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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02875548
Registration number
NCT02875548
Ethics application status
Date submitted
5/08/2016
Date registered
23/08/2016
Date last updated
3/06/2024
Titles & IDs
Public title
A Study to Assess the Long-term Safety of Tazemetostat
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Scientific title
Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study
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Secondary ID [1]
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2015-004984-35
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Secondary ID [2]
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EZH-501
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Universal Trial Number (UTN)
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Trial acronym
TRuST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma (DLBCL)
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Follicular Lymphoma (FL)
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Synovial Sarcoma
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Epitheliod Sarcoma (ES)
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Mesothelioma
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Advanced Solid Tumors
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Renal Medullary Carcinoma
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Non-Hodgkin Lymphoma (NHL)
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Cancer
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Lung - Mesothelioma
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Cancer
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Neuroendocrine tumour (NET)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tazemetostat
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.
Treatment: Drugs: Tazemetostat
Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of enhancer of Zeste homolog 2 (EZH2), a histone-lysine N-methyltransferase enzyme.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Until end of study an average of 7 years
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Primary outcome [2]
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Duration of Study Drug Exposure
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Assessment method [2]
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The average study drug exposure duration will be reported.
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Timepoint [2]
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Until end of study an average of 7 years
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Secondary outcome [1]
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The overall survival (OS)
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Assessment method [1]
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Defined as the interval of time between the date of the first dose of tazemetostat and the date of death due to any cause
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Timepoint [1]
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Until end of study an average of 7 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/08/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
3/11/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Medical Centre- Monash Campus - Clayton
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Recruitment hospital [2]
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Geelong Hospital - Geelong
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Recruitment hospital [3]
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Peter MacCallum Cancer Institute - Melbourne
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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- Geelong
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Recruitment postcode(s) [3]
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3002 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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Florida
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United States of America
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Michigan
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United States of America
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New York
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Belgium
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Leuven
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France
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Bordeaux Cedex
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France
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Caen
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France
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Lille Cedex
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France
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Paris
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France
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Pierre-Bénite
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France
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Rennes Cedex
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France
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Rouen
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France
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Villejuif
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Poland
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Kraków
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Poland
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Warszawa
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Ukraine
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Kharkiv
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United Kingdom
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Glasgow
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United Kingdom
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Leicester
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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State/province [21]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Epizyme, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02875548
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ipsen Medical Director
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Address
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Ipsen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02875548
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