24 Participants Needed

Tazemetostat for Advanced Cancer with Liver Impairment

Recruiting at 8 trial locations
SA
CT
CT
IR
Overseen ByIpsen Recruitment Enquiries
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any chemotherapy, targeted therapy, or major surgery treatments at least 28 days before joining. If you're on daily or weekly chemotherapy without delayed toxicity, a 14-day break might be okay. Also, you can't take medications that are known potent CYP3A4 inducers or inhibitors.

What data supports the effectiveness of the drug Tazemetostat for advanced cancer with liver impairment?

Tazemetostat has shown effectiveness in treating epithelioid sarcoma, with 15% of patients responding to the drug and 67% of those responses lasting at least 6 months. It is also being studied for other cancers like B-cell lymphoma, indicating its potential in treating various tumor types.12345

Is tazemetostat generally safe for humans?

Tazemetostat has been studied in various clinical trials, including for B-cell non-Hodgkin lymphoma, and has shown a manageable safety profile. Common side effects include lymphopenia (low white blood cell count), and some serious side effects like hypertriglyceridemia (high levels of triglycerides in the blood) and pneumonia aspiration were reported but were not related to the drug. Overall, the safety profile is considered acceptable.12346

What makes the drug Tazemetostat unique for treating advanced cancer with liver impairment?

Tazemetostat is unique because it targets a specific enzyme called EZH2, which is involved in cancer cell growth, making it different from traditional chemotherapy drugs that target rapidly dividing cells in general. This targeted approach may offer a novel treatment option for patients with advanced cancer and liver impairment, where standard treatments may not be effective or safe.7891011

What is the purpose of this trial?

This trial tests tazemetostat, an oral medication, in patients with advanced solid tumors and different liver functions. It aims to understand how the drug behaves in the body and its safety. Researchers will measure drug levels in the blood and monitor for side effects. Tazemetostat is approved by the FDA for certain types of cancer.

Research Team

IM

Ipsen Medical Director

Principal Investigator

Ipsen

Eligibility Criteria

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.

Inclusion Criteria

Must have evaluable or measurable disease
I can take pills and don't have major stomach or bowel issues affecting drug absorption.
I understand the study details and have signed the consent form.
See 13 more

Exclusion Criteria

I am not taking strong CYP3A4 drugs or St. John's Wort.
Known hypersensitivity to any of the components of tazemetostat
I have severe blood cell count issues or a history of blood cancer.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1 Treatment

Participants receive a single oral 800 mg dose of tazemetostat on Day 1 and Day 15, and twice daily from Day 5 to Day 14. Blood samples for PK analysis are obtained.

18 days
Multiple visits for PK sampling

Part 2 Treatment

Participants continuing treatment receive tazemetostat (oral 800 mg dose) tablets twice daily in repeated 28-day cycles until clinical progression or unacceptable toxicity.

28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment. An end of study visit for safety assessment occurs 30 days after the last dose.

30 days

Treatment Details

Interventions

  • Tazemetostat
Trial Overview 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.
Participant Groups
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.

Tazemetostat is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tazverik for:
  • Epithelioid sarcoma
  • Follicular lymphoma
🇪🇺
Approved in European Union as Tazverik for:
  • Epithelioid sarcoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Epizyme, Inc.

Lead Sponsor

Trials
34
Recruited
2,800+

Sponsor GmbH

Collaborator

Trials
36
Recruited
11,000+

Findings from Research

Tazemetostat (Tazverik™) is the first approved treatment specifically for adults and adolescents aged 16 years and older with locally advanced or metastatic epithelioid sarcoma, receiving accelerated approval in January 2020 in the USA.
The recommended dosage is 800 mg taken orally twice daily, and Tazemetostat is also being studied for other cancers, including diffuse large B-cell lymphoma and follicular lymphoma, indicating its potential broader therapeutic applications.
Tazemetostat: First Approval.Hoy, SM.[2021]
In a phase I study involving seven Japanese patients with relapsed or refractory B-cell non-Hodgkin lymphoma, tazemetostat demonstrated a promising objective response rate of 57%, indicating its potential effectiveness in treating this type of cancer.
The treatment was well-tolerated, with no dose-limiting toxicities observed and only mild adverse events such as thrombocytopenia and dysgeusia reported, suggesting a favorable safety profile for tazemetostat.
Phase 1 study of tazemetostat in Japanese patients with relapsed or refractory B-cell lymphoma.Munakata, W., Shirasugi, Y., Tobinai, K., et al.[2021]
Tazemetostat is the first FDA-approved epigenetic therapy for solid tumors, specifically targeting the EZH2 enzyme involved in gene silencing.
This therapy is particularly effective for tumors with mutations in the SWI/SNF chromatin remodeling complex, such as most epithelioid sarcomas, highlighting its potential in treating these specific cancer types.
Epigenetic Therapy for Epithelioid Sarcoma.Rothbart, SB., Baylin, SB.[2021]

References

Tazemetostat: First Approval. [2021]
Phase 1 study of tazemetostat in Japanese patients with relapsed or refractory B-cell lymphoma. [2021]
Epigenetic Therapy for Epithelioid Sarcoma. [2021]
Initial testing (stage 1) of tazemetostat (EPZ-6438), a novel EZH2 inhibitor, by the Pediatric Preclinical Testing Program. [2022]
First EZH2 Inhibitor Approved-for Rare Sarcoma. [2020]
Phase II study of tazemetostat for relapsed or refractory B-cell non-Hodgkin lymphoma with EZH2 mutation in Japan. [2021]
Synthesis and antifolate properties of 9-alkyl-10-deazaminopterins. [2019]
Future directions in the development of pemetrexed. [2019]
The current state of pemetrexed in ovarian cancer. [2015]
Pemetrexed disodium in ovarian cancer treatment. [2015]
11.United Statespubmed.ncbi.nlm.nih.gov
New folate analogs of the 10-deaza-aminopterin series: markedly increased antitumor activity of the 10-ethyl analog compared to the parent compound and methotrexate against some human tumor xenografts in nude mice. [2015]
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