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

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ClinicalTrials.gov Identifier: NCT02875548
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Epizyme, Inc.

Brief Summary:
This 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). In addition, long-term safety and overall survival will be collected.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Follicular Lymphoma Malignant Rhabdoid Tumors (MRT) Rhabdoid Tumors of the Kidney (RTK) Atypical Teratoid Rhabdoid Tumors (ATRT) Synovial Sarcoma Epitheliod Sarcoma Mesothelioma Advanced Solid Tumors Drug: Tazemetostat Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tazemetostat Rollover Study (TRuST): An Open-Label Rollover Study
Study Start Date : August 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : April 2024


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




Primary Outcome Measures :
  1. 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) [ Time Frame: From the date of the first dose of tazemetostat to the date of death due to any cause, up to 7 years ]

Other Outcome Measures:
  1. The time to treatment failure (TTF) [ 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 ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Has demonstrated clinical benefit from treatment with tazemetostat.
  2. 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, the other therapeutic(s) must have been completed or will be provided by a source other than Epizyme
  3. Has provided signed written informed consent
  4. Has a life expectancy of >3 months
  5. Has adequate hematopoietic, coagulation, renal and hepatic function. Subject must remain eligible for continued treatment with tazemetostat according to the eligibility and treatment criteria from the antecedent study.
  6. For French subjects only: Is either affiliated with or a beneficiary of a social security category.
  7. Female subjects of childbearing potential must:

    • Have a negative beta-human chorionic gonadotropin (β-hCG) pregnancy test at time of study entry and within 14 days prior to planned first dose of investigational product, and
    • Agree to use effective contraception until 30 days following the last dose of investigational product and have a male partner who uses a condom or
    • Practice true abstinence or
    • Have a male partner who is vasectomized.
  8. Male subjects with a female partner of childbearing potential must:

    • Be vasectomized, or
    • Agree to use condoms until 30 days following the last dose of investigational product, or
    • Have a female partner who is NOT of childbearing potential.

Exclusion Criteria:

  1. Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study.
  2. Has any other 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. Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit from the diet and all foods that contain those fruits from time of enrollment to while on study.
  4. Is currently taking any prohibited medication(s).
  5. Is unable to take oral medications, malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea or vomiting) that might impair the bioavailability of tazemetostat
  6. Has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  7. For female subjects of childbearing potential: Is pregnant or nursing
  8. Has been permanently discontinued from tazemetostat therapy due to adverse event, intolerance or treatment failure

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


Contacts
Contact: Epizyme 855-500-1011 clinicaltrials@epizyme.com

Locations
United States, Arizona
Recruiting
Tucson, Arizona, United States, 85719
United States, New York
Recruiting
New York, New York, United States, 10038
Australia
Recruiting
Clayton, Australia, 3168
Recruiting
East Melbourne, Australia, 3002
France
Recruiting
Bordeaux, France
Recruiting
Lille, France
Recruiting
Montpellier, France
Recruiting
Pierre-Bénite, France
Recruiting
Rouen, France
Recruiting
Villejuif Cedex, France
United Kingdom
Recruiting
Leicester, United Kingdom
Recruiting
London, United Kingdom
Sponsors and Collaborators
Epizyme, Inc.

Responsible Party: Epizyme, Inc.
ClinicalTrials.gov Identifier: NCT02875548     History of Changes
Other Study ID Numbers: EZH-501
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Synovial
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Mesothelioma
Rhabdoid Tumor
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Neoplasms, Connective and Soft Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms, Mesothelial
Neoplasms, Connective Tissue
Neoplasms, Complex and Mixed
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases