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A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02601937
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Epizyme, Inc.

Brief Summary:

This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study.

The study has two parts: Dose Escalation and Dose Expansion.

Dose escalation for subjects with the following relapsed/refractory malignancies:

  • Rhabdoid tumors:
  • Atypical teratoid rhabdoid tumor (ATRT)
  • Malignant rhabdoid tumor (MRT)
  • Rhabdoid tumor of kidney (RTK)
  • Selected tumors with rhabdoid features
  • INI1-negative tumors:
  • Epithelioid sarcoma
  • Epithelioid malignant peripheral nerve sheath tumor
  • Extraskeletal myxoid chondrosarcoma
  • Myoepithelial carcinoma
  • Renal medullary carcinoma
  • Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor approval)
  • Synovial Sarcoma with a SS18-SSX rearrangement

Dose Expansion at the MTD or the RP2D

  • Cohort 1 -(closed to enrollment) ATRT
  • Cohort 2 - MRT/RTK/selected tumors with rhabdoid features
  • Cohort 3 - INI-negative tumors:

    • Epithelioid sarcoma
    • Epithelioid malignant peripheral nerve sheath tumor
    • Extraskeletal myxoid chondrosarcoma
    • Myoepithelial carcinoma
    • Renal medullary carcinoma
    • Chordoma (poorly differentiated or de-differentiated)
    • Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor approval
  • Cohort 4 -(closed to enrollment) Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement

Condition or disease Intervention/treatment Phase
Rhabdoid Tumors INI1-negative Tumors Synovial Sarcoma Malignant Rhabdoid Tumor of Ovary Drug: Tazemetostat Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Study Start Date : January 7, 2016
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : November 2022


Arm Intervention/treatment
Experimental: Open-label Tazemetostat

Dose Escalation: Level 1 (Starting Dose) Oral Tazemetostat 240 mg/m^2 BID; Level 2 Oral Tazemetostat 300 mg/m^2 BID; Level 3 Oral Tazemetostat 400 mg/m^2 BID; Level 4 Oral Tazemetostat 520 mg/m^2 BID; Level 5 Oral Tazemetostat 700 mg/m^2 BID; Level 6 Oral Tazemetostat 900 mg/m^2 BID; Level 7 Oral Tazemetostat 1200 mg/m^2 BID

Dose Expansion:

Cohort 1: Oral tazemetostat 1200mg/m2 BID Cohort 2: Oral tazemetostat 520mg/m2 BID Cohort 3: Oral tazemetostat 520mg/m2 BID Cohort 4: Oral tazemetostat 800mg/m2 TID (2400mg/m2/day)

Drug: Tazemetostat
Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.
Other Names:
  • EPZ-6438
  • E7438




Primary Outcome Measures :
  1. To determine the MTD or the RP2D (Dose Escalation) [ Time Frame: 1 cycle/28 days ]
    The incidence and severity of treatment-emergent adverse events (AEs) qualifying as protocol-defined DLTs in Cycle 1 will guide establishment of the protocol defined RP2D and/or MTD

  2. Dose expansion: Number of subjects with objective response using disease appropriate standardized response criteria [ Time Frame: Assessed every 8 weeks for duration of study participation which is estimated to be 24 months ]

Secondary Outcome Measures :
  1. Dose escalation: Number of subjects with objective response using disease appropriate standardized response criteria [ Time Frame: Assessed every 8 weeks for duration of study participation which is estimated to be 24 months ]
  2. Dose Expansion: Progression-free survival (PFS) [ Time Frame: At 24 and 56 weeks post treatment using Kaplan-Meier method ]
  3. Dose Expansion: Overall Survival (OS) [ Time Frame: At 24 and 56 weeks post treatment using Kaplan-Meier method ]
  4. Incidence of treatment-emergent adverse events as a measure of safety and tolerability [ Time Frame: Adverse events assessed from first dose through 30 days post last dose ]
  5. Pharmacokinetics profile of tazemetostat and its metabolite (plasma): Cmax [ Time Frame: Days 1 and 15 ]
  6. Pharmacokinetics profile of tazemetostat and its metabolite (plasma): Tmax [ Time Frame: Days 1 and 15 ]
  7. Pharmacokinetics profile of tazemetostat and its metabolite (plasma): AUC(0-t) [ Time Frame: Days 1 and 15 ]
  8. Pharmacokinetics profile of tazemetostat and its metabolite (plasma): AUC(0-12) [ Time Frame: Days 1 and 15 ]
  9. Pharmacokinetics profile of tazemetostat and its metabolite (plasma): t1/2 [ Time Frame: Days 1 and 15 ]
  10. Pharmacokinetics profile of tazemetostat and its metabolite (plasma): CL/F [ Time Frame: Day 15 ]
  11. Pharmacokinetics profile of tazemetostat and its metabolite (plasma): Vd/F [ Time Frame: Day 15 ]
  12. Pharmacokinetics profile of tazemetostat and its metabolite (plasma): Ka [ Time Frame: Day 15 ]
  13. Pharmacokinetics profile of tazemetostat and its metabolite (plasma): Ctrough [ Time Frame: Day 1 of cycles 2, 3 and 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age (at the time of consent/assent): ≥6 months to <18 years

    - Cohort 4 only: ≥10 years to <18 years

  2. Performance Status:

    • If <12 years of age: Lanksy Performance Status >50%
    • If ≥12 years of age: Karnofsky Performance Status >50% 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/assent
  4. Has a life expectancy of >3 months
  5. Has relapsed or refractory disease and no standard treatment options as determined by locally or regionally available standards of care and treating physician's discretion
  6. Is ineligible or inappropriate for other treatment regimens known to have effective potential
  7. Has a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) or equivalent laboratory certification
  8. 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
  9. Has completed a prior therapy (ies) according to the criteria below:

    • Other investigational study agent (any medicinal product that is not approved in the country of treatment for any indication, adult or pediatric) (At least 30 days or five half-lives, whichever is longer, since last dose prior to the first dose of tazemetostat)
    • Chemotherapy: cytotoxic (At least 14 days since last dose of chemotherapy prior to first dose of tazemetostat)
    • Chemotherapy: nitrosoureas (At least 6 weeks since last dose of nitrosoureas prior to first dose of tazemetostat)
    • Chemotherapy: non-cytotoxic (e.g., small molecule inhibitor) (At least 14 days since last dose of non-cytotoxic chemotherapy prior to first dose of tazemetostat)
    • Monoclonal antibody (ies) (At least 28 days since the last dose of any monoclonal antibody prior to first dose of tazemetostat)
    • Immunotherapy (e.g., tumor vaccine) At least 6 weeks since last dose of immunotherapy agent(s) prior to first dose of tazemetostat)
    • Radiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat/At least 21 days from stereotactic radiosurgery prior to first dose of tazemetostat/At least 12 weeks from craniospinal, ≥ 50% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)
    • Hematopoietic growth factor (At least 14 days from last dose of hematopoietic growth factor prior to first dose of tazemetostat)
    • Hematopoietic cell transplantation (At least 60 days from infusion of hematopoietic cells prior to first dose of tazemetostat)
  10. Has adequate hematologic (bone marrow and coagulation factors), renal and hepatic function as defined by criteria below:

    • Hematologic (BM Function):

      • Hemoglobin ≥ 8 g/dL
      • Platelets ≥100,000/mm^3 (≥100 x 10^9/L)
      • ANC ≥1,000/mm^3 (≥1.0 x 10^9/L)
    • Hematologic (Coagulation Factors):

      • INR/ PTd ≤1.5 ULN
      • PTT ≤1.5 ULN
      • Fibrinogen ≥0.75 LLN
    • Renal Function (creatinine clearance or serum creatinine):

      • Calculated creatinine clearance ≥50 mL/min/1.73m^2
      • Serum creatinine 6 months to 1 year: male 0.6 mg/dL (53 µmol/L) female 0.5 mg/dL (44 µmol/L)
      • Serum creatinine 1 to < 2 years: male 0.6 mg/dL (53 µmol/L) female 0.6 mg/dL (53 µmol/L)
      • Serum creatinine 2 to < 6 years: male 0.8 mg/dL (71 µmol/L) female 0.8 mg/dL (71 µmol/L)
      • Serum creatinine 6 to <10 years: male 1 mg/dL (88 µmol/L) female 1 mg/dL (88 µmol/L)
      • Serum creatinine 10 to <13 years: male 1.2 mg/dL (106 µmol/L) female 1.2 mg/dL (106 µmol/L)
      • Serum creatinine 13 to <16 years: male 1.5 mg/dL (133 µmol/L) female 1.4 mg/dL (125 µmol/L)
      • Serum creatinine ≥16 years: male 1.7 mg/dL (150 µmol/L) female 1.4 mg/dL (125 µmol/L)
    • Hepatic Function:

      • Total bilirubin <1.5 x ULN
      • ALT or AST <3 x ULN Eligibility can be determined by either total or conjugated bilirubin
  11. For subjects with CNS involvement: Subjects must have deficits that are stable for a minimum of 14 days prior to enrollment, or seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of 7 days prior to enrollment

    NOTE: Subjects with leptomeningeal disease or brian tumors with positive cerebral spinal fluid cytology are eligible for this study. Subjects may receive glucocorticoids (at stable or tapering dose) to control CNS symptoms prior to enrollment; however, subjects should receive a stable or tapering dose for at least 7 days prior to enrollment.

  12. Has a shortening fraction of >27% or an ejection fraction of ≥50% by echocardiogram or multi-gated acquisition scan and New York Heart Association Class<2
  13. Has a QT interval corrected by Fridericia's formula (QTcF) ≤450 msec
  14. Is able to swallow and retain orally administered medication and does not have any uncontrolled gastrointestinal (GI) condition such as nausea, vomiting, or diarrhea, or any clinically significant GI abnormalities that may alter absorption such as malabsorption syndromes, hereditary fructose intolerance, glucose-galactose malabsorption, sucrose-isomaltase insufficiency, or major resection of stomach and/or bowels NOTE: Nasogastric and gastrostomy tube administration of the oral suspension formulation of study drug is permitted.
  15. Has sufficient tumor tissue (slides or blocks) available for central confirmatory testing of immunohistochemistry and/or cytogenetics/fluorescence in situ hybridization (FISH) and/or deoxyribonucleic acid mutation analysis (required for study entry but enrollment based on local results)
  16. Is willing and able to comply with all aspects of the protocol as judged by Investigator
  17. For female subjects of childbearing potential: Subject must:

    • Have a negative beta-human chorionic gonadotropin (β-hCG) pregnancy test at time of Screening and within 72 hours 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 Section 8.6.11 start of Screening until 6 months following the last dose of study treatment 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 8.6.11, or
    • Have a male partner who is vasectomized with confirmed azoospermia
  18. For male subjects with a female partner of childbearing potential: Subject must:

    • Be vasectomized or
    • Agree to use condoms as defined in Section 8.5.11 from first dose of tazemetostat until 3 months following the last dose of tazemetostat, or
    • Have a female partner who is NOT of childbearing potential

For Dose Escalation Only:

To be eligible for enrollment in dose escalation, a subject must meet ALL of the following criteria in addition to the inclusion criteria listed above for all subjects:

  1. Has evaluable disease as defined as lesions that can be accurately measured at least in one dimension by radiographic examination or physical examination and other lesions such as bone lesions, leptomeningeal disease, ascites, hepatosplenomegaly from disease.
  2. Has one of the following histologically confirmed tumors: (NOTE: Evidence of diagnostic pathology of original biopsy confirmed by a CLIA/CAP certified laboratory must be available)

    • Rhabdoid tumor:

      • ATRT (Closed to enrollment)
      • MRT
      • RTK
      • Selected tumors with rhabdoid features
    • NI1-negative tumor:

      • Epithelioid sarcoma
      • Epithelioid malignant peripheral nerve sheath tumor
      • Extraskeletal myxoid chondrosarcoma
      • Myoepithelial carcinoma
      • Renal medullary carcinoma
      • Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor approval
    • Synovial sarcoma with SS18-SSX rearrangement (NOTE: Evidence of diagnostic pathology of original biopsy confirmed by a CLIA/CAP certified laboratory must be available) (Closed to enrollment)
  3. For subjects with ATRT, MRT, RTK, or selected tumors with rhabdoid features only: the following test results must be available: Morphology and immunophenotypic panel consistent with rhabdoid tumor and Loss of INI1 or SMARCA4 confirmed by IHC, or Molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss/mutation when INI1 or SMARCA4 IHC is equivocal or unavailable
  4. For subjects with INI1 negative tumor only:

    the following test results must be available: Morphology and immunophenotypic panel consistent with INI1-negative tumors, and Loss of INI1 confirmed by IHC, or Molecular confirmation of tumor bi-allelic INI1 loss/mutation when INI1 IHC is equivocal or unavailable

  5. For subjects with synovial sarcoma only:

The following test results must be available:

Morphology consistent with synovial sarcoma, and Cytogenetics or FISH and/or molecular confirmation (e.g., DNA sequencing) of SS18 rearrangement t(X;18)(p11;q11)

For Dose Expansion Only:

Note: To be eligible for enrollment in Dose Expansion, a subject must meet ALL of the following criteria in addition to the inclusion criteria for ALL subjects listed above

  1. Has measurable disease
  2. Has one of the following histologically confirmed tumors:

    • Cohort 1 - ATRT (Closed to enrollment)
    • Cohort 2 - MRT/RTK/selected tumors with rhabdoid features
    • Cohort 3 - INI-negative tumors:

      • Epithelioid sarcoma
      • Epithelioid malignant peripheral nerve sheath tumor
      • Extraskeletal myxoid chondrosarcoma(EMC)
      • Myoepithelial carcinoma
      • Renal medullary carcinoma
      • Chordoma (poorly differentiated or de-differentiated)
      • Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor approval
    • Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement (Closed to enrollment) NOTE: Evidence of diagnostic pathology of original biopsy confirmed by a CLIA/CAP or other Sponsor-approved certified laboratory must be available.
  3. For subjects with ATRT/MRT/RTK only - have the following test results available:

    • Morphology and immunophenotypic panel consistent with rhabdoid tumor, and
    • Loss of INI1 or SMARCA4 confirmed by IHC, or
    • Molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss/mutation when INI1 or SMARCA4 IHC is equivocal or unavailable
  4. For subjects with INI1-negative tumors only: The following test results must be available:

    • Morphology and immunophenotypic panel consistent with INI1-negative tumors, and
    • Loss of INI1 confirmed by IHC, or
    • Molecular confirmation of tumor bi-allelic INI1 loss/mutation when INI1 IHC is equivocal or unavailable
  5. For subjects with synovial sarcoma with SS18-SSX rearrangement (in Cohort 4 ONLY - Closed to enrollment): The following test results must be available:

    • Morphology consistent with synovial sarcoma, and
    • Cytogenetics or FISH and/or molecular confirmation (e.g., deoxyribonucleic acid [DNA] sequencing) of SS18 rearrangement t(X;18)(p11;q11)
  6. For subjects to be enrolled in Cohort 4 (Closed to enrollment): Able to swallow and retain orally administered tablets

Exclusion Criteria:

  1. Has had prior exposure to tazemetostat or other inhibitor(s) of EZH2
  2. Is being actively treated for another concurrent malignancy or is less than five years from completion of treatment for another malignancy
  3. 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
  4. Has had major surgery within 2 weeks prior to enrollment NOTE: Minor surgery (e.g., minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 2 weeks prior to enrollment.
  5. 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 lab at screening. Cytogenetic testing and DNA sequencing will be conducted following an abnormal result of bone marrow aspirate/biopsy.

  6. Has a prior history of T-LBL/T-ALL.
  7. Has clinically active heart disease including prolonged corrected QTcF (>450 msec)
  8. Is currently taking any prohibited medication(s) as described in Section 7.3.
  9. 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
  10. Has an active infection requiring systemic treatment
  11. Is immunocompromised (i.e. congenital immunodeficiencies), including subjects known history of infection with human immunodeficiency virus (HIV)
  12. Has known history of chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (detectable HCV RNA)
  13. Has had a symptomatic venous thrombosis within the 14 days prior to study enrollment NOTE: Subjects with a history of a deep vein thrombosis 14 days prior to study enrollment who are on anticoagulation therapy with low molecular weight heparin are eligible for this study
  14. 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 anti-platelet or anti-thrombotic agents 15.15. Has known hypersensitivity to any of the components of tazemetostat or other inhibitor(s) of EZH2, or hypersensitivity to Ora-sweet or methylparaben

16. Has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements 17. For female subjects of childbearing potential: Is pregnant or nursing 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601937


Contacts
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Contact: Shefali Agarwal, MD 855-500-1011 clinicaltrials@epizyme.com

Locations
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United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Jasmine Pauly       jpauly@chla.usc.edu   
Principal Investigator: Ashley Margol, MD         
University of California San Francisco - Benioff Children's Hospital Recruiting
San Francisco, California, United States, 94158
Contact: Stephanie Schwartz       Stephanie.Schwartz@ucsf.edu   
Principal Investigator: Kieuhoa Vo, MD         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Debra Schissel         
Contact       debra.schissel@childrenscolorado.org   
Principal Investigator: Margaret Macy, MD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kaitlin Hardy       kahardy@childrensnational.org   
Principal Investigator: Lindsay Kilburn, MD         
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kate Glasscox       AflacDevTreferral@choa.org   
Principal Investigator: Dolly Aguilera, MD         
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Laura Kane       lakane@luriechildrens.org   
Principal Investigator: Stewart Goldman, MD         
United States, Maryland
John Hopkins Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Michele-Corrine Ako       mako1@jhmi.edu   
Principal Investigator: Christine Pratilas, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Suzanne Ezrre, RN       sezrre@partners.org   
Principal Investigator: Susan Chi, MD         
Massachusetts General Hospital - Cancer Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: David Ebb, MD         
United States, New York
Memorial Sloan Kettering Recruiting
New York, New York, United States, 10065
Contact: Jennifer DiRenzo       Direnzoj@mskcc.org   
Principal Investigator: Neerav Shukla, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Lori Backus       Lori.backus@cchmc.org   
Principal Investigator: Maryam Fouladi, MD         
United States, Oregon
Oregon Health & Science University (OHSU) Recruiting
Portland, Oregon, United States, 97239
Contact: Ailien Truong       truonga@ohsu.edu   
Principal Investigator: Kellie Nazemi, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joseph Gottschalk       gottschalj@email.chop.edu   
Principal Investigator: Frank Balis, MD         
United States, Tennessee
St. Jude Children's Research Hospital, Inc Completed
Memphis, Tennessee, United States, 38105
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Alison Patterson       alison.patterson@childrens.com   
Principal Investigator: Ted Laetsch, MD         
Texas Children's Cancer and Hematology Center Recruiting
Houston, Texas, United States, 77098
Contact: Renee Klenke       raklenke@txch.org   
Principal Investigator: Joanna Yi, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Christine Goetz       Christine.Goetz@seattlechildrens.org   
Principal Investigator: Navin Pinto, MD         
Australia, New South Wales
Sydney Children's Hospital Recruiting
Sydney, New South Wales, Australia, 2031
Contact: Jade Poll       jade.poll@health.nsw.gov.au   
Principal Investigator: David Ziegler, MD         
Australia, Queensland
Lady Cilento Children's Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Natasha Brown       natasha.brown@health.qld.gov.au   
Principal Investigator: Tim Hassall, MD         
Australia, Victoria
The Royal Children's Hospital Recruiting
Melbourne, Victoria, Australia, 3052
Contact: Ryan Hehir       ryan.hehir@mcri.edu.au   
Principal Investigator: Michael Sullivan, MD         
Australia
The Childrens Hospital at Westmead Oncology Unit Recruiting
Westmead, Australia, 2145
Principal Investigator: Geoffrey McCowage         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Gina Lee       ginaj.lee@sickkids.ca   
Principal Investigator: Abha Gupta, MD         
Denmark
Rigshospitalet Department of Oncology Blegdamsvej Recruiting
Copenhagen, Denmark, 2100
Contact: Merete Matz       merete.matz@regionh.dk   
Principal Investigator: Karsten Nysom, MD         
France
Institut Curie Recruiting
Paris, France, 75248
Contact: Soraya Dib       soraya.dib@curie.fr   
Principal Investigator: Franck Bourdeaut, MD         
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Laurence Tartier       Laurence.TARTIER@gustaveroussy.fr   
Principal Investigator: Birgit Geoerger, MD         
Germany
Children's Hospital Augsburg Klinikum Recruiting
Augsburg, Germany, 86156
Contact: Marianne Pichlmair       marianne.pichlmair@klinikum-augsburg.de   
Principal Investigator: Michael Fruhwald, MD         
Charite - Universitatsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Bettina Geithner       bettina.geithner@charite.de   
Principal Investigator: Hernaiz Driever, MD         
Universitaetsklinikum Heidelberg - Zentrum fur Kinder- und Jugendmedizin Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Olaf Witt, MD         
Westfalische Wilhelms - Universitat Munster Padiatrische Recruiting
Munster, Germany, 48149
Contact: Inta Hartmanis       hartmai@ukmuenster.de   
Principal Investigator: Kornelius Kerl, MD         
Italy
Istituto Giannina Gaslini- UOSD Centro di Neuro-Oncologia Recruiting
Genova, Italy, 16147
Contact: Sabrina Zanardi       SabrinaZanardi@gaslini.org   
Principal Investigator: Maria Luisa Garre, MD         
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
Contact: Elena Barzano       elena.barzano@istitutotumori.mi.it   
Principal Investigator: Michela Casanova, MD         
Netherlands
Erasmus MC - Sophia Children's Hospital Completed
Rotterdam, Netherlands, 3015
Prinses Maxima Centrum voor Kinderoncologie Recruiting
Utrecht, Netherlands, 3584 EA
Contact: Margo Geerdink       m.geerdink-3@prinsesmaximacentrum.nl   
Principal Investigator: Jasper van der Lugt, MD         
United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust Recruiting
London, United Kingdom, WC1N 3JH
Contact: Omolola Famakinwa       Omolola.Famakinwa@gosh.nhs.uk   
Principal Investigator: Darren Hargrave, MD         
Central Manchester University Hospital - Royal Manchester Children's Hospital Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Emma Charnock       emma.charnock@cmft.nhs.uk   
Principal Investigator: Guy Makin, MD         
Sponsors and Collaborators
Epizyme, Inc.
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Responsible Party: Epizyme, Inc.
ClinicalTrials.gov Identifier: NCT02601937    
Other Study ID Numbers: EZH-102
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Synovial
Rhabdoid Tumor
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Complex and Mixed