Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02875548
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02875548
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Epizyme, Inc.

Tracking Information
First Submitted Date  ICMJE August 5, 2016
First Posted Date  ICMJE August 23, 2016
Last Update Posted Date January 10, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02875548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 17, 2016)
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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Tazemetostat Rollover Study (TRuST): An Open-Label Rollover Study
Official Title  ICMJE Tazemetostat Rollover Study (TRuST): An Open-Label Rollover Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: Tazemetostat
Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.
Other Names:
  • EPZ-6438
  • E7438
Study Arms  ICMJE 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.
Intervention: Drug: Tazemetostat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 unless approved by Medical Monitor.
  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. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE 4.03 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
  4. Has a prior history of T-LBL/T-ALL.
  5. 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.
  6. Is currently taking any prohibited medication(s).
  7. 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
  8. Has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  9. For female subjects of childbearing potential: Is pregnant or nursing
  10. Has been permanently discontinued from tazemetostat therapy due to adverse event, intolerance or treatment failure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Epizyme 855-500-1011 clinicaltrials@epizyme.com
Listed Location Countries  ICMJE Australia,   France,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02875548
Other Study ID Numbers  ICMJE EZH-501
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Epizyme, Inc.
Study Sponsor  ICMJE Epizyme, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Epizyme, Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP