Trial Outcomes & Findings for Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients (NCT NCT03028103)
NCT ID: NCT03028103
Last Updated: 2023-06-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Days 15 and 19, 0 to 8 hours post-dose
Results posted on
2023-06-26
Participant Flow
Participant milestones
| Measure |
Part A
Subjects enrolled in Part A received treatment with oral tazemetostat tablets 400 mg twice daily for 24 days beginning on Day 1. Blood samples for the analysis of plasma tazemetostat and its metabolites concentrations were collected predose and over 8 hours after the morning dose of tazemetostat on Day 15. Subjects received fluconazole 400 mg once daily for 4 days starting on Day 16. On Day 19, blood samples for the analysis of plasma tazemetostat, its metabolites, and fluconazole were collected predose and over 8 hours after the morning tazemetostat dose. Tazemetostat 400 mg twice daily continued through Day 24. Subjects then received tazemetostat 800 mg twice daily starting on Day 25.
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Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
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|---|---|---|
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Overall Study
STARTED
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16
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16
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Overall Study
COMPLETED
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16
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16
|
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients
Baseline characteristics by cohort
| Measure |
Part A
n=16 Participants
Subjects enrolled in Part A received treatment with oral tazemetostat tablets 400 mg twice daily for 24 days beginning on Day 1. Blood samples for the analysis of plasma tazemetostat and its metabolites concentrations were collected predose and over 8 hours after the morning dose of tazemetostat on Day 15. Subjects received fluconazole 400 mg once daily for 4 days starting on Day 16. On Day 19, blood samples for the analysis of plasma tazemetostat, its metabolites, and fluconazole were collected predose and over 8 hours after the morning tazemetostat dose. Tazemetostat 400 mg twice daily continued through Day 24. Subjects then received tazemetostat 800 mg twice daily starting on Day 25.
|
Part B
n=16 Participants
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
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Total
n=32 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
62.9 Years
STANDARD_DEVIATION 15.10 • n=5 Participants
|
48.8 Years
STANDARD_DEVIATION 17.75 • n=7 Participants
|
55.8 Years
STANDARD_DEVIATION 17.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
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2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 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
|
|
Region of Enrollment
United States
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16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
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Baseline Disease Characteristics and Prior Therapies
Lymphoma
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10 Participants
n=5 Participants
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3 Participants
n=7 Participants
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13 Participants
n=5 Participants
|
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Baseline Disease Characteristics and Prior Therapies
Advanced Solid tumors
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6 Participants
n=5 Participants
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13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Baseline Disease Characteristics and Prior Therapies
Stage at diagnosis: I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Disease Characteristics and Prior Therapies
Stage at diagnosis: II
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Baseline Disease Characteristics and Prior Therapies
Stage at diagnosis: III
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5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
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8 Participants
n=5 Participants
|
|
Baseline Disease Characteristics and Prior Therapies
Stage at diagnosis: IV
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8 Participants
n=5 Participants
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10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Baseline Disease Characteristics and Prior Therapies
Stage at diagnosis: Unknown
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2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Baseline Disease Characteristics and Prior Therapies
Progressive disease prior to study entry
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16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 15 and 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
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Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
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Part A: Effect of CYP3A Inhibition by Fluconazole on the PK of Tazemetostat (AUC0-t, AUC0-8)
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ-6438
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1340 h*ng/mL
Standard Deviation 1180
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—
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Part A: Effect of CYP3A Inhibition by Fluconazole on the PK of Tazemetostat (AUC0-t, AUC0-8)
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ-6438
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4100 h*ng/mL
Standard Deviation 2680
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—
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PRIMARY outcome
Timeframe: Days 15 and 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
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Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
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Part A: Cmax of Tazemetostat During Co-administration With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ-6438
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426 ng/mL
Standard Deviation 337
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—
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Part A: Cmax of Tazemetostat During Co-administration With Fluconazole
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ-6438
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968 ng/mL
Standard Deviation 801
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—
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PRIMARY outcome
Timeframe: Days 1 and 16, 0 to 8 hours post-dosePopulation: In Part B, 13 subjects completed taking omeprazole and repaglinide on Day 1, with tazemetostat on Day 16 and 11 subjects completed taking tazemetostat alone on Day 19.
Outcome measures
| Measure |
Part A
n=13 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
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Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
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Part B: The Potential of Tazemetostat to Inhibit or Induce CYP2C8 Using Repaglinide as a Probe Substrate (AUC0-t, AUC0-∞)
Part: B; Day 1; Treatment: Repaglinide Alone; Analyte: Repaglinide - AUC(0-t)
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8.16 h*ng/mL
Standard Deviation 13.7
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—
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Part B: The Potential of Tazemetostat to Inhibit or Induce CYP2C8 Using Repaglinide as a Probe Substrate (AUC0-t, AUC0-∞)
Part: B; Day 16; Treatment: Repaglinide with Tazemetostat; Analyte: Repaglinide - AUC(0-t)
|
14.7 h*ng/mL
Standard Deviation 15.1
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—
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Part B: The Potential of Tazemetostat to Inhibit or Induce CYP2C8 Using Repaglinide as a Probe Substrate (AUC0-t, AUC0-∞)
Part: B; Day 1; Treatment: Repaglinide Alone; Analyte: Repaglinide - AUC(0-∞)
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12.7 h*ng/mL
Standard Deviation 19.4
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—
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Part B: The Potential of Tazemetostat to Inhibit or Induce CYP2C8 Using Repaglinide as a Probe Substrate (AUC0-t, AUC0-∞)
Part: B; Day 16; Treatment: Repaglinide with Tazemetostat; Analyte: Repaglinide - AUC(0-∞)
|
17 h*ng/mL
Standard Deviation 15.7
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—
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PRIMARY outcome
Timeframe: Days 1 and 16, 0 to 8 hours post-dosePopulation: In Part B, 13 subjects completed taking omeprazole and repaglinide on Day 1, with tazemetostat on Day 16 and 11 subjects completed taking tazemetostat alone on Day 19.
Outcome measures
| Measure |
Part A
n=13 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
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Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
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Part B: Cmax of Repaglinide During Co-administration With Tazemetostat
Part: B; Day 1; Treatment: Repaglinide Alone; Analyte: Repaglinide
|
5.14 ng/mL
Standard Deviation 8.28
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—
|
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Part B: Cmax of Repaglinide During Co-administration With Tazemetostat
Part: B; Day 16; Treatment: Repaglinide with Tazemetostat; Analyte: Repaglinide
|
7.75 ng/mL
Standard Deviation 8.73
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—
|
PRIMARY outcome
Timeframe: Days 1 and 16, 0 to 8 hours post-dosePopulation: In Part B, 13 subjects completed taking omeprazole and repaglinide on Day 1, with tazemetostat on Day 16 and 11 subjects completed taking tazemetostat alone on Day 19.
Outcome measures
| Measure |
Part A
n=13 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
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Part B: The Potential of Tazemetostat to Inhibit or Induce CYP2C19 Using Omeprazole as Probe a Substrate (AUC0-t, AUC0-∞)
Part: B; Day 1; Treatment: Omeprazole Alone; Analyte: Omeprazole - AUC(0-t)
|
600 h*ng/mL
Standard Deviation 1600
|
—
|
|
Part B: The Potential of Tazemetostat to Inhibit or Induce CYP2C19 Using Omeprazole as Probe a Substrate (AUC0-t, AUC0-∞)
Part: B; Day 16; Treatment: Omeprazole with Tazemetostat; Analyte: Omeprazole - AUC(0-t)
|
480 h*ng/mL
Standard Deviation 837
|
—
|
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Part B: The Potential of Tazemetostat to Inhibit or Induce CYP2C19 Using Omeprazole as Probe a Substrate (AUC0-t, AUC0-∞)
Part: B; Day 1; Treatment: Omeprazole Alone; Analyte: Omeprazole - AUC(0-∞)
|
672 h*ng/mL
Standard Deviation 463
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—
|
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Part B: The Potential of Tazemetostat to Inhibit or Induce CYP2C19 Using Omeprazole as Probe a Substrate (AUC0-t, AUC0-∞)
Part: B; Day 16; Treatment: Omeprazole with Tazemetostat; Analyte: Omeprazole - AUC(0-∞)
|
1120 h*ng/mL
Standard Deviation 1530
|
—
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PRIMARY outcome
Timeframe: Days 1 and 16, 0 to 8 hours post-dosePopulation: In Part B, 13 subjects completed taking omeprazole and repaglinide on Day 1, with tazemetostat on Day 16 and 11 subjects completed taking tazemetostat alone on Day 19.
Outcome measures
| Measure |
Part A
n=13 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
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|---|---|---|
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Part B: Cmax of Omeprazole During Co-administration With Tazemetostat
Part: B; Day 1; Treatment: Omeprazole Alone; Analyte: Omeprazole
|
253 ng/mL
Standard Deviation 462
|
—
|
|
Part B: Cmax of Omeprazole During Co-administration With Tazemetostat
Part: B; Day 16; Treatment: Omeprazole with Tazemetostat; Analyte: Omeprazole
|
207 ng/mL
Standard Deviation 275
|
—
|
PRIMARY outcome
Timeframe: Days 16 and 19, 0 to 8 hours post-dosePopulation: In Part B, 13 subjects completed taking omeprazole and repaglinide on Day 1, with tazemetostat on Day 16 and 11 subjects completed taking tazemetostat alone on Day 19.
Outcome measures
| Measure |
Part A
n=13 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
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Part B: Effect of Increased Gastric pH by Omeprazole on the PK of Tazemetostat (AUC0-t, AUC0-8)
Part: B; Day 16; Treatment: Omeprazole with Tazemetostat; Analyte: EPZ-6438 - AUC(0-t)
|
1780 h*ng/mL
Standard Deviation 2010
|
—
|
|
Part B: Effect of Increased Gastric pH by Omeprazole on the PK of Tazemetostat (AUC0-t, AUC0-8)
Part: B; Day 19; Treatment: Tazemetostat Alone; Analyte: EPZ-6438 - AUC(0-t)
|
2150 h*ng/mL
Standard Deviation 1030
|
—
|
PRIMARY outcome
Timeframe: Days 16 and 19, 0 to 8 hours post-dosePopulation: In Part B, 13 subjects completed taking omeprazole and repaglinide on Day 1, with tazemetostat on Day 16 and 11 subjects completed taking tazemetostat alone on Day 19.
Outcome measures
| Measure |
Part A
n=13 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Part B: Cmax of Tazemetostat During Co-administration With Omeprazole
Part: B; Day 16; Treatment: Omeprazole with Tazemetostat; Analyte: EPZ-6438
|
521 ng/mL
Standard Deviation 627
|
—
|
|
Part B: Cmax of Tazemetostat During Co-administration With Omeprazole
Part: B; Day 19; Treatment: Tazemetostat Alone; Analyte: EPZ-6438
|
641 ng/mL
Standard Deviation 404
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study treatment until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, up to 2 years.Outcome measures
| Measure |
Part A
n=16 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
n=16 Participants
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Incidence of Treatment-emergent Adverse Events as a Measure of Safety
Any TEAE
|
12 Participants
|
14 Participants
|
|
Incidence of Treatment-emergent Adverse Events as a Measure of Safety
Any TEAE Grade 3 or 4
|
7 Participants
|
8 Participants
|
|
Incidence of Treatment-emergent Adverse Events as a Measure of Safety
Any Treatment-Related TEAE
|
9 Participants
|
10 Participants
|
|
Incidence of Treatment-emergent Adverse Events as a Measure of Safety
Any Treatment-Related TEAE Grade 3 or 4
|
4 Participants
|
3 Participants
|
|
Incidence of Treatment-emergent Adverse Events as a Measure of Safety
Any TEAE Leading to Dose Reduction
|
2 Participants
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events as a Measure of Safety
Any TEAE Leading to Study Drug Interruption
|
3 Participants
|
6 Participants
|
|
Incidence of Treatment-emergent Adverse Events as a Measure of Safety
Any TEAE Leading to Study Drug Discontinuation
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events as a Measure of Safety
Any TESAE
|
4 Participants
|
6 Participants
|
|
Incidence of Treatment-emergent Adverse Events as a Measure of Safety
Any Treatment-Related TESAE
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events as a Measure of Safety
Any Protocol Defined AE of Special Interest
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 15 and 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Part A: PK of Tazemetostat and Its Metabolites After Administration Alone and With Fluconazole (AUC0-t, AUC0-8)
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ-6930 (ER-897387)
|
2590 h*ng/mL
Standard Deviation 1200
|
—
|
|
Part A: PK of Tazemetostat and Its Metabolites After Administration Alone and With Fluconazole (AUC0-t, AUC0-8)
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ-6930 (ER-897387)
|
2860 h*ng/mL
Standard Deviation 1600
|
—
|
|
Part A: PK of Tazemetostat and Its Metabolites After Administration Alone and With Fluconazole (AUC0-t, AUC0-8)
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ006931
|
770 h*ng/mL
Standard Deviation 630
|
—
|
|
Part A: PK of Tazemetostat and Its Metabolites After Administration Alone and With Fluconazole (AUC0-t, AUC0-8)
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ006931
|
921 h*ng/mL
Standard Deviation 780
|
—
|
|
Part A: PK of Tazemetostat and Its Metabolites After Administration Alone and With Fluconazole (AUC0-t, AUC0-8)
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ034163
|
276 h*ng/mL
Standard Deviation 415
|
—
|
|
Part A: PK of Tazemetostat and Its Metabolites After Administration Alone and With Fluconazole (AUC0-t, AUC0-8)
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ034163
|
295 h*ng/mL
Standard Deviation 430
|
—
|
SECONDARY outcome
Timeframe: Days 15 and 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Part A: Tmax of Tazemetostat After Administration Alone and With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ-6438
|
1.13 hours
Standard Deviation 0.87
|
—
|
|
Part A: Tmax of Tazemetostat After Administration Alone and With Fluconazole
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ-6438
|
2 hours
Standard Deviation 0.84
|
—
|
SECONDARY outcome
Timeframe: Days 15 and 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Part A: t1/2 of Tazemetostat After Administration Alone and With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ-6438
|
2.88 hours
Standard Deviation 0.491
|
—
|
|
Part A: t1/2 of Tazemetostat After Administration Alone and With Fluconazole
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ-6438
|
3.56 hours
Standard Deviation 0.453
|
—
|
SECONDARY outcome
Timeframe: Days 15 and 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Part A: Cmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ-6930 (ER-897387)
|
629 ng/mL
Standard Deviation 270
|
—
|
|
Part A: Cmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ-6930 (ER-897387)
|
548 ng/mL
Standard Deviation 288
|
—
|
|
Part A: Cmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ006931
|
166 ng/mL
Standard Deviation 105
|
—
|
|
Part A: Cmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ034163
|
46 ng/mL
Standard Deviation 56.7
|
—
|
|
Part A: Cmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ034163
|
47.1 ng/mL
Standard Deviation 61.4
|
—
|
|
Part A: Cmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ006931
|
167 ng/mL
Standard Deviation 153
|
—
|
SECONDARY outcome
Timeframe: Days 15 and 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Part A: Tmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ-6930 (ER-897387)
|
2.01 hours
Standard Deviation 0.65
|
—
|
|
Part A: Tmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ-6930 (ER-897387)
|
2.02 hours
Standard Deviation 0.86
|
—
|
|
Part A: Tmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ006931
|
2.01 hours
Standard Deviation 0.89
|
—
|
|
Part A: Tmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ006931
|
2.47 hours
Standard Deviation 0.9
|
—
|
|
Part A: Tmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ034163
|
2.02 hours
Standard Deviation 1.26
|
—
|
|
Part A: Tmax of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ034163
|
2.02 hours
Standard Deviation 1.27
|
—
|
SECONDARY outcome
Timeframe: Days 15 and 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Part A: t1/2 of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ-6930 (ER-897387)
|
2.89 hours
Standard Deviation 0.358
|
—
|
|
Part A: t1/2 of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 19; Treatment: Tazemetostat with Fluconazole; Analyte: EPZ-6930 (ER-897387)
|
3.92 hours
Standard Deviation 0.621
|
—
|
|
Part A: t1/2 of Tazemetostat Metabolites After Administration Alone and With Fluconazole
Part: A; Day 15; Treatment: Tazemetostat Alone; Analyte: EPZ006931
|
3.24 hours
Standard Deviation 0.565
|
—
|
SECONDARY outcome
Timeframe: Day 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Part A: Exposure of Fluconazole After Administration of 400 mg Once Daily for 4 Days (AUC0-8)
|
170000 h*ng/mL
Standard Deviation 48300
|
—
|
SECONDARY outcome
Timeframe: Day 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Part A: Cmax of Fluconazole After Administration of 400mg Once Daily for 4 Days
|
25900 ng/mL
Standard Deviation 6500
|
—
|
SECONDARY outcome
Timeframe: Day 19, 0 to 8 hours post-doseOutcome measures
| Measure |
Part A
n=14 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
Part A: Tmax of Fluconazole After Administration of 400mg Once Daily for 4 Days
|
1.48 hours
Standard Deviation 1.95
|
—
|
SECONDARY outcome
Timeframe: Within 28 days of Day 1, 8 weeks, 16 weeks, 24 weeksObjective response rate (ORR: complete response \[CR\] or PR) and disease control rate (DCR: CR or PR, or stable disease lasting 24 weeks or longer from start of treatment with tazemetostat) using Lugano Classification for subjects with lymphoma, or Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for subjects with solid tumors.
Outcome measures
| Measure |
Part A
n=13 Participants
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
n=16 Participants
Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
|
|---|---|---|
|
The Antitumor Activity of Tazemetostat Will be Assessed in Patients With Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL) or Advanced Solid Tumors .
Complete response (CR)
|
1 Participants
|
0 Participants
|
|
The Antitumor Activity of Tazemetostat Will be Assessed in Patients With Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL) or Advanced Solid Tumors .
Partial response (PR)
|
1 Participants
|
2 Participants
|
|
The Antitumor Activity of Tazemetostat Will be Assessed in Patients With Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL) or Advanced Solid Tumors .
Stable disease (SD)
|
0 Participants
|
9 Participants
|
|
The Antitumor Activity of Tazemetostat Will be Assessed in Patients With Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL) or Advanced Solid Tumors .
Progressive disease (PD)
|
2 Participants
|
5 Participants
|
|
The Antitumor Activity of Tazemetostat Will be Assessed in Patients With Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL) or Advanced Solid Tumors .
Not evaluable, missing, or unknown
|
9 Participants
|
3 Participants
|
|
The Antitumor Activity of Tazemetostat Will be Assessed in Patients With Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL) or Advanced Solid Tumors .
Objective Response Rate (ORR)
|
2 Participants
|
2 Participants
|
|
The Antitumor Activity of Tazemetostat Will be Assessed in Patients With Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL) or Advanced Solid Tumors .
Disease control rate (DCR) at 24 weeks
|
2 Participants
|
4 Participants
|
|
The Antitumor Activity of Tazemetostat Will be Assessed in Patients With Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL) or Advanced Solid Tumors .
Number of responders (achieving a CR or PR)
|
2 Participants
|
2 Participants
|
Adverse Events
Part A
Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths
Part B
Serious events: 6 serious events
Other events: 14 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part A
n=16 participants at risk
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
n=16 participants at risk
Part B: Subjects enrolled in Part B will receive single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg BID will begin on Day 2. On Day 16, subjects again will receive single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also will receive omeprazole 20 mg once daily in the morning on Days 16 through 19.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Herpes zoster
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
Platelet count decreased
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
Other adverse events
| Measure |
Part A
n=16 participants at risk
Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
|
Part B
n=16 participants at risk
Part B: Subjects enrolled in Part B will receive single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg BID will begin on Day 2. On Day 16, subjects again will receive single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also will receive omeprazole 20 mg once daily in the morning on Days 16 through 19.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
37.5%
6/16 • Adverse Events were collected over a period of 2 years.
|
18.8%
3/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
4/16 • Adverse Events were collected over a period of 2 years.
|
25.0%
4/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • Adverse Events were collected over a period of 2 years.
|
18.8%
3/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
25.0%
4/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Eructation
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
General disorders
Fatigue
|
37.5%
6/16 • Adverse Events were collected over a period of 2 years.
|
50.0%
8/16 • Adverse Events were collected over a period of 2 years.
|
|
General disorders
Asthenia
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
General disorders
Influenza like illness
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
General disorders
Mucosal inflammation
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
General disorders
Oedema peripheral
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
General disorders
Face oedema
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
General disorders
Generalised oedema
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
General disorders
Pain
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
General disorders
Pyrexia
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Nervous system disorders
Balance disorder
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Nervous system disorders
Brain compression
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Fungal skin infection
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Viral rash
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Otitis media
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Eye disorders
Diplopia
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Eye disorders
Ocular discomfort
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Eye disorders
Photophobia
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Eye disorders
Macular oedema
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Immune system disorders
Seasonal allergy
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
Blood creatinine increased
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
Blood immunoglobulin G decreased
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
Weight increased
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
|
Reproductive system and breast disorders
Testicular swelling
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
12.5%
2/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Vascular disorders
Hot flush
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16 • Adverse Events were collected over a period of 2 years.
|
6.2%
1/16 • Adverse Events were collected over a period of 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place