Trial Outcomes & Findings for Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation (NCT NCT03456726)
NCT ID: NCT03456726
Last Updated: 2022-12-16
Results Overview
ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent reviewer assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) was calculated by Clopper-Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Results posted on
2022-12-16
Participant Flow
Participants took part in the study at 28 investigative sites in Japan from 09 April 2018 to 17 December 2021.
A total of 100 participants were screened, of which 80 were screen failures and only 20 participants were eligible to enter the study and received the study treatment.
Participant milestones
| Measure |
Participants With Follicular Lymphoma
Participants with follicular lymphoma (FL) with the enhancer of zeste homolog 2 (EZH2) gene mutation received oral tazemetostat tablet at a starting dose of 800 milligrams (mg) twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until disease progression (PD), development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
Participants with diffuse large B-cell lymphoma (DLBCL) with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
3
|
Reasons for withdrawal
| Measure |
Participants With Follicular Lymphoma
Participants with follicular lymphoma (FL) with the enhancer of zeste homolog 2 (EZH2) gene mutation received oral tazemetostat tablet at a starting dose of 800 milligrams (mg) twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until disease progression (PD), development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
Participants with diffuse large B-cell lymphoma (DLBCL) with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
Overall Study
Disease Progression
|
6
|
1
|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Discontinued from study due to switch to commercial tazemetostat
|
6
|
0
|
Baseline Characteristics
Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation
Baseline characteristics by cohort
| Measure |
Participants With Follicular Lymphoma
n=17 Participants
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=3 Participants
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
74.7 years
STANDARD_DEVIATION 7.23 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 9.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)Population: The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline.
ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent reviewer assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Participants With Follicular Lymphoma
n=17 Participants
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=3 Participants
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
Objective Response Rate (ORR) Based on Independent Reviewer Assessment
|
76.5 percentage of participants
Interval 50.1 to 93.2
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
PRIMARY outcome
Timeframe: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)Population: The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline.
ORR was defined as percentage of participants with confirmed BOR of CR or PR using investigator assessment based on RECIST 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% CI was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Participants With Follicular Lymphoma
n=17 Participants
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=3 Participants
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
ORR Based on Investigator Assessment
|
70.6 percentage of participants
Interval 44.0 to 89.7
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)Population: The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline.
PFS was assessed by independent reviewer assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Outcome measures
| Measure |
Participants With Follicular Lymphoma
n=17 Participants
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=3 Participants
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
Progression-free Survival (PFS) Based on Independent Reviewer Assessment
|
NA months
Interval 12.9 to
Median and upper limit of 95% CI was not estimable due to insufficient PFS events observed.
|
15.7 months
Interval 5.3 to
The upper limit of 95% CI was not estimable due to insufficient PFS events observed.
|
SECONDARY outcome
Timeframe: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)Population: The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline.
PFS was assessed by investigator assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Outcome measures
| Measure |
Participants With Follicular Lymphoma
n=17 Participants
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=3 Participants
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
PFS Based on Investigator Assessment
|
NA months
Interval 18.4 to
Median and upper limit of 95% CI was not estimable due to insufficient PFS events observed.
|
26.7 months
Interval 5.3 to
The upper limit of 95% CI was not estimable due to insufficient PFS events observed.
|
SECONDARY outcome
Timeframe: From the date of first confirmed objective response (OR) to PD or death due to confirmed PR or CR (up to 3 years 4 months)Population: The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Independent Reviewer Assessment.
DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Outcome measures
| Measure |
Participants With Follicular Lymphoma
n=13 Participants
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=3 Participants
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
Duration of Response (DOR) Based on Independent Reviewer Assessment
|
NA months
Interval 11.0 to
Median and upper limit of 95% CI was not estimable due to insufficient number of responders with events observed.
|
13.8 months
Interval 1.6 to
The upper limit of 95% CI was not estimable due to insufficient number of responders with events observed.
|
SECONDARY outcome
Timeframe: From the date of first confirmed OR to PD or death due to any cause for those participants with a confirmed PR or CR (up to 3 years 4 months)Population: The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Investigator Assessment.
DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Outcome measures
| Measure |
Participants With Follicular Lymphoma
n=12 Participants
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=2 Participants
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
DOR Based on Investigator Assessment
|
35.8 months
Interval 22.1 to
The upper limit of 95% CI was not estimable due to insufficient number of responders with events observed.
|
NA months
Interval 21.1 to
The upper limit of 95% CI was not estimable due to insufficient number of responders with events observed.
|
SECONDARY outcome
Timeframe: From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months)Population: The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Independent Reviewer Assessment.
TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using independent reviewer assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.
Outcome measures
| Measure |
Participants With Follicular Lymphoma
n=13 Participants
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=3 Participants
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
Time to Response (TTR) Based on Independent Reviewer Assessment
|
3.64 months
Interval 1.8 to 10.1
|
3.70 months
Interval 1.9 to 7.4
|
SECONDARY outcome
Timeframe: From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months)Population: The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Investigator Assessment.
TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using investigator assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.
Outcome measures
| Measure |
Participants With Follicular Lymphoma
n=12 Participants
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=2 Participants
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
TTR Based on Investigator Assessment
|
4.59 months
Interval 1.8 to 7.5
|
5.56 months
Interval 5.5 to 5.6
|
SECONDARY outcome
Timeframe: From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)Population: The safety analysis set included participants who received at least 1 administration of the study drug.
TEAE is defined as an AE that emerged during time from the first dose of study drug to 30 days after the participant's last dose. An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Outcome measures
| Measure |
Participants With Follicular Lymphoma
n=17 Participants
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=3 Participants
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
17 Participants
|
3 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
8 Participants
|
1 Participants
|
Adverse Events
Participants With Follicular Lymphoma
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Participants With Diffuse Large B-cell Lymphoma
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Follicular Lymphoma
n=17 participants at risk
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=3 participants at risk
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
Gastrointestinal disorders
Mechanical ileus
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
General disorders
Pyrexia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Atypical pneumonia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Periodontitis
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
Other adverse events
| Measure |
Participants With Follicular Lymphoma
n=17 participants at risk
Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
Participants With Diffuse Large B-cell Lymphoma
n=3 participants at risk
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|---|---|---|
|
Nervous system disorders
Sciatica
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
29.4%
5/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.6%
3/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.6%
3/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Cardiac disorders
Pericardial effusion
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Eye disorders
Conjunctival haemorrhage
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Eye disorders
Cataract
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Eye disorders
Visual impairment
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Gastrointestinal disorders
Constipation
|
29.4%
5/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Gastrointestinal disorders
Stomatitis
|
29.4%
5/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Gastrointestinal disorders
Epigastric discomfort
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Gastrointestinal disorders
Haematochezia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Gastrointestinal disorders
Large intestine polyp
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Gastrointestinal disorders
Tooth disorder
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
General disorders
Fatigue
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
General disorders
Malaise
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
General disorders
Oedema peripheral
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
General disorders
Pyrexia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Immune system disorders
Hypogammaglobulinaemia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Nasopharyngitis
|
41.2%
7/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
29.4%
5/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Herpes simplex
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Influenza
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Pneumonia
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Urinary tract infection
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Gastroenteritis
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Impetigo
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Oral herpes
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Paronychia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Periodontitis
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
29.4%
5/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Blood creatinine increased
|
17.6%
3/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Weight decreased
|
17.6%
3/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Amylase increased
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Electrocardiogram QT prolonged
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Blood pressure decreased
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Blood zinc decreased
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Investigations
Immature granulocyte count increased
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Nervous system disorders
Dysgeusia
|
52.9%
9/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Nervous system disorders
Muscle spasticity
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Nervous system disorders
Visual field defect
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Renal and urinary disorders
Haematuria
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Renal and urinary disorders
Hypertonic bladder
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.5%
4/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.8%
2/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
33.3%
1/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
|
Vascular disorders
Phlebitis
|
5.9%
1/17 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
0.00%
0/3 • From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place