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EZH2 Inhibitor

Tazemetostat for Solid Cancers

Phase 2

Recruiting

Led By Ki Chung, MD

Research Sponsored by Prisma Health-Upstate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Progression of disease following approved therapies or for which no standard therapy exists

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, estimated to be 1 year after the last subject enrolled

Awards & highlights

Study Summary

This trial is testing whether or not a drug that targets EZH2 will be effective in treating patients with B-cell non-Hodgkin's lymphoma, epithelioid sarcoma, and other solid tumors.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors that have an ARID1A mutation, excluding those with epithelioid sarcoma. Participants must have tried other treatments without success and should not be pregnant, breastfeeding, or have had major surgery recently. They need to be able to take oral medication and not have a history of certain cancers or severe heart conditions.Check my eligibility

What is being tested?

The study tests Tazemetostat, an FDA-approved drug thought to benefit patients with specific tumor mutations by inhibiting a protein called EZH2. The goal is to see if this drug can provide significant clinical benefits in malignancies associated with the ARID1A mutation.See study design

What are the potential side effects?

While the specific side effects for this trial are not listed here, Tazemetostat may commonly cause fatigue, nausea, constipation, coughing and shortness of breath among others. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My condition worsened after treatment or no standard treatment is available for me.

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My kidney function is good, with creatinine below 2.0 or clearance above 35 mL/min.

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My blood tests show my bone marrow is working well.

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My cancer, which is not epithelioid sarcoma, has an ARID1A mutation.

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My liver is functioning well according to recent tests.

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I am over 18 and can give my consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, estimated to be 1 year after the last subject enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, estimated to be 1 year after the last subject enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, estimated to be 1 year after the last subject enrolled for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate

Secondary outcome measures

Disease Control Rate

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

Fatigue

Oedema peripheral

Blood pressure decreased

Traumatic intracranial haemorrhage

Gastric cancer

Non-small cell lung cancer

Aspartate aminotransferase increased

Myalgia

Gastroenteritis

Immature granulocyte count increased

Nail disorder

Blood zinc decreased

Gamma-glutamyltransferase increased

Skin exfoliation

Haematochezia

Pyrexia

Hypogammaglobulinaemia

Electrocardiogram QT prolonged

Hypoalbuminaemia

Abdominal pain

Bronchitis

Pneumocystis jirovecii pneumonia

Large intestine polyp

Haematuria

Visual field defect

Insomnia

Phlebitis

Tooth disorder

Osteonecrosis of jaw

Impetigo

Traumatic fracture

Hypertonic bladder

Upper respiratory tract inflammation

Musculoskeletal chest pain

Rash maculo-papular

Alanine aminotransferase increased

Cataract

Mechanical ileus

Atypical pneumonia

Periodontitis

Pneumonia aspiration

Leukopenia

Pericardial effusion

Conjunctival haemorrhage

Visual impairment

Epigastric discomfort

Oral herpes

Paronychia

Fall

Postoperative delirium

Procedural pain

Skin laceration

Tooth fracture

Hyperglycaemia

Hyperkalaemia

Hyperuricaemia

Pain in extremity

Tendon disorder

Myelodysplastic syndrome

Muscle spasticity

Peripheral motor neuropathy

Sciatica

Syncope

Asthma

Dysphonia

Erythema multiforme

Keloid scar

100%

80%

60%

40%

20%

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

tazemetostat 800 mg po twice daily in continuous 28- day cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tazemetostat

2016

Completed Phase 2

~780

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Prisma Health-UpstateLead Sponsor

82 Previous Clinical Trials

42,898 Total Patients Enrolled

IpsenIndustry Sponsor

345 Previous Clinical Trials

73,188 Total Patients Enrolled

Epizyme, Inc.Industry Sponsor

33 Previous Clinical Trials

2,886 Total Patients Enrolled

Media Library

ARID1A Mutation Research Study Groups: Tazemetostat

Frequently Asked Questions

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

Have there been any prior investigations regarding Tazemetostat?

"Presently, 20 different trials researching Tazemetostat are ongoing. Two of those studies have reached Phase 3 and the majority of them are based in Marshfield, Wisconsin. Nevertheless, 1,302 medical centres across the globe are running clinical trials examining this treatment."

Answered by AI

Is this research initiative still open to enrollees?

"Affirmative. The clinical trial portal, clinicaltrials.gov, posts that this experiment is actively enrolling participants since the first post of January 6th 2022 and was last updated on February 15th 2022. Currently recruiting 40 patients from a single location."

Answered by AI

Is Tazemetostat a reliable treatment option for individuals?

"Upon investigation, our team at Power rated Tazemetostat's safety as a 2 due to the lack of clinical data in support of its efficacy. This is expected for Phase 2 trials."

Answered by AI

Does this research endeavor represent a pioneering effort?

"At present, 20 clinical trials are ongoing for Tazemetostat in 533 cities spread across 21 countries. The first drug study was initiated by Epizyme Inc. back in 2015 and comprised of 250 participants; since then the company has conducted 8 further investigations with Phase 2 approval status achieved."

Answered by AI

How many participants can this clinical trial accommodate?

"Affirmative. According to information featured on clinicaltrials.gov, this clinical trial is presently recruiting patients and was initially put up for public view on the 6th of January 2022 before being updated a month later in February 15th 2021. 40 individuals are required to come forward from 1 single site."

Answered by AI

Recent research and studies

Nature GeneticsJournal

ARID1A Determines Luminal Identity and Therapeutic Response in Estrogen-receptor-positive Breast Cancer

Xu, Guotai, Sagar Chhangawala, Emiliano Cocco, Pedram Razavi, Yanyan Cai, Jordan E Otto, Lorenzo Ferrando, et al.. 2020. “ARID1A Determines Luminal Identity and Therapeutic Response in Estrogen-receptor-positive Breast Cancer”. Nature Genetics. Springer Science and Business Media LLC. doi:10.1038/s41588-019-0554-0.

Nature MedicineJournal

Synthetic Lethality by Targeting EZH2 Methyltransferase Activity in Arid1a-mutated Cancers

Bitler, Benjamin G, Katherine M Aird, Azat Garipov, Hua Li, Michael Amatangelo, Andrew V Kossenkov, David C Schultz, et al.. 2015. “Synthetic Lethality by Targeting EZH2 Methyltransferase Activity in Arid1a-mutated Cancers”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/nm.3799.

Gastric CancerJournal

Selective Sensitivity of EZH2 Inhibitors Based on Synthetic Lethality in Arid1a-deficient Gastric Cancer

Yamada, Leo, Motonobu Saito, Aung Kyi Thar Min, Katsuharu Saito, Mai Ashizawa, Koji Kase, Shotaro Nakajima, et al.. 2020. “Selective Sensitivity of EZH2 Inhibitors Based on Synthetic Lethality in Arid1a-deficient Gastric Cancer”. Gastric Cancer. Springer Science and Business Media LLC. doi:10.1007/s10120-020-01094-0.

Clinical EpigeneticsJournal