Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02875548
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Epizyme, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This rollover study will provide continuing availability to tazemetostat as a single agent to subjects who have completed their participation in an antecedent tazemetostat study (either with monotherapy or combination therapy).

Condition or disease Intervention/treatment Phase
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) Drug: Tazemetostat Phase 1 Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study
Actual Study Start Date : August 30, 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Open-label Tazemetostat
Subjects will continue to receive the same tazemetostat dose and schedule as specified in their antecedent tazemetostat protocol. For subjects 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 the histone-lysine methyltransferase EZH2 gene.
Other Names:
  • EPZ-6438
  • E7438


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The long-term safety profile of tazemetostat measured by number of AEs and duration of exposure to tazemetostat [ Time Frame: From the date of first dose to discontinuation for any reason, including disease progression, withdrawal of consent or death, up to 7 years ]

Secondary Outcome Measures :
  1. The overall survival (OS) of subjects receiving tazemetostat [ Time Frame: From the date of the first dose of tazemetostat to the date of death due to any cause, up to 7 years ]
    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


Other Outcome Measures:
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875548


Locations
Show Show 24 study locations
Sponsors and Collaborators
Epizyme, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Epizyme, Inc.
ClinicalTrials.gov Identifier: NCT02875548    
Other Study ID Numbers: EZH-501
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Epizyme, Inc.:
Epizyme
Tazverik
Tazemetostat (EPZ-6438)
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Sarcoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Mesothelioma
Sarcoma, Synovial
Carcinoma, Medullary
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Connective and Soft Tissue
 Lymphoma, B-Cell
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms, Mesothelial
Neoplasms, Connective Tissue
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Carcinoma
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Nerve Tissue