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Trial record 1 of 1 for:    NCT03456726
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Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation

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ClinicalTrials.gov Identifier: NCT03456726
Recruitment Status : Active, not recruiting
First Posted : March 7, 2018
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
This is a multicenter, open-label, Phase 2 study to assess the efficacy and safety of tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) with EZH2 gene mutation.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma Drug: Tazemetostat Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Tazemetostat in Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : December 2, 2020
Estimated Study Completion Date : October 2021


Arm Intervention/treatment
Experimental: FL with EZH2 gene mutation
Participants with follicular lymphoma (FL) with the EZH2 gene mutation will receive oral tazemetostat at a starting dose of 800 milligrams (mg) twice daily (1600 mg total daily dose) by continuous regimen, no less than 8 hours between doses.
Drug: Tazemetostat
Tazemetostat will be provided as a 200 mg oral tablet.

Experimental: DLBCL with EZH2 gene mutation
Participants with diffuse large B-cell lymphoma (DLBCL) with the EZH2 gene mutation will receive oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) by continuous regimen, no less than 8 hours between doses.
Drug: Tazemetostat
Tazemetostat will be provided as a 200 mg oral tablet.




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: From administration of the first dose of the study drug until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent, or study termination (up to 30 months) ]
    ORR is defined as the number of participants with a best overall response of complete response or partial response.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: From administration of the first dose of the study drug to the date of the first event (disease progression, death, etc.) (up to 30 months) ]
  2. Duration of response (DOR) [ Time Frame: From confirmation of the first response to the date of the first event (disease progression, death, etc.) (up to 30 months) ]
  3. Time to response (TTR) [ Time Frame: From administration of the first dose of the study drug to confirmation of the first response (up to 30 months) ]
  4. Number of participants with any adverse event, as an assessment of safety [ Time Frame: From administration of the first dose of the study drug to 30 days after the last dose (up to 30 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma (NHL) as follows:

    • Cohort 1: Follicular lymphoma (FL)
    • Cohort 2: Diffuse large B-cell lymphoma (including primary mediastinal B-cell lymphoma and transformed FL)
  • Participants who have confirmed EZH2 gene mutation of tumor in central laboratory
  • Participants who have measurable disease
  • Participants who had previous therapy with systemic chemotherapy and/or antibody therapy and for which no standard therapy exists
  • Participants who had progressive disease or did not have response (complete response or partial response) in previous systemic therapy, or relapsed or progressed after previous systemic therapy
  • Participants with Eastern Cooperative Oncology Group performance status of 0 to 1
  • Participants with life expectancy of ≥3 months from starting study drug administration
  • Participants with adequate renal, liver, and bone marrow function
  • Male and female participants ≥20 years of age at the time of informed consent
  • Participants who has provided written consent to participate in the study

Exclusion Criteria:

  • Participants with prior exposure to EZH2 inhibitor
  • Participants with a history or a presence of central nerves invasion
  • Participants with malignant pleural effusion, cardiac effusion, or ascites retention
  • Participants with allogeneic stem cell transplantation
  • Participants with medical need for the continued use of potent inhibitors of Cytochrome P450 3A (CYP3A)or potent inducer of CYP3A (including St. John's wort)
  • Participants with significant cardiovascular impairment

    · Participants with prolongation of corrected QT interval using Fridericia's formula to > 480 milliseconds (msec)

  • Participants with venous thrombosis or pulmonary embolism within the last 3 months before starting study drug
  • Participants with complications of hepatic cirrhosis, interstitial pneumonia or pulmonary fibrosis
  • Participants with active infection requiring systemic therapy
  • Women of childbearing potential or man of impregnate potential who don't agree that both the participant and his/her partner will use a medically effective method for contraception for periods from before informed consent to during the clinical study and 30 days later (for males 90 days later) from last administration of study drug
  • Woman who are pregnant or breastfeeding
  • Participants who were deemed as inappropriate to participate in the study by the investigator or sub-investigator
  • Have any prior history of T-cell lymphoblastic lymphoma/T-cell acute lymphoblastic leukemia or myeloid malignancies, including myelodysplastic syndrome

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): NCT03456726


Locations
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Sponsors and Collaborators
Eisai Co., Ltd.
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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03456726    
Other Study ID Numbers: E7438-J081-206
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
EZH2 gene mutation
Tazemetostat
Diffuse large B-cell lymphoma
Follicular lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases