A Study to Assess the Long-term Safety of Tazemetostat (TRuST)

March 27, 2024 updated by: Epizyme, Inc.

Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study

This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy.

The aim of the study will be to assess the long-term safety of tezemetostat.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This open-label, multicenter, global study will provide continuing access to tazemetostat therapy for subjects who have completed their participation in a prior tazemetostat study (either with monotherapy or combination therapy)

without unacceptable toxicity, have not had evidence of tumor progression as defined by disease-appropriate standard criteria, and continue to receive clinical benefit from the therapy.

Subjects will receive tazemetostat as dictated in their antecedent study. Visits will be conducted per Standard of Care (SoC) as appropriate in each country and as determined by the Investigator. Subjects will be followed for long-term safety in addition to time to treatment failure (TTF) and overall survival (OS).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Clayton, Australia, 3168
        • Monash Medical Centre- Monash Campus
      • Geelong, Australia
        • Geelong Hospital
      • Melbourne, Australia, 3002
        • Peter MacCallum Cancer Institute
  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital (UZ) Leuven
  • France
      • Bordeaux Cedex, France, 33076
        • Institut Bergonié
      • Caen, France, 14033
        • CHU de Caen - Hopital Cote de Nacre
      • Lille Cedex, France, 59037
        • CHRU de Lile- Hopital Claude Huriez
      • Paris, France, 75010
        • Hôpital Saint Louis - AP-HP
      • Pierre-Bénite, France, 69310
        • Centre Hospitalier Lyon Sud
      • Rennes Cedex, France, 35033
        • CHU Rennes- Hopital Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Villejuif, France, 94805
        • Gustave Roussay
  • Poland
      • Kraków, Poland, 30-510
        • Pratia MCM Krakow
      • Warszawa, Poland
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej
  • Ukraine
      • Kharkiv, Ukraine, 61024
        • S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"
  • United Kingdom
      • Glasgow, United Kingdom
        • Beatson, West of Scotland Cancer Centre
      • Leicester, United Kingdom, LEI 5WW
        • Oncology and Haematology Clinical Trials Unit
      • Liverpool, United Kingdom, L7 8XP
        • Clatterbridge Cancer Centre
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New York
      • New York, New York, United States, 10019
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects must meet ALL criteria to be eligible for enrollment in this study.
  2. Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
  3. Is currently receiving tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical trial or any other clinical trial being conducted with tazemetostat that is not sponsored by Epizyme (including but not limited to, investigator-initiated trials). For subjects on combination therapy, treatment with other therapeutic(s) must have been completed in the antecedent study or will be provided by a source other than Epizyme if combination therapeutics are continued in this study until disease progression, treatment toxicity, subject preference or death, up to approximately 7 years.
  4. Has voluntarily provided signed written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
  5. Has a life expectancy of ≥3 months.
  6. Has adequate hematologic, (bone marrow [BM] and coagulation factors), renal, and hepatic function. Subject must remain eligible for continued treatment with tazemetostat according to the eligibility and treatment criteria from the antecedent study

Exclusion Criteria:

Subjects meeting ANY of the following criteria must NOT be enrolled in this study:

  1. Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study unless approved by the Medical Monitor.

  2. Has another malignancy other than the one for which they are receiving tazemetostat.

    • Exception: Subject who has been disease-free of a prior malignancy for 5 years or subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible.

  3. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE v5 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
  4. Has a prior history of T-LBL/T-ALL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label Tazemetostat

Participants will continue to receive the same tazemetostat dose and schedule as specified in their antecedent tazemetostat protocol.

For participants on combination therapy, the other therapeutic(s) must have been completed in the antecedent study or be provided by a source other than Epizyme if combination treatment is continued in this clinical rollover study.
Drug: Tazemetostat
Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of enhancer of Zeste homolog 2 (EZH2), a histone-lysine N-methyltransferase enzyme.
Other Names:
  • EPZ-6438
  • E7438
  • IPN60200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs)
Time Frame: Until end of study an average of 7 years
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention Severity of adverse events experienced by all participants will be evaluated by the Investigator based on the CTCAE, version 5.0.
Until end of study an average of 7 years
Duration of Study Drug Exposure
Time Frame: Until end of study an average of 7 years
The average study drug exposure duration will be reported.
Until end of study an average of 7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The overall survival (OS)
Time Frame: Until end of study an average of 7 years
Defined as the interval of time between the date of the first dose of tazemetostat and the date of death due to any cause
Until end of study an average of 7 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to treatment failure (TTF) in subjects receiving tazemetostat
Time Frame: The time from date of first dose of study treatment to treatment discontinuation for any reason including disease progression, treatment toxicity, subject preference or death, up to 7 years
TTF, defined as the time from date of first dose of study drug to treatment discontinuation for any reason, including disease progression, treatment toxicity, subject preference, or death
The time from date of first dose of study treatment to treatment discontinuation for any reason including disease progression, treatment toxicity, subject preference or death, up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epizyme, Inc.

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2016

Primary Completion (Estimated)

November 3, 2025

Study Completion (Estimated)

November 3, 2025

Study Registration Dates

First Submitted

August 5, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimated)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EZH-501
  • 2015-004984-35 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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