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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02601950




Registration number
NCT02601950
Ethics application status
Date submitted
21/10/2015
Date registered
11/11/2015
Date last updated
3/04/2020

Titles & IDs
Public title
A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma
Scientific title
A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma
Secondary ID [1] 0 0
EZH-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Rhabdoid Tumors (MRT) 0 0
Rhabdoid Tumors of the Kidney (RTK) 0 0
Atypical Teratoid Rhabdoid Tumors (ATRT) 0 0
Selected Tumors With Rhabdoid Features 0 0
Synovial Sarcoma 0 0
INI1-negative Tumors 0 0
Malignant Rhabdoid Tumor of Ovary 0 0
Renal Medullary Carcinoma 0 0
Epithelioid Sarcoma 0 0
Poorly Differentiated Chordoma (or Other Chordoma With Sponsor Approval) 0 0
Any Solid Tumor With an EZH2 GOF Mutation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tazemetostat

Experimental: Open-label Tazemetostat - All Cohorts [Cohort 1 - MRT, RTK, ATRT, or tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type [SCCOHT], also known as malignant rhaboid tumor of the ovary [MRTO] Cohort 2 - Relapsed/refractory synovial sarcoma (SS18-SSX rea), Cohort 3 - Other INI1-negative tumors or any solid tumor with an EZH2 GOF mutation, Cohort 4 - Renal medullary carcinoma, Cohort 5 - Epithelioid sarcoma, Cohort 6 - Epithelioid sarcoma undergoing mandatory tumor biopsy and Cohort 7 - Poorly differentiated chordoma (or other chordoma with Sponsor approval)] will receive 800 mg oral Tazemetostat BID x 28 days


Treatment: Drugs: Tazemetostat
Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with objective response using disease appropriate standardized response criteria
Timepoint [1] 0 0
Assessed every 8 weeks for duration of study participation which is estimated to be 24 months
Primary outcome [2] 0 0
Progression-free survival (PFS) rate for Cohort 2 (Relapsed/Refractory Synovial Sarcoma) - The number of subjects with CR, PR, or stable disease (SD) at 16 week assessment
Timepoint [2] 0 0
16 weeks of treatment
Primary outcome [3] 0 0
Assess the effects of tazemetostat on tumor immune priming for Cohort 6
Timepoint [3] 0 0
Through study completion, an average of 2 years
Primary outcome [4] 0 0
Assess the safety and tolerability of tazemetostat 1600 mg QD for Cohort 8
Timepoint [4] 0 0
Through study completion, an average of 2 years
Secondary outcome [1] 0 0
Duration of response in subjects in Cohorts 1, 2, 3, 4, 5, 6 and 7 and in Cohorts 1, 3, 4, 5, 6 and 7 combined for subjects achieving a complete response (CR) and partial response (PR) following oral administration of tazemetostat 800 mg BID
Timepoint [1] 0 0
Assess every 8 weeks for duration of study participation which is estimated to be 24 months
Secondary outcome [2] 0 0
Disease control rate (DCR) in subjects with epithelioid sarcoma (Cohort 5) and epithelioid sarcoma undergoing mandatory biopsy (Cohort 6) following oral administration of tazemetostat 800 mg BID - The number of subjects with confirmed CR, PR or SD at 32 week assessment
Timepoint [2] 0 0
32 weeks of treatment
Secondary outcome [3] 0 0
Overall response rate ORR for Cohort 2 (relapsed/refractory synovial sarcoma) and Cohort 6 (epithelioid sarcoma undergoing mandatory biopsy) following oral administration of tazemetostat 800 mg BID - ORR (confirmed CR+PR, RECIST 1.1)
Timepoint [3] 0 0
Assessed every 8 weeks for duration of study participation which is estimated to be 24 months
Secondary outcome [4] 0 0
PFS for each cohort - 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
Timepoint [4] 0 0
24, 32 and 56 weeks of treatment
Secondary outcome [5] 0 0
OS for each cohort - The time from the date of the first dose of study treatment to the date of death due to any cause
Timepoint [5] 0 0
24, 32 and 56 weeks of treatment
Secondary outcome [6] 0 0
Incidence of treatment-emergent adverse events as a measure of safety and tolerability
Timepoint [6] 0 0
Adverse events assessed from first dose through 30 days post last dose
Secondary outcome [7] 0 0
Pharmacokinetics profile of tazemetotstat and its metabolite (plasma): Cmax
Timepoint [7] 0 0
Days 1 and 15
Secondary outcome [8] 0 0
Pharmacokinetics profile of tazemetotstat and its metabolite (plasma): Tmax
Timepoint [8] 0 0
Days 1 and 15
Secondary outcome [9] 0 0
Pharmacokinetics profile of tazemetotstat and its metabolite (plasma): AUC(0-t)
Timepoint [9] 0 0
Days 1 and 15
Secondary outcome [10] 0 0
Pharmacokinetics profile of tazemetotstat and its metabolite (plasma): AUC(0-12)
Timepoint [10] 0 0
Days 1 and 15
Secondary outcome [11] 0 0
Pharmacokinetics profile of tazemetotstat and its metabolite (plasma): t1/2
Timepoint [11] 0 0
Days 1 and 15
Secondary outcome [12] 0 0
Pharmacokinetics profile of tazemetotstat and its metabolite (plasma): CL/F
Timepoint [12] 0 0
Days 1, 15, 29, 43, and 57
Secondary outcome [13] 0 0
Pharmacokinetics profile of tazemetotstat and its metabolite (plasma): Vd/F
Timepoint [13] 0 0
Days 1, 15, 29, 43, and 57
Secondary outcome [14] 0 0
Pharmacokinetics profile of tazemetotstat and its metabolite (plasma): Ka
Timepoint [14] 0 0
Days 1, 15, 29, 43, and 57
Secondary outcome [15] 0 0
Pharmacokinetics profile of tazemetotstat and its metabolite (plasma): Ctrough
Timepoint [15] 0 0
Days 29, 43 and 57
Secondary outcome [16] 0 0
Investigate the pharmacodynamics (PD) effects of tazemetostat in tumor tissue - IHC assessments of changes in the level of H3K27-Me3 following tazemetostat dosing
Timepoint [16] 0 0
At week 8
Secondary outcome [17] 0 0
Duration of response in subjects with epithelioid sarcoma in Cohort 8 at 1600 mg QD.
Timepoint [17] 0 0
Assess every 8 weeks for duration of study participation which is estimated to be 24 months
Secondary outcome [18] 0 0
Disease control rate (DCR) in subjects with epithelioid sarcoma (Cohort 8) following oral administration of tazemetostat 1600 mg QD - The number of subjects with confirmed CR, PR or SD at 32 week assessment
Timepoint [18] 0 0
32 weeks of treatment
Secondary outcome [19] 0 0
Overall response rate ORR for subjects with epithelioid sarcoma (Cohort 8) following oral administration of tazemetostat 1600 mg QD - ORR (confirmed CR+PR, RECIST 1.1)
Timepoint [19] 0 0
Assessed every 8 weeks for duration of study participation which is estimated to be 24 months

Eligibility
Key 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 and 5)

- That is relapsed or refractory after treatment with an approved therapy(ies),
defined as metastatic or non-resectable, locally advanced disease that has
previously been treated with and progressed following approved therapy(ies)
(Cohort 2)

- That has progressed within 6 months prior to study enrollment (Cohort 5
Expansion, Cohort 6 and Cohort 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
equivalent laboratory certification

7. For Cohort 1 (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
tests must be available by local laboratory: Morphology consistent with synovial
sarcomas, 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/aberrant tumors 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 optional tumor biopsy):

- Morphology and immunophenotypic panel consistent with epithelioid sarcoma (e.g.,
CD34, EMA, Keratin, and INI1)

- If providing optional biopsy: 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 4.0.3 or are
clinically stable and not clinically significant, at time of enrollment.

12. Prior anti-cancer therapy(ies), if applicable, must be completed according to the
criteria below:

- 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 42 days 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 stereostatic 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)

- High dose therapy with autologous hematopoietic cell infusion (At least 60 days
from last infusion 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)

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

15. Has adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic
function as defined by criteria below:

- Hematologic (BM Function):

- Hemoglobin =9 mg/dL

- Platelets =100,000/mm^3 (=100x10^9/L)

- ANC =1,000/mm^3 (=1.0x10^9/L)

- Hematologic (Coagulation Factors):

- INR/PT? <1.5 ULN

- PTT>1.5 ULN

- Renal Function:

- Serum creatinine =1.5 x ULN

- Hepatic Function:

- Total bilirubin <1.5 x ULN(Eligibility can be determined by conjugated or
total bilirubin)

- AST and ALT <3 x ULN NOTE: Laboratory results obtained during screening
should be used to determine eligibility criteria. In situations where
laboratory results are outside the permitted range, the Investigator may
retest the subject and the subsequent within range screening result may be
used to determine the subject's eligibility.

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
NOTE: 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 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 =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 (ß-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 Section 8.6.1, from a minimum
of 7 days prior to first dose until 6 months following the last dose of
tazemetostat 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 8.6.1), 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 as defined in Section 8.6.2, 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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: A
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 re-vision)
is permitted 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)

11. Has an active infection requiring systemic treatment

12. Is immunocompromised (i.e. has congenital 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 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 punctuate size of
screening MRI obtained within 14 days of starting study drug or known bleeding
diathesis or treatment with anti-platelet or anti-thrombotic agents

16. Has known hypersensitivity to any of the component of tazemetostat or other
inhibitor(s)of EZH2

17. Is unable to take oral medications, or has a malabsorption syndrome or any
uncontrolled gastrointestinal condition (e.g., nausea, diarrhea or vomiting) that
would limit compliance with study requirements.

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 the study to at least 3 months after last dose of tazemetostat.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Metro South Hospital and Health Service via Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussels
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
France
State/province [18] 0 0
Bordeaux
Country [19] 0 0
France
State/province [19] 0 0
Lyon
Country [20] 0 0
France
State/province [20] 0 0
Paris Cedex 13
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
France
State/province [22] 0 0
Villejuif
Country [23] 0 0
Germany
State/province [23] 0 0
Augsburg
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Italy
State/province [25] 0 0
Milano
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei City
Country [27] 0 0
United Kingdom
State/province [27] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Epizyme, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg
BID (twice daily) and 1600 mg QD (once daily). Subjects will be screened for eligibility
within 21 days of the planned date of the first dose of tazemetostat and enrolled into one of
8 cohorts:

Cohort using tazemetostat 800 mg BID

- Cohort 1 (Closed for enrollment): MRT, RTK, ATRT, and selected tumors with rhabdoid
features, including small cell carcinoma of the ovary hypercalcemic type [SCCOHT], also
known as malignant rhaboid tumor of the ovary [MRTO]

- Cohort 2 (Closed for enrollment): Relapsed or refractory synovial sarcoma with SS18-SSX
rearrangement

- Cohort 3 (Closed for enrollment): Other INI1 negative tumors or any solid tumor with an
EZH2 gain of function (GOF) mutation, including: epithelioid malignant peripheral nerve
sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial
carcinoma, other INI1-negative malignant tumors with Sponsor approval (e.g.,
dedifferentiated chordoma) any solid tumor with an EZH2 GOF mutation including but not
limited to Ewing's sarcoma and melanoma

- Cohort 4 (Closed for enrollment): Renal medullary carcinoma (RMC)

- Cohort 5 (Closed for enrollment): Epithelioid sarcoma (ES)

- Cohort 6 (Opened for enrollment): Epithelioid sarcoma (ES) undergoing mandatory tumor
biopsy

- Cohort 7 (Opened for enrollment): Poorly differentiated chordoma (or other chordoma with
Sponsor approval)

Cohort using tazemetostat 1600 mg QD

• Cohort 8 (Opened for enrollment): Epitheliod sarcoma

Subjects will be dosed in continuous 28-day cycles. (Note: if treatment with study drug is
discontinued prior to completing 2 years, subjects will be followed for a maximum duration of
2 years from start of study drug dosing.) Response assessment will be performed every 8 weeks
while on study.

Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or
withdrawal of consent, or termination of the study.
Trial website
https://clinicaltrials.gov/show/NCT02601950
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shefali Agarwal, MD
Address 0 0
Country 0 0
Phone 0 0
855-500-1011
Fax 0 0
Email 0 0
clinicaltrials@epizyme.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02601950