLT de la phase I .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with an untreated DLBCL de novo or transformed from indolent lymphoma (CD 20 positive) with aaIPI ≥ 2
    2. Age between 60 and 80 years included
    3. ECOG performance status of 0, 1 or 2 (0 or 1 only for phase Ib)
    4. Signed informed consent
    5. Life expectancy of ≥ 90 days (3 months) before starting tazemetostat
    6. Adequate renal function as calculated by a creatinine clearance > 40 mL/min by local institutional formula
    7. Adequate bone marrow function as defined as:
    - ANC ≥ 1500/mm3 (≥ 1.5 X 109/L)
    - Platelets ≥ 75,000/mm3 (≥ 75 X 109/L) without platelet transfusion dependency during the last 7 days
    - Hemoglobin ≥ 9 g/dL (may receive transfusion)
    8. Adequate liver function as defined as:
    - Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert’s syndrome
    - Alkaline phosphatase (in absence of bone disease), alanine aminotransferase (ALT) and asparatate aminotransferase (AST) ≤ 3 X ULN (or ≤ 5 X ULN if there is lymphoma involvement of the liver)
    - Patients with prior Hepatitis B and C are eligible if for Hepatitis B detection, surface antigen is negative and/or HBV DNA is undetectable, and for Hepatitis C detection, HCV RNA is undetectable.
    9. Left ventricular ejection fraction (LVEF) > 50% of echocardiography or multiple gated acquisition (MUGA) scan
    10. Adequate tissue for central retrospective testing of EZH2 mutation status and cell of origin (15 slides of tumor biopsy must be available at screening)
    11. Males with partners of childbearing potential must agree to use reliable forms of contraception
    1. patients avec un DLBCL non traité, de novo ou transformé d'un lymphome indolent (CD 20 positif) avec aaIPI ≥ 2
    2. entre 60 et 80 ans inclus
    3. statut de performance ECOG de 0, 1 ou 2 (0 ou 1 uniquement pour la phase Ib)
    4. consentement éclairé signé
    5. espérance de vie ≥ 90 jours (3 mois) avant de commencer le tazemetostat
    6. Fonction rénale adéquate = clairance de la créatinine> 40 ml / min par la formule institutionnelle locale
    7. Fonction de la moelle osseuse adéquate :
    - ANC ≥ 1500 / mm3 (≥ 1,5 x 109 / L)
    - plaquettes ≥ 75 000 / mm3 (≥ 75 x 109 / L) sans dépendance à la transfusion plaquettaire au cours des 7 derniers jours
    - Hémoglobine ≥ 9 g / dL (peut recevoir une transfusion)
    8. Fonction hépatique adéquate :
    - Bilirubine totale ≤ 1,5 x la limite supérieure de la normale (LSN), sauf pour l'hyperbilirubinémie du syndrome de Gilbert
    - Phosphatase alcaline (en l'absence de la maladie osseuse), alanine aminotransférase (ALT) et aspartate aminotransférase (AST) ≤ 3 x LSN (ou ≤ 5 x LSN en cas d'atteinte du foie)
    - les patients avec des antécédents d'hépatite B ou C sont admissibles si pour la détection de l'hépatite B, l'antigène de surface est négatif et / ou l'ADN du VHB est indétectable, et pour la détection de l'hépatite C, l'ARN du VHC est indétectable.
    9. Fraction d'éjection ventriculaire gauche (FEVG)> 50% de l'échocardiographie ou du scan MUGA
    10. Suffisamment de matériel pour réaliser les tests rétrospectifs centraux de l'état de mutation de EZH2 et de l'origine cellulaire (15 coupes de la biopsie de la tumeur doivent être disponibles au screening)
    11. Les hommes dont les partenaires sont en âge de procréer doivent accepter d'utiliser des formes de contraception fiables
    E.4Principal exclusion criteria
    1. Symptomatic central nervous system or meningeal involvement
    2. Contraindication to any drug contained in the chemotherapy regimen
    3. Prior treatment with tazemetostat or other inhibitor of EZH2
    4. Patients who are undergoing active treatment for another malignancy, exceptions include: A patient who has been disease free for 2 years, or a patient with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible
    5. Patients taking medications that are known potent CYP3A4 inducers/inhibitors (including St. John’s wort) or known substrates of CYP2C8.
    6. Patients unwilling to exclude Seville oranges, grapefruit juice and/or grapefruit from diet
    7. Major surgery within 4 weeks before first dose of study drug (minor procedures including transcutaneous biopsy, central line placement are permitted within 2 weeks of enrollment)
    8. Inability to take oral medication or malabsorption syndrome or any other uncontrolled gastrointestinal condition that would impare ability to take tazemetostat
    9. Significant cardiovascular impairment: congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of first dose of tazemetostat or ventricular arrhythmia
    10. Prolonged QTcF >480 msec
    11. Active uncontrolled infection requiring systemic therapy
    12. Congenital immunodeficiency or known HIV (human immunodeficiency virus infection)
    13. Any other major illness that in the investigator’s judgement, will substantially increase the risk associated with the patient’s participation in the study
    14. Patients who have undergone a solid organ transplant
    15. Previous treatment for B cell lymphoma, except low dose radiotherapy for follicular lymphoma and glucocorticoids (no more than 14 days before inclusion, 1 mg/kg/day max)
    1. Atteinte symptomatique du système nerveux central ou atteinte méningée
    2. Contre-indications à un médicament contenu dans le régime de chimiothérapie
    3. Traitement préalable avec tazemetostat ou un autre inhibiteur de la EZH2
    4. Patients qui suivent un traitement actif pour une autre tumeur maligne, sauf les exceptions suivantes: un patient en réponse complète pendant 2 ans, ou un patient ayant des antécédents d'un cancer de la peau non-mélanomateux complètement réséqué ou d'un carcinome in situ traité avec succès est admissible
    5. Patients prenant des médicaments connus comme inducteurs du CYP3A4 / inhibiteurs puissants (y compris le millepertuis) ou des substrats connus de CYP2C8.
    6. Patients ne voulant pas exclure les oranges de Séville, le jus de pamplemousse et / ou de pamplemousse de leur régime alimentaire
    7. Chirurgie majeure dans les 4 semaines avant la première dose de médicament à l'étude (les procédures mineures, y compris la biopsie transcutanée, le placement de la ligne centrale sont autorisés dans les 2 semaines avant l'inclusion)
    8. Incapacité à prendre des médicaments par voie orale ou syndrome de malabsorption ou toute autre affection gastro-intestinale non contrôlée qui empêcherait la capacité à prendre le tazemetostat
    9. insuffisance cardiovasculaire significative: insuffisance cardiaque congestive >Classe II selon la classification de la New York Heart Association (NYHA), angor instable, infarctus du myocarde ou accident vasculaire cérébral dans les 6 mois précédant la première dose de tazemetostat ou arythmie ventriculaire
    10. QTcF prolongée > 480 msec
    11. infection active incontrôlée nécessitant un traitement systémique
    12. immunodéficience congénitale ou infection au VIH connue
    13. Toute autre maladie grave qui selon le jugement de l'investigateur, augmenterait considérablement le risque associé à la participation du patient dans l'étude
    14. Patients ayant subi une transplantation d'organe solide
    15. Traitement précédent pour le lymphome à cellules B, à l'exception de radiothérapie de faible dose pour le lymphome folliculaire et les glucocorticoïdes (pas plus de 14 jours avant l'inclusion, 1 mg / kg / jour max)
    E.5 End points
    E.5.1Primary end point(s)
    Phase I :
    - RP2D

    Phase II
    - safety
    - CR
    Phase I :
    - Dose recommandée pour la phase II

    Phase II
    - sécurité
    - CR
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I
    - RP2D = 2 cycles

    Phase II
    - sécurité = 8 cycles
    - CR = 8 cycles
    Phase I
    - RP2D = 2 cycles

    Phase II
    - sécurité = 8 cycles
    - CR = 8 cycles
    E.5.2Secondary end point(s)
    Phase I :
    - PK CHOP21 +/- tazemetostat
    - PK tazemetostat and EPZ-6930 + CHOP 21
    - CR

    Phase II
    - ORR
    - PFS
    - PK CHOP21 +/- tazemetostat
    - PK tazemetostat and EPZ-6930 + CHOP 21
    - OS


    Phase I :
    - PK CHOP21 +/- tazemetostat
    - PK tazemetostat et EPZ-6930 + CHOP 21
    - CR

    Phase II
    - ORR
    - PFS
    - PK CHOP21 +/- tazemetostat
    - PK tazemetostat et EPZ-6930 + CHOP 21
    - OS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I
    - PK CHOP21 +/- tazemetostat = C1D1 and C2D1
    - PK tazemetostat and EPZ-6930 + CHOP 21 = C1D1 and C2D1
    - CR = 8 cycles

    Phase II
    - ORR = 52 and 104 days, end of study
    - PFS = 52 and 104 days, end of study
    - PK CHOP21 +/- tazemetostat = C1D1 and C2D1
    - PK tazemetostat and EPZ-6930 + CHOP 21 = C1D1 and C2D1
    Phase I
    - PK CHOP21 +/- tazemetostat = C1D1 et C2D1
    - PK tazemetostat and EPZ-6930 + CHOP 21 = C1D1 et C2D1
    - CR = 8 cycles

    Phase II
    - ORR = 52 et 104 jours, fin d'étude
    - PFS = 52 et 104 jours, fin d'étude
    - PK CHOP21 +/- tazemetostat = C1D1 and C2D1
    - PK tazemetostat and EPZ-6930 + CHOP 21 = C1D1 and C2D1
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) 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
    RP2D
    Dose pour la phase II
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    LVLP
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 133
    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)
    not different from the expected normal treatment of that condition
    pas différent de la prise en charge normale pour le traitement de cette pathologie
    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 LYSA
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-08-09
    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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