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Epigenetic modifier

Tazemetostat for Nerve Sheath Cancer

Phase 2
Recruiting
Led By Joanne Lagmay, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients ≥ 12 years of age at the time of enrollment
No prior exposure to Tazemetostat or other inhibitor(s) of EZH2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will investigate whether tazemetostat can shrink tumors in people with a rare cancer that has come back or spread.

Who is the study for?
This trial is for individuals aged 12 and older with a specific type of cancer called malignant peripheral nerve sheath tumors that have come back or spread. Participants need to have recovered from previous cancer treatments, be able to take oral medication, not be pregnant or breastfeeding, and must use contraception. They should only have this one active cancer and be in stable condition.Check my eligibility
What is being tested?
The study is testing Tazemetostat's effectiveness on patients with recurrent or metastatic malignant peripheral nerve sheath tumors. It's an open-label phase 2 trial, meaning everyone gets the drug and both the patient and doctor know what’s being given.See study design
What are the potential side effects?
Tazemetostat may cause side effects such as fatigue, nausea, loss of appetite, changes in blood counts (like anemia), risk of infections due to low white blood cell count, muscle pain, coughing, shortness of breath among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 12 years old or older.
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I have never taken Tazemetostat or similar medications.
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My cancer has returned or spread and can be measured by standard tests.
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I am active and can do most of my daily activities despite my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate
Secondary outcome measures
Clinical benefit
Clinical benefit rate
Progression free survival
+1 more

Side effects data

From 2021 Phase 2 trial • 20 Patients • NCT03456726
53%
Dysgeusia
41%
Nasopharyngitis
29%
Upper respiratory tract infection
29%
Blood creatine phosphokinase increased
29%
Lymphopenia
29%
Constipation
29%
Stomatitis
24%
Rash
18%
Thrombocytopenia
18%
Weight decreased
18%
Blood creatinine increased
18%
Neutropenia
18%
Nausea
12%
Urinary tract infection
12%
Influenza
12%
Pneumonia
12%
Amylase increased
12%
Herpes simplex
12%
Malaise
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Fatigue
6%
Oedema peripheral
6%
Blood pressure decreased
6%
Traumatic intracranial haemorrhage
6%
Gastric cancer
6%
Non-small cell lung cancer
6%
Aspartate aminotransferase increased
6%
Myalgia
6%
Gastroenteritis
6%
Immature granulocyte count increased
6%
Nail disorder
6%
Blood zinc decreased
6%
Gamma-glutamyltransferase increased
6%
Skin exfoliation
6%
Haematochezia
6%
Pyrexia
6%
Hypogammaglobulinaemia
6%
Electrocardiogram QT prolonged
6%
Hypoalbuminaemia
6%
Abdominal pain
6%
Bronchitis
6%
Pneumocystis jirovecii pneumonia
6%
Large intestine polyp
6%
Haematuria
6%
Visual field defect
6%
Insomnia
6%
Phlebitis
6%
Tooth disorder
6%
Osteonecrosis of jaw
6%
Impetigo
6%
Traumatic fracture
6%
Hypertonic bladder
6%
Upper respiratory tract inflammation
6%
Musculoskeletal chest pain
6%
Rash maculo-papular
6%
Alanine aminotransferase increased
6%
Cataract
6%
Mechanical ileus
6%
Atypical pneumonia
6%
Periodontitis
6%
Pneumonia aspiration
6%
Leukopenia
6%
Pericardial effusion
6%
Conjunctival haemorrhage
6%
Visual impairment
6%
Epigastric discomfort
6%
Oral herpes
6%
Paronychia
6%
Fall
6%
Postoperative delirium
6%
Procedural pain
6%
Skin laceration
6%
Tooth fracture
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Hyperuricaemia
6%
Pain in extremity
6%
Tendon disorder
6%
Myelodysplastic syndrome
6%
Muscle spasticity
6%
Peripheral motor neuropathy
6%
Sciatica
6%
Syncope
6%
Asthma
6%
Dysphonia
6%
Erythema multiforme
6%
Keloid scar
100%
80%
60%
40%
20%
0%
Study treatment Arm
Participants With Follicular Lymphoma
Participants With Diffuse Large B-cell Lymphoma

Trial Design

1Treatment groups
Experimental Treatment
Group I: tazemetostatExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,643 Total Patients Enrolled
Epizyme, Inc.Industry Sponsor
33 Previous Clinical Trials
2,902 Total Patients Enrolled
Joanne Lagmay, MDPrincipal InvestigatorUniversity of Florida

Media Library

Tazemetostat (Epigenetic modifier) Clinical Trial Eligibility Overview. Trial Name: NCT04917042 — Phase 2
Peripheral Nerve Sheath Tumor Research Study Groups: tazemetostat
Peripheral Nerve Sheath Tumor Clinical Trial 2023: Tazemetostat Highlights & Side Effects. Trial Name: NCT04917042 — Phase 2
Tazemetostat (Epigenetic modifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04917042 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any medical conditions which would make a person ineligible for this research?

"The enrolment requirements for this study are that patients must have neurofibrosarcoma and be within the age range of 12 to 99 years old. The clinical trial intends to enroll around 24 individuals in total."

Answered by AI

Can new patients still sign up for this experiment?

"The clinical trial is still recruiting patients, according to the most recent information available on clinicaltrials.gov. This study was first posted on 8/24/2021 and updated as recently as 8/9/2022."

Answered by AI

Tazemetostat has shown significant efficacy in clinical trials, but are there any long-term risks associated with its use?

"Tazemetostat's safety is based on Phase 2 trial data, which only provides limited support for its use."

Answered by AI

How many subjects are included in this research?

"That is correct, the clinicaltrials.gov website does mention that this trial is open for enrollment. The posting date was 8/24/2021, and the study requires 24 patients from 1 location."

Answered by AI

Is this the first time this kind of clinical trial has been conducted?

"Tazemetostat is being studied in 20 different active clinical trials. These international studies are taking place across 533 cities and 21 countries; with the first one starting back in 2015. The original trial, which was sponsored by Epizyme Inc., completed its Phase 2 drug approval stage after enrolling 250 participants. In the 5 years since that first study, 8 more have been conducted."

Answered by AI

Can young people below the age of 30 participate in this research?

"This clinical trial is open to people aged 12 to 99. There are 14 other studies for those under 18 and 37 for seniors."

Answered by AI

Are there any existing research on Tazemetostat's effects?

"As of right now, there are 20 live studies for the efficacy of Tazemetostat. 2 trials are currently in Phase 3. Many of these clinical trials take place in Indianapolis, Indiana; however, there are a total 1302 locations across the globe conducting similar research."

Answered by AI
~8 spots leftby Sep 2025