Back to resultsA Study to Assess the Long-term Safety of Tazemetostat (TRuST)
Primary Purpose
Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Synovial Sarcoma
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tazemetostat
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma (DLBCL) focused on measuring Epizyme, Tazverik, Tazemetostat (EPZ-6438)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
Sites / Locations
- University of Arizona Cancer Center
- Moffitt
- University of Michigan
- Columbia University Medical Center
- Monash Medical Centre- Monash Campus
- Geelong Hospital
- Peter MacCallum Cancer Institute
- University Hospital (UZ) Leuven
- Institut Bergonie
- CHU de Caen - Hôpital Côte de Nacre
- CHRU de Lile- Hopital Claude Huriez
- Hôpital Saint Louis - AP-HP
- Centre Hospitalier Lyon Sud
- CHU Rennes- Hopital Pontchaillou
- Centre Henri Becquerel
- Gustave Roussay
- Pratia MCM Krakow
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej
- S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"
- Beatson, West of Scotland Cancer Centre
- Oncology and Haematology Clinical Trials Unit
- Clatterbridge Cancer Centre
- Hammersmith Hospital
- The Christie NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-label Tazemetostat
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Duration of Study Drug Exposure
The average study drug exposure duration will be reported.
Secondary Outcome Measures
The overall survival (OS)
Defined as the interval of time between the date of the first dose of tazemetostat and the date of death due to any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02875548
Brief Title
A Study to Assess the Long-term Safety of Tazemetostat
Acronym
TRuST
Official Title
Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epizyme, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Synovial Sarcoma, Epitheliod Sarcoma (ES), Mesothelioma, Advanced Solid Tumors, Renal Medullary Carcinoma, Non-Hodgkin Lymphoma (NHL)
Keywords
Epizyme, Tazverik, Tazemetostat (EPZ-6438)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open-label Tazemetostat
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tazemetostat
Other Intervention Name(s)
EPZ-6438, E7438, IPN60200
Intervention Description
Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of enhancer of Zeste homolog 2 (EZH2), a histone-lysine N-methyltransferase enzyme.
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs)
Description
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.
Time Frame
Until end of study an average of 7 years
Title
Duration of Study Drug Exposure
Description
The average study drug exposure duration will be reported.
Time Frame
Until end of study an average of 7 years
Secondary Outcome Measure Information:
Title
The overall survival (OS)
Description
Defined as the interval of time between the date of the first dose of tazemetostat and the date of death due to any cause
Time Frame
Until end of study an average of 7 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Moffitt
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Monash Medical Centre- Monash Campus
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
Geelong Hospital
City
Geelong
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
University Hospital (UZ) Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Institut Bergonie
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de Caen - Hôpital Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHRU de Lile- Hopital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Saint Louis - AP-HP
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
CHU Rennes- Hopital Pontchaillou
City
Rennes Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Gustave Roussay
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Pratia MCM Krakow
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej
City
Warszawa
Country
Poland
Facility Name
S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Beatson, West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
Oncology and Haematology Clinical Trials Unit
City
Leicester
ZIP/Postal Code
LEI 5WW
Country
United Kingdom
Facility Name
Clatterbridge Cancer Centre
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
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A Study to Assess the Long-term Safety of Tazemetostat
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