A Study to Assess Long-term Safety of Tazemetostat in Adult Participants of All Ages With Any Disease Treated With Tazemetostat in a Previous Clinical Study
TRuST
Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study
3 other identifiers
interventional
58
7 countries
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2016
Longer than P75 for phase_1
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedStudy Start
First participant enrolled
August 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2025
CompletedNovember 4, 2025
October 1, 2025
9.1 years
August 5, 2016
October 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs)
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
The average study drug exposure duration will be reported.
Until end of study an average of 7 years
Secondary Outcomes (1)
The overall survival (OS)
Until end of study an average of 7 years
Study Arms (1)
Open-label Tazemetostat
EXPERIMENTALParticipants 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.
Interventions
Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of enhancer of Zeste homolog 2 (EZH2), a histone-lysine N-methyltransferase enzyme.
Eligibility Criteria
You may qualify if:
- Subjects must meet ALL criteria to be eligible for enrollment in this study.
- Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
- 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.
- Has voluntarily provided signed written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
- Has a life expectancy of ≥3 months.
- 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
You may not qualify if:
- Subjects meeting ANY of the following criteria must NOT be enrolled in this study:
- 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.
- 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.
- Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE v5 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
- Has a prior history of T-LBL/T-ALL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epizyme, Inc.lead
Study Sites (34)
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
California Cancer Associates For Research And Excellence, cCARE
Santa Fe, California, 92024, United States
Hematology Oncology Associates of the Treasure Coast - Port St. Lucie
Port Saint Lucie, Florida, 34952, United States
Moffitt
Tampa, Florida, 33612, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Central Care Cancer Center
Bolivar, Missouri, 65613, United States
Astera Cancer Center
East Brunswick, New Jersey, 08816, United States
Columbia University Medical Center
New York, New York, 10019, United States
David H. Koch Center for Cancer Care at memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Princess Alexandra Hospital
Alexandra, Australia
Monash Medical Centre- Monash Campus
Clayton, 3168, Australia
Geelong Hospital
Geelong, Australia
Peter MacCallum Cancer Institute
Melbourne, 3002, Australia
Monash Health
Monash, Australia
University Hospital (UZ) Leuven
Leuven, 3000, Belgium
Institut Bergonie
Bordeaux, 33076, France
CHU de Caen - Hôpital Côte de Nacre
Caen, 14033, France
CHRU de Lile- Hopital Claude Huriez
Lille, 59037, France
CHU de Montpellier - Hopital Saint Eloi
Montpellier, France
Hôpital Saint Louis - AP-HP
Paris, 75010, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
CHU Rennes- Hopital Pontchaillou
Rennes, 35033, France
Centre Henri Becquerel
Rouen, 76038, France
Gustave Roussay
Villejuif, 94805, France
Pratia MCM Krakow
Krakow, 30-510, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej
Warsaw, Poland
S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"
Kharkiv, 61024, Ukraine
Beatson, West of Scotland Cancer Centre
Glasgow, United Kingdom
Oncology and Haematology Clinical Trials Unit
Leicester, LEI 5WW, United Kingdom
Clatterbridge Cancer Centre
Liverpool, L7 8XP, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2016
First Posted
August 23, 2016
Study Start
August 30, 2016
Primary Completion
September 26, 2025
Study Completion
September 26, 2025
Last Updated
November 4, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.