Relapsed or Refractory B-cell Non-Hodgkin's LymphomaPhase 1NCT03009344
A Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
A Phase 1 study testing Tazemetostat in people with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma, run by Eisai Co., Ltd. at 2 sites in Japan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- Tazemetostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesJapan
- Study dates
- 10 Jan 2017to 17 Jun 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1 Study of Tazemetostat in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
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).
- Being tested
- Tazemetostat
- Keywords
- relapsed or refractory B-cell non-Hodgkin's lymphoma, tazemetostat, Japan, E7438
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TazemetostatDrug
Tazemetostat tablets.
| Study group | Role | What they receive |
|---|---|---|
| Tazemetostat 800 mg | Experimental | 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). Receives: Drug: Tazemetostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicities (DLTs)
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.
Measured: Cycle 0 and Cycle 1 (Cycle 0=4 days, Cycle 1=28 days)
Secondary outcomes (25)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE was defined as an adverse event (AE) that emerged during time from first dose to 30 days following last dose of drug, having been absent at pretreatment or reemerged during treatment, having been present at pretreatment but stopped before treatment, or worsened in severity during treatment relative to pretreatment state, when AE was continuous. Number of participants with TEAEs were reported based on their safety assessments of laboratory tests, physical examination, regular measurement of vital signs, body weight, echocardiograms/multigated acquisition (MUGA) scans to assess left ventricular ejection fraction, eastern cooperative oncology group-performance status (ECOG-PS) and electrocardiograms parameter values. SAE was defined as untoward medical occurrence that at any dose resulted in death; was life threatening; resulted in persistent or significant disability; was congenital anomaly or medically important due to other reasons than above mentioned criteria.
Measured: From the date of first dose up to 30 days after the last dose of study drug (up to 40 months)
Cmax: Maximum Plasma Concentration of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
Tmax: Time to Reach Maximum Plasma Concentration (Cmax) of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
AUC(0-12 Hours): Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 0 Day 1: 0-12 hours post-dose (Cycle 0 length=4 days)
AUC(0-t Hours): Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
AUC(0-infinity): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
Lambda z: Terminal Phase Elimination Rate Constant of Tazemetostat and Its Metabolite ER-897387
Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
T1/2: Terminal Half-life of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days); Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
CL/F: Apparent Total Body Clearance of Tazemetostat
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
Vz/F: Apparent Volume of Distribution at Terminal Phase of Tazemetostat
Vz/F for Cycle 0 Day 1 was calculated as Dose divided by ([lambda z]*[AUC0-infinity]) and for Cycle 1 Day 15 was calculated as Dose divided by ([lambda z]*[AUC0-tau]).
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days); Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
MRT: Mean Residence Time of Tazemetostat and Its Metabolite ER-897387
MRT of tazemetostat and its metabolite ER-897387 was calculated as MRT=AUMC(0-infinity)/AUC(0-infinity), where AUMC(0-infinity) was the area under the first moment curve extrapolated to infinity and AUC(0-infinity) was area under the concentration-time curve from zero time extrapolated to infinite time.
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
AUC(0-tau): Area Under the Plasma Concentration-time Curve Over the Dosing Interval of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Css,Av: Average Steady State Plasma Concentration of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Css,Max: Maximum Steady State Plasma Concentration of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Css,Min: Minimum Steady State Plasma Concentration of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
PTF: Peak-trough Fluctuation Ratio of Tazemetostat and Its Metabolite ER-897387
The PTF within complete dosing interval at steady state, calculated as PTF (%) = ([Cmax - Cmin]/Cav) multiplied by 100. Here, Cmin means the minimum plasma concentration, Cmax means the maximum plasma concentration and Cav means the average plasma concentration of drug and metabolite.
Measured: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Tss,Max: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State of Tazemetostat and Its Metabolite ER-897387
Measured: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
CLss/F: Apparent Total Body Clearance of Tazemetostat at Steady State
Measured: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Rac (Cmax): Accumulation Ratio of Cmax for Tazemetostat and Its Metabolite ER-897387
Rac (Cmax) was calculated as the ratio of maximum observed concentration at steady state (Css,max) on Cycle 1 Day 15 divided by Cmax on Cycle 0 Day 1.
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days) and Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Rac (AUC): Accumulation Ratio of AUC for Tazemetostat and Its Metabolite ER-897387
Rac (AUC) was calculated as the ratio of AUC(0-tau) on Cycle 1 Day 15 divided by AUC(0-12 hours) on Cycle 0 Day 1.
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days) and Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Rss: Steady State Accumulation Ratio of Tazemetostat and Its Metabolite ER-897387
Rss was calculated as the ratio of AUC(0-tau) on Cycle 1 Day 15 divided by AUC(0-infinity) on Cycle 0 Day 1.
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days) and Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Ae: Amount of Unchanged Drug Tazemetostat Excreted in Urine
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days); Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Fe: Fraction of Tazemetostat Dose Excreted in Urine
The fraction of dose excreted in urine was calculated as: Cumulative amount of unchanged drug excreted in urine (Ae)/Dose*100.
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days); Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
CLR: Renal Clearance of Tazemetostat
Measured: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days); Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Percentage of Participants With Objective Response
Objective response was assessed by investigator based on the Lugano Classification (CT-Based) response criteria. Objective response rate was defined as the percentage of participants who had a Best Overall Response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From the date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurred first (up to 39 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start10 Jan 2017
- Primary completion12 Jul 2017
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed or Refractory B-cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009344
- Sponsor's protocol ID
- E7438-J081-106
- Status last verified
- Apr 2022
- First submitted
- 30 Dec 2016
- Last updated
- 10 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Tazemetostat in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT03009344
- Acronym / sponsor ID
- E7438-J081-106
- Keywords
- relapsed or refractory B-cell non-Hodgkin's lymphoma, tazemetostat, Japan, E7438
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Posted 10 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tazemetostat 800 mg | Experimental | Drug: TazemetostatParticipants 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TazemetostatTazemetostat tablets. | Drug | Tazemetostat 800 mg |
Primary outcome
Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: Cycle 0 and Cycle 1 (Cycle 0=4 days, Cycle 1=28 days)
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.
25 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From the date of first dose up to 30 days after the last dose of study drug (up to 40 months)
Cmax: Maximum Plasma Concentration of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
Tmax: Time to Reach Maximum Plasma Concentration (Cmax) of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
AUC(0-12 Hours): Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-12 hours post-dose (Cycle 0 length=4 days)
AUC(0-t Hours): Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
AUC(0-infinity): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
Lambda z: Terminal Phase Elimination Rate Constant of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
T1/2: Terminal Half-life of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days); Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
CL/F: Apparent Total Body Clearance of Tazemetostat
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
Vz/F: Apparent Volume of Distribution at Terminal Phase of Tazemetostat
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days); Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
MRT: Mean Residence Time of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days)
AUC(0-tau): Area Under the Plasma Concentration-time Curve Over the Dosing Interval of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Css,Av: Average Steady State Plasma Concentration of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Css,Max: Maximum Steady State Plasma Concentration of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Css,Min: Minimum Steady State Plasma Concentration of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
PTF: Peak-trough Fluctuation Ratio of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Tss,Max: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
CLss/F: Apparent Total Body Clearance of Tazemetostat at Steady State
Time frame: Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Rac (Cmax): Accumulation Ratio of Cmax for Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days) and Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Rac (AUC): Accumulation Ratio of AUC for Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days) and Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Rss: Steady State Accumulation Ratio of Tazemetostat and Its Metabolite ER-897387
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days) and Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Ae: Amount of Unchanged Drug Tazemetostat Excreted in Urine
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days); Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Fe: Fraction of Tazemetostat Dose Excreted in Urine
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days); Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
CLR: Renal Clearance of Tazemetostat
Time frame: Cycle 0 Day 1: 0-72 hours post-dose (Cycle 0 length=4 days); Cycle 1 Day 15: 0-12 hours post-dose (Cycle 1 length=28 days)
Percentage of Participants With Objective Response
Time frame: From the date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurred first (up to 39 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tazemetostat in people with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma, run by Eisai Co., Ltd. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: Cycle 0 and Cycle 1 (Cycle 0=4 days, Cycle 1=28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.