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Histone Methyltransferase Inhibitor

Tazemetostat for Advanced Cancer with Liver Impairment

Phase 1
Recruiting
Research Sponsored by Epizyme, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow and retain orally-administered medication and without clinically significant gastrointestinal abnormalities that could alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
Has the ability to understand informed consent and provided signed written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective. It is open to people with certain types of cancer who have normal or impaired liver function.

Who is the study for?
Adults with advanced cancer and liver impairment or normal liver function can join this trial. They should be able to understand the study, have a life expectancy over 3 months, and not have had recent treatments that could affect results. Participants must use effective contraception if of childbearing potential and cannot have certain blood disorders or severe allergies to tazemetostat components.Check my eligibility
What is being tested?
The trial is testing how different levels of liver function affect the blood levels and safety of Tazemetostat in patients with advanced solid tumors. It compares those with moderate/severe liver problems to those with normal liver function, focusing on how well they tolerate the drug.See study design
What are the potential side effects?
Tazemetostat may cause fatigue, digestive issues, changes in blood counts which could lead to bleeding or infection risks, and possibly allergic reactions for those sensitive to its ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills and don't have major stomach or bowel issues affecting drug absorption.
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I understand the study details and have signed the consent form.
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I am a male who will use contraception or practice abstinence during and for 3 months after the study.
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My cancer has advanced after treatment and no standard therapies are available.
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My blood, bone marrow, and kidney functions are all within normal ranges.
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My side effects from previous treatments are mild or stable.
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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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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the pharmacokinetics (PK) of tazemetostat and its metabolite EPZ 6930, AUC0-8: area under the plasma concentration-time curve from time 0 to 8 hours post dose
To evaluate the pharmacokinetics (PK) of tazemetostat and its metabolite EPZ 6930, AUC0-t: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
To evaluate the pharmacokinetics (PK) of tazemetostat and its metabolite EPZ 6930, AUC0-∞: area under the plasma concentration-time curve from time 0 extrapolated to infinity
+4 more
Secondary outcome measures
To evaluate the number of participants with adverse events (AEs) as assessed by CTCAE v5.0

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%
Neutropenia
18%
Blood creatinine increased
18%
Weight decreased
18%
Thrombocytopenia
18%
Nausea
12%
Influenza
12%
Pneumonia
12%
Amylase increased
12%
Herpes simplex
12%
Urinary tract infection
12%
Malaise
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Electrocardiogram QT prolonged
6%
Skin exfoliation
6%
Haematochezia
6%
Aspartate aminotransferase increased
6%
Blood pressure decreased
6%
Rash maculo-papular
6%
Non-small cell lung cancer
6%
Tooth disorder
6%
Immature granulocyte count increased
6%
Large intestine polyp
6%
Pyrexia
6%
Oedema peripheral
6%
Upper respiratory tract inflammation
6%
Hypoalbuminaemia
6%
Blood zinc decreased
6%
Impetigo
6%
Alanine aminotransferase increased
6%
Traumatic intracranial haemorrhage
6%
Abdominal pain
6%
Hypogammaglobulinaemia
6%
Bronchitis
6%
Gastroenteritis
6%
Insomnia
6%
Visual field defect
6%
Gamma-glutamyltransferase increased
6%
Musculoskeletal chest pain
6%
Phlebitis
6%
Haematuria
6%
Hypertonic bladder
6%
Nail disorder
6%
Gastric cancer
6%
Myalgia
6%
Osteonecrosis of jaw
6%
Pneumocystis jirovecii pneumonia
6%
Traumatic fracture
6%
Fatigue
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: Open label TazemetostatExperimental Treatment1 Intervention
Part 1: Participants will receive a single oral 800 mg dose on day 1, and twice daily from day 5 to day 14. Participants will return to the clinical study unit on an out-patient basis from day 15 to day 18. A single oral 800 mg dose of tazemetostat will be administered on day 15. Part 2: Will begin on day 19 and participants continuing treatment in Part 2 will receive tazemetostat (oral 800 mg dose) tablets to be taken twice daily in repeated 28-day cycles.
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?

Epizyme, Inc.Lead Sponsor
33 Previous Clinical Trials
2,830 Total Patients Enrolled
Sponsor GmbHOTHER
30 Previous Clinical Trials
9,822 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
256 Previous Clinical Trials
54,851 Total Patients Enrolled

Media Library

Tazemetostat (Histone Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04241835 — Phase 1
Liver Disease Research Study Groups: Open label Tazemetostat
Liver Disease Clinical Trial 2023: Tazemetostat Highlights & Side Effects. Trial Name: NCT04241835 — Phase 1
Tazemetostat (Histone Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04241835 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Oct 2024