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    Summary
    EudraCT Number:2015-002469-41
    Sponsor's Protocol Code Number:EZH-202
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-12
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-002469-41
    A.3Full title of the trial
    A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Effect of Tazemetostat (study drug) in Patients with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma
    A.4.1Sponsor's protocol code numberEZH-202
    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 number001855500-1011
    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.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
    Cohort 1: Rhabdoid tumors (malignant rhabdoid tumors, rhabdoid tumors of the kidney, atypical teratoid rhabdoid tumors, and selected tumors
    Cohort 2: Relapsed/refractory synovial sarcoma with SS18-SSX rearrangement
    Cohort 3: Other INI1-negative tumors or any solid tumor with EZH2 GOF (gain of function) mutation
    Cohort 4: Renal medullary carcinoma
    Cohort 5 and 8: Epithelioid sarcoma
    Cohort 6: Epithelioid sarcoma undergoing mandatory tumor biopsy
    Cohort 7: Poorly differentiated chordoma
    E.1.1.1Medical condition in easily understood language
    INI1-negative tumors and synovial sarcoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 21.1
    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 21.0
    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 21.1
    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 21.1
    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 20.0
    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 20.0
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10008747
    E.1.2Term Chordoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the Overall Response Rate (ORR) in subjects with rhabdoid tumors (Cohort 1), other INI1-negative tumors or any solid tumor with EZH2 GOF mutation (Cohort 3), renal medullary carcinoma (Cohort 4), epithelioid sarcoma (Cohort 5), and chordoma (Cohort 7) following oral administration of tazemetostat 800 mg twice daily (BID);

    To determine the progression-free survival (PFS) rate after 16 weeks of treatment with tazemetostat in subjects with relapsed/refractory synovial sarcoma (Cohort 2) following oral administration of tazemetostat 800 mg BID

    Cohort 6 (epithelioid sarcoma undergoing mandatory tumor biopsy):
    To assess the effects of tazemetostat on tumor immune priming (e.g., PD-L1 and CD8 IHC)

    To assess the safety and tolerability of tazemetostat 1600 mg QD (Cohort 8)
    E.2.2Secondary objectives of the trial
    - To evaluate duration of response in subjects from Cohorts 1-7 and in Cohorts 1, 3, 4, 5, 6 and 7 combined for subjects achieving a complete response (CR) or partial response (PR) after oral admin of tazemetostat 800 mg BID and in subjects with epithelioid sarcoma in Cohort 8 at 1600 mg QD;
    - To assess: disease control rate (DCR) in subjects in Cohort 5 and 6 after oral admin of tazemetostat 800 mg BID and in subjects in Cohort 8 following oral admin of tazemetostat 1600 mg QD;
    - To assess the ORR in subjects in Cohort 2 and 6 after oral admin of tazemetostat 800 mg BID and in subjects in Cohort 8 following oral admin of tazemetostat 1600 mg QD;
    - To determine PFS and OS at Week 24, 32 & 56 & overall in subjects in Cohort 1-7 after oral admin of tazemetostat 800 mg BID and in subjects in Cohort 8 following oral admin of tazemetostat 1600 mg QD;
    - To assess safety and tolerability of IMP (Cohort 1-7);
    - To assess PK of IMP;
    - To investigate the PD effects of IMP in tumor tissue
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age(at the time of consent/assent): ≥18 years of age
    2.Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
    NOTE: If subject is unable to walk due to paralysis, but is mobile in a wheelchair, subject is considered to be ambulatory for the purpose of assessing their performance status
    3.Has provided signed written informed consent
    4.Has a life expectancy of >3 months
    5.Has a malignancy:
    •For which there are no standard therapies available (Cohorts 1, 3, 4&5)
    •That is relapsed or refractory, defined as metastatic or non-resectable, locally advanced disease that has previously been treated with and progressed following approved therapy(ies), if therapy(ies) exists (Cohort 2)
    •That has progressed within 6 months prior to study enrollment (Cohort 5 Expansion,Cohort 6 and 8 ONLY)
    6.Has a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) or other Sponsor-approved laboratory certification
    7.For Cohort 1 (subjects with rhabdoid tumors only): The following test results must be available by local laboratory:
    •Morphology and immunophenotypic panel consistent with rhabdoid tumors, and
    •Loss of INI1 or SMARCA4 confirmed by IHC, or
    •Molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation when INI1 or SMARCA4 IHC is equivocal or unavailable
    8.For Cohort 2 (subjects with relapsed/refractory synovial sarcoma only): The following test results must be available by local laboratory:
    •Morphology consistent with synovial sarcoma, and
    •Cytogenetics or Fluorescence in situ hybridization (FISH) and/or molecular confirmation (e.g., DNA sequencing) of SS18 rearrangement t(X;18)(p11;q11)
    9.For Cohort 3,4, 5, 7 and 8 (subjects with INI1-negative tumor or any solid tumor with EZH2 GOF mutation only): The following test results must be available by local laboratory:
    •Morphology and immunophenotypic panel consistent with INI1-negative tumors (not applicable for solid tumors with EZH2 GOF mutation), and
    •Loss of INI1 confirmed by IHC, or
    •Molecular confirmation of tumor bi-allelic INI1 loss or mutation when INI1 IHC is equivocal or unavailable, or
    •Molecular evidence of EZH2 GOF mutation
    10.For Cohort 6 (subjects with epithelioid sarcoma undergoing mandatory tumor biopsy):
    •Morphology and immunophenotypic panel consistent with epithelioid sarcoma (e.g., CD34, EMA, Keratin, and INI1)
    •Tumor that is accessible for mandatory biopsy
    Note: Subjects who are unable to undergo pre-dose (screening biopsy) will not be eligible
    •Willingness to provide informed consent to undergo pre- and post-dose biopsy
    11. Has all prior treatment (i.e., chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ≤ Grade 1 per CTCAE, version 4.03 or are clinically stable and not clinically significant, at time of enrollment
    12.Prior anti-cancer therapy(ies) according to the criteria described in the protocol.
    13.Has sufficient tumor tissue (slides or blocks) available for central confirmatory testing of IHC and/or cytogenetics/FISH and/or DNA mutation analysis (required for study entry but enrollment based on local results).
    14.Has measurable disease based on either RECIST 1.1 for solid tumors or RANO for CNS tumors as defined in the protocol.
    15.Has adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function as defined by criteria in the protocol.
    16.For subjects with CNS tumors only: Subject must have seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of 21 days prior to the planned first dose of tazemetostat
    17.Has a shortening fraction of >27% or an ejection fraction of ≥50% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan and New York Heart Association (NYHA) Class less than or equal to 2
    18.Has a QT interval corrected by Fridericia's formula (QTcF) ≤480 msec
    19.Female subjects of childbearing potential must:
    •Have a negative beta-human chorionic gonadotropin (β-hCG) pregnancy test at time of Screening and within 14 days prior to planned first dose of tazemetostat (urine or serum test is acceptable however, positive urine tests must be confirmed with serum testing), and
    •Agree to use effective contraception, as defined in the protocol, from start of screening until 30 days following the last dose of tazemetostat and have a male partner who uses a condom, or
    •Practice true abstinence, or
    •Have a male partner who is vasectomized
    20.Male subjects with a female partner of childbearing potential must:
    •Be vasectomized, or
    •Agree to use condoms, from first dose of tazemetostat until 30 days following the last dose of tazemetostat, or
    •Have a female partner who is NOT of childbearing potential
    21.For French subjects only: Is either affiliated with or a beneficiary of a social security category
    E.4Principal exclusion criteria
    1.Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2 (EZH2)
    2.Has participated in another interventional clinical study and received investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the planned first dose of tazemetostat
    3. Has known active CNS or any leptomeningeal metastasis of primary extra-cranial tumor. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging 4 weeks prior to the first dose of study drug and any neurologic symptoms have stabilized), have no evidence of new or enlarging brain metastases, and are on stable or tapering doses of steroids for at least 7 days prior to first dose of study drug.
    NOTE: Subjects with asymptomatic brain metastases found on screening MRI may be entered into the study without prior radiation therapy to the brain if they do not require immediate surgical or radiation therapy in the opinion of the treating Investigator and in the opinion of a radiation therapy or neurosurgical consultant.
    4.Has had a prior malignancy other than the malignancies under study
    Exception: Subject who has been disease-free for 5 years, or a subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible.
    5.Has had major surgery within 3 weeks prior to enrollment
    NOTE: Minor surgery (e.g., minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment.
    6.Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per
    CTCAE 4.03 criteria) or any prior history of myeloid malignancies,
    including myelodysplastic syndrome (MDS). Has abnormalities known to
    be associated with MDS (e.g. del 5q, chr 7 abn) and MPN (e.g. JAK2
    V617F) observed in cytogenetic testing and DNA sequencing.
    NOTE: Bone marrow aspirate/biopsy will be conducted following
    abnormal peripheral blood smear morphology assessment conducted by
    central laboratory. Cytogenetic testing and DNA sequencing will be
    conducted following an abnormal result of bone marrow aspirate/biopsy.
    7.Has a prior history of T-LBL/T-ALL.
    8.Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit
    from the diet and all foods that contain those fruits from time of
    enrollment to while on study.
    9.Has cardiovascular impairment, history of congestive heart failure
    greater than NYHA Class II, uncontrolled arterial hypertension, unstable
    angina, myocardial infarction, or stroke within 6 months prior to the
    planned first dose of tazemetostat; or ventricular cardiac arrhythmia
    requiring medical treatment
    10.Is currently taking any prohibited medication(s) as described in the protocol.
    NOTE: Subjects with a history of hepatitis B or C with normal ALT and
    undetectable HBV DNA or HCV RNA are eligible for this study;
    11.Has an active infection requiring systemic treatment
    12.Is immunocompromised (ie has a congential immunodeficiency),
    including subjects known history of infection with human
    immunodeficiency virus (HIV)
    13.Has known active infection with hepatitis B virus or hepatitis C virus
    •Note - Subjects with a history of hepatitis B or C with normal ALT and
    undetectable HBV DNA or HCV RNA are eligible for this study
    14.Has had a symptomatic venous thrombosis within the 2 weeks prior
    to study enrollment.
    NOTE: Subjects with a history of a deep vein thrombosis > 2 weeks prior
    to study enrollment who are on anticoagulation therapy with low
    molecular weight heparin are eligible for this study.
    15. For subjects with CNS involvement (primary tumor or metastatic
    disease): Have any active bleeding, or new intratumoral hemorrhage of
    more than punctate size on screening MRI obtained within 14 days of
    starting study drug or known bleeding diathesis or treatment with antiplatelet
    or anti-thrombotic agents
    16.Has known hypersensitivity to any of the components of tazemetostat
    or other inhibitor(s) of EZH2
    17.Is unable to take oral medications, malabsorption syndrome or any
    other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea or
    vomiting) that might impair the bioavailability of tazemetostat
    18.Has an uncontrolled intercurrent illness including, but not limited to,
    uncontrolled infection, or psychiatric illness/social situations that would
    limit compliance with study requirements.
    19.For female subjects of childbearing potential: Is pregnant or nursing
    20.For male subjects: Is unwilling to adhere to contraception criteria
    from time of enrollment in study to at least 30 days after last dose of
    tazemetostat.
    E.5 End points
    E.5.1Primary end point(s)
    - Cohorts 1 , 3, 4, 5 and 7 ORR (confirmed CR+PR) for tazemetostat in subjects with INI1-negative tumors using disease-appropriate standardized response criteria (primary CNS tumors: Response Assessment for Neuro-Oncology [RANO] and all others: RECIST 1.1).
    -Cohort 2: PFS rate after 16 weeks of treatment with tazemetostat. This is the number of subjects with CR, PR, or stable disease (SD) at the Week 16 assessment.
    - Cohort 6: Assessment of pre- and post-dose biopsies for immune priming (e.g., PD-L1 and CD8 IHC);
    - Cohort 8: Assessment of safety and tolerability of tazemetostat following 1600 mg oral administration QD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Cohorts 1 (rhabdoid tumors), 3 (other INI1-negative tumors), 4 (renal medullary carcinoma) and 5 (epithelioid sarcoma) and 7- ORR: every 8 weeks for tumor response until disease progression;
    - Cohort 2 (synovial sarcoma) – PFS: every 8 weeks until disease progression
    - Cohort 6 pre-and post-dose biopsies;
    - Cohort 8 assessment of AEs and clinical laboratory tests.
    E.5.2Secondary end point(s)
    - Duration of response for each cohort and for Cohorts 1, 3, 4, 5, 6, and 7 combined. Duration of response, for the subset of subjects with a confirmed CR or PR, is defined as the time from the first documented evidence of CR or PR to the time of first documented disease progression or death due to any cause, using disease-appropriate standardized response criteria;
    - Cohorts 5, 6 and 8: Disease control rate (DCR) for tazemetostat. This is defined as the number of subjects who achieve confirmed response (CR+PR) or who have SD lasting at least 32 weeks;
    - Cohorts 2, 6 and 8: ORR (confirmed CR+PR, RECIST 1.1) for tazemetostat;
    - PFS at Weeks 24, 32, and 56 and overall for each cohort. PFS is defined as the time from date of first dose of study treatment to the earlier of the date of first documented disease progression or date of death due to any cause;
    - OS at Weeks 24, 32, and 56 and overall for each cohort. OS is defined as the time from the date of the first dose of study treatment to the date of death due to any cause;
    Cohorts 1-7: Safety and tolerability of of orally administered tazemetostat 800 mg BID;
    - Population PK parameters for tazemetostat including, but not limited to: oral clearance (CL/F), oral volume of distribution (Vd/F), and first-order absorption rate constant (Ka), AUC and CMAX, and apparent half-life;
    - PD effects of tazemetostat in tumor tissue in IHC assessments of changes in the level of H3K27me3 following tazemetostat dosing.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cohort 2 (synovial sarcoma) – ORR: every 8 weeks until disease progression
    All Cohorts -
    •PFS: every 8 weeks until disease progression and analyzed at 24 and 56 weeks. OS: continuously throughout the treatment period and then every 16 weeks until death or study completion
    •Response duration: every 8 weeks from the time of confirmed response (CR or PR) until disease progression or death.
    •Safety: At each visit or required timepoint during treatment and until for 30 days after last treatment or until new anti-cancer therapy
    •PK: Days 1, 15, 29, 43 and 57
    •PD: Any time after week 8
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    France
    Germany
    Italy
    Taiwan
    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 the study will occur when the last subject completes the follow-up period or if 80% of enrolled subjects are decreased prior to the collection of the last survival follow-up.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 257
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 266
    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)
    Subjects will be followed for safety for approximately 30 days after the last dose of tazemetostat. For subjects that discontinue dosing, participation will continue for survival follow-up and response for 2 years from first dose of tazemetostat.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-21
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