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EZH2 Inhibitor

Tazemetostat for Solid Cancers and Lymphoma

Phase 2
Waitlist Available
Led By Susan N Chi
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) >= 1000/mm^3, Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment), Hemoglobin >= 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions)
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as specified
Must not have
On complete blood count (CBC) differential, patients must not have any significant morphologic abnormalities concerning for myeloproliferative neoplasm (MPN)/myelodysplastic syndrome (MDS) or T- acute lymphoblastic leukemia (ALL)
Patients who have an uncontrolled infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial studies how well tazemetostat works in children with certain difficult-to-treat cancers that have specific gene mutations. Tazemetostat is a pill that aims to stop cancer cell growth by blocking a specific protein. The goal is to see if this treatment can help these children when other treatments have failed. Tazemetostat is already approved for treating various cancers, including certain brain tumors in children.

Who is the study for?
This trial is for patients with relapsed or refractory advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with specific gene mutations (EZH2, SMARCB1, SMARCA4). Participants must have measurable disease and recovered from previous cancer therapies. They need adequate blood counts and organ function and can't have had prior EZH2 inhibitor treatment.
What is being tested?
The trial tests Tazemetostat's effectiveness in stopping tumor growth by blocking a protein called EZH2. It targets patients whose cancers haven't responded to other treatments and who carry certain genetic mutations that may be affected by this drug.
What are the potential side effects?
Potential side effects of Tazemetostat include fatigue, nausea, vomiting, constipation, decreased appetite and weight loss. There might also be changes in liver enzymes or blood cell counts leading to an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood counts meet the required levels and I haven't needed platelet transfusions in the last week.
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My kidney function is normal or near normal.
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I am enrolled in APEC1621SC and assigned to MATCH in APEC1621C due to an actionable mutation.
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I have never taken tazemetostat or similar medications.
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Your bilirubin, SGPT (ALT), serum albumin, corrected QT (QTc) interval, and international normalized ratio (INR) need to be within certain levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood tests do not show signs of specific blood disorders.
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I do not have any infections that are currently uncontrolled.
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I am not taking medication that strongly affects liver enzyme CYP3A4.
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I have a history of T-lymphoblastic lymphoma or leukemia.
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I do not have severe low blood counts or a history of bone marrow cancer.
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I have never had myeloid malignancies or myelodysplastic syndrome.
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I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Percentage of Patients Experiencing Grade 3 or 4 Adverse Events
Progression-free Survival (PFS)
Other study objectives
Biomarker Predictors of Response to Tazemetostat
Change in Tumor Genomics

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%
Blood creatinine increased
18%
Weight decreased
18%
Thrombocytopenia
18%
Neutropenia
18%
Nausea
12%
Herpes simplex
12%
Amylase increased
12%
Malaise
12%
Pneumonia
12%
Urinary tract infection
12%
Influenza
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Osteonecrosis of jaw
6%
Hypoalbuminaemia
6%
Blood pressure decreased
6%
Rash maculo-papular
6%
Blood zinc decreased
6%
Phlebitis
6%
Nail disorder
6%
Gamma-glutamyltransferase increased
6%
Musculoskeletal chest pain
6%
Gastric cancer
6%
Traumatic intracranial haemorrhage
6%
Pyrexia
6%
Electrocardiogram QT prolonged
6%
Aspartate aminotransferase increased
6%
Non-small cell lung cancer
6%
Fatigue
6%
Oedema peripheral
6%
Impetigo
6%
Haematochezia
6%
Tooth disorder
6%
Bronchitis
6%
Gastroenteritis
6%
Abdominal pain
6%
Large intestine polyp
6%
Pneumocystis jirovecii pneumonia
6%
Hypogammaglobulinaemia
6%
Traumatic fracture
6%
Alanine aminotransferase increased
6%
Myalgia
6%
Visual field defect
6%
Insomnia
6%
Haematuria
6%
Hypertonic bladder
6%
Upper respiratory tract inflammation
6%
Skin exfoliation
6%
Immature granulocyte count 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: Treatment (tazemetostat)Experimental Treatment1 Intervention
Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~1050

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Hodgkin's Lymphoma treatments often target specific molecular pathways to inhibit tumor growth and survival. For example, Tazemetostat, an EZH2 inhibitor, works by blocking the EZH2 enzyme, which is involved in the methylation of histones and regulation of gene expression. This inhibition can prevent the proliferation of cancer cells and induce apoptosis. Targeted therapies like this are crucial for Hodgkin's Lymphoma patients as they offer a more precise treatment approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
[New therapeutic strategies in non-Hodgkin lymphomas and Hodgkin lymphoma].

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,010,817 Total Patients Enrolled
Children's Oncology GroupNETWORK
457 Previous Clinical Trials
239,810 Total Patients Enrolled
Susan N ChiPrincipal InvestigatorChildren's Oncology Group

Media Library

Tazemetostat (EZH2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03213665 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Treatment (tazemetostat)
Hodgkin's Lymphoma Clinical Trial 2023: Tazemetostat Highlights & Side Effects. Trial Name: NCT03213665 — Phase 2
Tazemetostat (EZH2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03213665 — Phase 2
~3 spots leftby Oct 2025