Clinical trial · Interventional
A Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
A Phase 1 Study of Tazemetostat in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
NCT03009344CI-TRIAL-00062115completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, single-arm, open-label, Phase 1 study to assess the tolerability, safety, pharmacokinetics, and preliminary anti-tumor activity of tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tazemetostat | Drug | Tazemetostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tazemetostat 800 mg
- description
- Participants will receive oral tazemetostat at a starting dose of 800 milligrams (mg) as a single dose (Cycle 0) and 800 mg twice a day as continuous dosing (Cycle 1 and later) (Cycle 0 duration=4 days) (Cycle 1 and later duration= 28 days).
- interventionNames
- Drug: Tazemetostat
Primary outcomes (1)
- measure
- Number of Participants With Dose-limiting Toxicities (DLTs)
- timeFrame
- Cycle 0 and Cycle 1 (Cycle 0=4 days, Cycle 1=28 days)
- description
- DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) were defined as: 1) Grade 4 neutropenia for greater than (\>) 7 days; 2) greater than or equal to (\>=) Grade 3 febrile neutropenia; 3) Grade 4 thrombocytopenia and Grade 3 thrombocytopenia with bleeding; 4) Grade 4 anemia or anemia requiring erythrocyte transfusion; 5) \>=Grade 3 nausea, vomiting, or diarrhea that persisted \>7 days despite maximal medical therapy; 6) \>=Grade 3 non-hematological laboratory abnormalities with clinical symptoms that persisted \>7 days; 7) Other Grade 3 toxicity lasting \>7 days or Grade 4 non-hematological toxicity of any duration; 8) Failure to administer \>=75 percent (%) of the planned administration number of study drug in Cycle 1 as a result of treatment-related toxicity. Here, number of participants who had DLT were reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma * Participant who has measurable disease * Participant who had previous therapy with systemic chemotherapy and/or antibody therapy * Participant who had progressive disease (PD) or did not have a response (complete response \[CR\] or partial response \[PR\]) in previous systemic therapy, or relapsed or progressed after previous systemic therapy * Participant with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Participant with life expectancy of ≥3 months from starting study drug administration * Participant with adequate renal, bone marrow, and liver function * Participant with left ventricular ejection fraction (LVEF) \> 50% * Male and female participant ≥20 years of age at the time of informed consent * Participant who has provided written consent to participate in the study Exclusion Criteria: * Participant with prior exposure to EZH2 inhibitor * Participant with a history or a presence of central nerves invasion * Participant with allogeneic stem cell transplantation * Participant with medical need for the continued use of potent or moderate inhibitors of CYP3A or P-gp, or potent or moderate inducer of CYP3A (including St. John's wort). * Participant with significant cardiovascular impairment * Participant with prolongation of corrected QT interval using Fridericia's formula (QTcF) to \> 480 milliseconds (msec) * Participant with venous thrombosis or pulmonary embolism within the last 3 months before starting study drug * Participant with complications of hepatic cirrhosis, interstitial pneumonia, or pulmonary fibrosis * Participant with active infection requiring systemic therapy * Women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception for periods from before informed consent to during the clinical study and 30 days later from last administration of study drug * Woman who are pregnant or breastfeeding * Participant who were deemed as inappropriate to participate in the study by the investigator or sub-investigator
References
Publications (0)
Data not yet available
No reference posted for this study.