ClinicalTrials.gg
Active, not recruitingNCT04917042Updated Jun 4, 2026Results posted

Tazemetostat in Malignant Peripheral Nerve Sheath Tumors

A Phase 2 interventional study of Tazemetostat in Peripheral Nerve Sheath Tumor, sponsored by University of Florida. Active, not recruiting at 1 site in United States. Open to participants aged 12 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Primary conditionNeurofibrosarcomaRegistry: Nerve Sheath NeoplasmsReclassifiedWhy we changed it
Registry
Nerve Sheath Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Neurofibrosarcoma
Why
  1. The study's title name Neurofibrosarcoma, a narrower term within Nerve Sheath Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Florida · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
12 Years to 99 Years
Sex
All
01

Study summary

This phase 2, open label, single arm study will investigate the use of tazemetostat in patients with recurrent/refractory and/or metastatic malignant peripheral nerve sheath tumors.

02

Conditions studied

  • Peripheral Nerve Sheath Tumor

Browse trials for

Keywords

  • metastatic malignant peripheral nerve sheath tumors
  • Enhancer of zeste homolog 2 (EZH2) inhibition
  • sarcoma
  • pediatric
  • tazemetostat
03

In context

Neurofibrosarcoma Reclassified

98 studies on the registry are indexed under Neurofibrosarcoma; 23 are open to participants now.

This study's enrollment of 10 is below the median of 46 across 84 interventional studies indexed under Neurofibrosarcoma.

Browse Neurofibrosarcoma studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Compared within Neurofibrosarcoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Nerve Sheath Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
12 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A histologic confirmation of recurrent/ and/or malignant peripheral nerve sheath tumor with (RECIST)
  • Patients ≥ 12 years of age at the time of enrollment
  • Performance status: 12-15 years old: Lansky > 50; 16-17 years old: > 50; ≥ 18 years old: Eastern Cooperative Group () score 0-2
  • Subjects must have adequately recovered from the acute toxic effects of all prior anti-cancer therapy per enrolling physician and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment.

    • Anti-cancer agents known to be Myelosuppressive: ≥ 28 days after the last dose of agent.
    • Anti-cancer agents not known to be myelosuppressive: > 7 days after the last dose of agent.
    • Antibodies: > 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade \< 1.
    • Systemic : if related to prior therapy > 14 days must have elapsed, or on stable dose for treatment of CNS disease.
    • Hematopoietic growth factors: > 14 days after the last dose of a long-acting growth factor.
    • Interleukins, Interferons, and Cytokines (other than hematopoietic growth factors): > 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors).
    • Radiation therapy (XRT)/External Beam Irradiation including Protons: > 14 days after local XRT; > 150 days after traumatic brain injury, craniospinal XRT or if radiation to > 50% of the pelvis; > 42 days if other substantial bone marow radiation.
    • Radiopharmaceutical therapy: > 42 days after systemically administered radiopharmaceutical therapy.
    • Major surgery > 14 days prior, with evidence of wound healing and no active surgical complications
  • Subjects must not have had prior exposure to Tazemetostat or other inhibitor(s) of EZH2
  • Adequate laboratory values of organ function, defined as:

    • Peripheral (ANC) > 1000/mm3.
    • count > 100,000/mm2 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
    • > 8.0 g/dL at baseline (may receive RBC transfusions).
    • or radioisotope > 70 ml/min/1.73 m2, or serum creatinine based on age/gender
    • Total \< 1.5 or direct bilirubin \< 1 x ULN.
    • (AST) and alanine aminotransferase (ALT) \< 2.5 x ULN; if liver metastases present, then AST and ALT must be \< 5 x ULN.
    • Serum albumin > 2 g/dL.
    • Coagulation \< 1.5, while on anti-coagulation INR \< 2.5.
  • Nervous system disorders ( v5.0) resulting from prior therapy must be \< Grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible.
  • Subjects must not have more than one active at the time of enrollment
  • Written obtained from the subject and the subject agrees to comply with all the study-related procedures. All subjects and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional standard practice.
  • Use of :

    • Women of (WOCBP) who are heterosexually active must be using two highly effective methods of contraception to avoid pregnancy throughout the study and for at least 6 months after the last dose of study drug to minimize the risk of pregnancy as Tazemetostat might counteract the effects of hormonal contraceptives. Birth control methods that can be used while in this study include: established use of oral, injected or implanted hormonal birth control or placement of an intrauterine device [IUD] or intrauterine system [IUS]. They or their partner must also use a second method, (e.g., condom with spermicidal foam/gel/film/cream/suppository or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository. If their male partner is vasectomized, they do not need to use any of the birth control methods listed above. The type of birth control they use must be discussed with the study doctor before beginning the study. The study doctor must approve the method you use before they can enter the study. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
    • Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms,vasectomy) throughout the study and should avoid donating sperm, for 90 days following the last dose of study drug.

Exclusion criteria

Exclusion Criteria:

  • Subjects who are currently taking the following concomitant medications:

    • Anti-cancer Agents: Subjects who are currently receiving other anti-cancer agents are not eligible.
    • Agents: Subjects who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 are prohibited from 14 days prior to the first dose of Tazemetostat to the end of the study. Note: Dexamethasone for CNS tumors or , on a stable dose, is allowed.
    • Grapefruit, grapefruit juice, Seville oranges and food/drinks containing them should be avoided one week before the first dose of the study intervention
  • Subjects who are acutely ill with an uncontrolled active infection on systemic anti-infective agents are not eligible.
  • Subjects with a prior history of T-cell lymphoblastic lymphoma/T-cell acute lymphoblastic leukemia, myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) or other myeloproliferative neoplasm (MPN).
  • Subjects who have any of the following underlying major cardiac issues or conditions:

    • Known prolongation or documentation
    • Documented (NYHA) Class III or IV congestive heart failure.
    • Myocardial infarction within 6 months prior to registration.
    • Unstable angina within 6 months prior to registration.
    • Symptomatic arrhythmia.
  • Subjects who in the opinion of the investigator may be high risk for treatment complications or unable to comply with the safety monitoring requirements of the study
  • Heterosexually active males or females of may not participate unless they have agreed to use two highly effective methods for the duration of study treatment as Tazemetostat might counteract the effects of hormonal contraceptives. Female subjects of should agree to remain abstinent or use adequate contraceptive methods for 6 months after the last dose of Tazemetostat. Male subjects should agree to remain abstinent or use adequate contraceptive methods, and agree to refrain from donating sperm, and for 90 days after the last dose of Tazemetostat.
  • Females who are pregnant or breastfeeding will not be entered on this study because there is currently no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal.
  • Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID-19 vaccine are allowed.
  • Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
  • Known to tazmetostat or any component of the formulation of tazemetostat
  • Inability to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazmetostat
Terms in these criteria, in plain language(26)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    tazemetostat

    Drug: Tazemetostat

Interventions

  • Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.

    Also known as: TAZVERIK

06

What researchers measure

Primary outcomes

  1. Objective Response Rate

    Assess the objective response rate, defined as the proportion of subjects who achieve either a complete response or partial response based on radiographic evaluation of treatment response via RECIST1.1. A complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.

    Time frame: 143 days

Secondary outcomes

  1. Progression Free Survival

    Determine the progression free survival, defined as the length of time from the date of start of treatment to the date of disease progression per RECIST 1.1 criteria. Per RECIST 1.1 criteria, disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.

    Time frame: 143 days

  2. Time to Progression

    Determine the time to progression, defined as the length of time from the start of treatment until disease progression by RECIST 1.1 criteria. Per RECIST 1.1 criteria, disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.

    Time frame: 143 days

  3. Clinical Benefit

    Determine the clinical benefit using the Numbered Pain Rating Scale. For this scale, the subject rates their pain on a scale of 0 to 10. Zero means "no pain," and 10 means "the worst possible pain." For each patient, the mean pain rating scale score was computed by adding all the non-missing scores the patient had and then taking the average.

    Time frame: 143 days

  4. Clinical Benefit Rate

    Assess the clinical benefit rate, defined as the proportion of subjects with complete or partial response or stable disease (by RECIST 1.1 criteria) lasting at least 4 months. Per RECiST 1.1 criteria, a complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Stable disease is defined as having neither sufficient shrinkage for a partial response nor sufficient increase for progressive disease, taking as reference the smallest sum diameters while on study.

    Time frame: 143 days

07

Results

Posted Feb 4, 2026

Participant flow

Participant flow — Overall Study
MilestoneTazemetostat
Started10
Completed9
Not completed1
Withdrew: Subject is still on long-term follow-up1

Outcome measures

PrimaryObjective Response Rate

Assess the objective response rate, defined as the proportion of subjects who achieve either a complete response or partial response based on radiographic evaluation of treatment response via RECIST1.1. A complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.

Time frame:
143 days
Reported as:
Number · percentage of participants
Objective Response Rate
percentage of participantsTazemetostat
Objective Response Rate0
SecondaryProgression Free Survival

Determine the progression free survival, defined as the length of time from the date of start of treatment to the date of disease progression per RECIST 1.1 criteria. Per RECIST 1.1 criteria, disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.

Time frame:
143 days
Reported as:
Median · months
Progression Free Survival
monthsTazemetostat
Progression Free Survival1.9 (1.2 to NA)
SecondaryTime to Progression

Determine the time to progression, defined as the length of time from the start of treatment until disease progression by RECIST 1.1 criteria. Per RECIST 1.1 criteria, disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.

Time frame:
143 days
Reported as:
Median · months
Time to Progression
monthsTazemetostat
Time to Progression1.9 (1.2 to NA)
SecondaryClinical Benefit

Determine the clinical benefit using the Numbered Pain Rating Scale. For this scale, the subject rates their pain on a scale of 0 to 10. Zero means "no pain," and 10 means "the worst possible pain." For each patient, the mean pain rating scale score was computed by adding all the non-missing scores the patient had and then taking the average.

Time frame:
143 days
Reported as:
Mean · score on a scale
Clinical Benefit
score on a scaleTazemetostat
Clinical Benefit3.4 ± 2.7
SecondaryClinical Benefit Rate

Assess the clinical benefit rate, defined as the proportion of subjects with complete or partial response or stable disease (by RECIST 1.1 criteria) lasting at least 4 months. Per RECiST 1.1 criteria, a complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Stable disease is defined as having neither sufficient shrinkage for a partial response nor sufficient increase for progressive disease, taking as reference the smallest sum diameters while on study.

Time frame:
143 days
Reported as:
Number · percentage of participants
Clinical Benefit Rate
percentage of participantsTazemetostat
Clinical Benefit Rate0

Adverse events

Collected over Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tazemetostat9/10 (90%)4/10 (40%)10/10 (100%)
Most frequent serious events
Most frequent serious events
EventTazemetostat
Pleural effusionRespiratory, thoracic and mediastinal disorders3/10
Superior vena cava syndromeVascular disorders1/10
Atrial fibrillationCardiac disorders1/10
OsteomyelitisMusculoskeletal and connective tissue disorders1/10
Lung infectionInfections and infestations1/10
Disease ProgressionGeneral disorders1/10
Progressive DiseaseGeneral disorders1/10
Most frequent other events
Showing 10 of 45
Most frequent other events
EventTazemetostat
NauseaGastrointestinal disorders7/10
FatigueGeneral disorders6/10
VomitingGastrointestinal disorders5/10
AnemiaBlood and lymphatic system disorders2/10
ConstipationGastrointestinal disorders2/10
CoughRespiratory, thoracic and mediastinal disorders2/10
DyspneaRespiratory, thoracic and mediastinal disorders2/10
Gastroesophageal reflux diseaseGastrointestinal disorders2/10
HypokalemiaMetabolism and nutrition disorders2/10
Muscle crampMusculoskeletal and connective tissue disorders2/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Tazemetostat
<=18 years0
Between 18 and 65 years10
>=65 years0
Age, Continuous
Age, Continuous(years)Tazemetostat
Mean40 (20 to 64)
Sex: Female, Male
Sex: Female, Male(Participants)Tazemetostat
Female6
Male4
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Tazemetostat
Hispanic or Latino1
Not Hispanic or Latino9
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Tazemetostat
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White8
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Tazemetostat
United States10
08

Study locations

1 site
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04917042
Collaborators
Epizyme, Inc.
Responsible party
Sponsor
First posted
Jun 8, 2021
Start date
Aug 25, 2021
Primary completion
Feb 14, 2025
Completion
Dec 2026 (estimated)
Results posted
Feb 4, 2026
Last update
Jun 4, 2026

Study contacts

Joanne Lagmay, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Tazemetostat

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