RecruitingPhase 1NCT04241835

A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function

A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects With Moderate and Severe Hepatic Impairment With Advanced Malignancies


Sponsor

Epizyme, Inc.

Enrollment

24 participants

Start Date

Jan 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the study drug tazemetostat. The pharmacokinetics of the study drug in participants with advanced solid tumors and moderate or severe hepatic (liver) impairment will be compared with participants with advanced malignancies and normal hepatic function. An advanced malignancy is a cancer that has recurred (come back) after prior treatment or hasn't controlled with treatment. The trial will also study the safety of the study drug in participants (how well it is tolerated).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing blood levels, safety, and effects of tazemetostat — an oral cancer drug that targets a specific protein involved in cancer cell growth — given at different doses or formulations to patients with advanced solid tumors or blood cancers that have stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced solid tumor that has progressed after standard treatments, with no remaining standard therapy options, OR a blood cancer that has relapsed after at least 2 standard treatments - You have measurable or evaluable disease on imaging - You are in reasonably good overall health (ECOG performance status 0-2) - Your expected survival is more than 3 months - Your prior treatment toxicities have largely resolved - You can swallow and retain oral medications **You may NOT be eligible if...** - You have had chemotherapy, targeted therapy, or major surgery within 28 days before study entry - You have significant organ dysfunction (blood counts, kidneys, liver) - You are pregnant or breastfeeding - You have serious uncontrolled gastrointestinal conditions that prevent absorbing oral medications - Your cancer has not failed at least the required number of prior treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTazemetostat

Tazemetostat (EPZ-6438) in tablet form at a dose of 800 mg once daily on days 1 and 15 and twice daily on days 5 to 14 of the first 28-day cycle. Participants may continue tazemetostat treatment at 800 mg twice daily in additional 28-day cycles until progression or unacceptable toxicity.


Locations(18)

Florida Cancer Specialists & Research Institute

Lake Mary, Florida, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

Hematology Oncology Consultants

Royal Oak, Michigan, United States

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, United States

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Gabrail Cancer Center

Canton, Ohio, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Oncology Consultants - Texas Medical Center

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Antwerp University Hospital

Edegem, Antwerp, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Institut Bergonie

Bordeaux, France

Centre Oscar Lambret

Lille, France

Hopital de la Timone

Marseille, France

Institut de Cancérologie Strasbourg Europe

Strasbourg, France

MedPolonia

Poznan, Greater Poland Voivodeship, Poland

Biokinetica S.A Przychodnia Jozefow

Józefów, Masovian Voivodeship, Poland

Summit Clinical Research, s.r.o

Bratislava, Slovakia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04241835


Related Trials