TriangleNCT03107988 · OUTCOME
Pharmacokinetics A1 and B1-Steady State AUC
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours*ng/mL
- Interval / dispersion
- Full Range
- Time frame
- Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose)
What was measured
Steady State AUC for lorlatinib in patients in cohort A1 and B1
Analysis population: No AUCtau is included for patients in Cohort B1DL5 as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable.
Groups in this outcome
Cohort A1 DL1
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cohort A1 DL2
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cohort A1 DL3
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cohort A1 DL4
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
| Group | Source count |
|---|---|
| Cohort A1 DL1 | 2 |
| Cohort A1 DL2 | 1 |
| Cohort A1 DL3 | 1 |
| Cohort A1 DL4 | 6 |
| Cohort A1 DL5 | 3 |
| Cohort B1 DL5 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A1 DL1 | 1872 | Not reported | 1074.93 | 2669.08 | Not reported |
| Cohort A1 DL2 | 2663.49 | Not reported | 2663.49 | 2663.49 | Not reported |
| Cohort A1 DL3 | 2084.81 | Not reported | 2084.81 | 2084.81 | Not reported |
| Cohort A1 DL4 | 7431.06 | Not reported | 3021.81 | 8906.31 | Not reported |
| Cohort A1 DL5 | 5655.05 | Not reported | 4724.92 | 10910.87 | Not reported |
| Cohort B1 DL5 | NA | Not reported | NA | NA | No AUCtau is included for patients in Cohort B1DL5 as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1074.93
- upper Limit
- 2669.08
- value
- 1872
- group Id
- OG001
- lower Limit
- 2663.49
- upper Limit
- 2663.49
- value
- 2663.49
- group Id
- OG002
- lower Limit
- 2084.81
- upper Limit
- 2084.81
- value
- 2084.81
- group Id
- OG003
- lower Limit
- 3021.81
- upper Limit
- 8906.31
- value
- 7431.06
- group Id
- OG004
- lower Limit
- 4724.92
- upper Limit
- 10910.87
- value
- 5655.05
- comment
- No AUCtau is included for patients in Cohort B1DL5 as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- units
- Participants
- description
- Steady State AUC for lorlatinib in patients in cohort A1 and B1
- dispersion Type
- Full Range
- groups
- description
- Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
- id
- OG000
- title
- Cohort A1 DL1
- description
- Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
- id
- OG001
- title
- Cohort A1 DL2
- description
- Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
- id
- OG002
- title
- Cohort A1 DL3
- description
- Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
- id
- OG003
- title
- Cohort A1 DL4
- description
- Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
- id
- OG004
- title
- Cohort A1 DL5
- description
- Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
- id
- OG005
- title
- Cohort B1 DL5
- param Type
- MEDIAN
- population Description
- No AUCtau is included for patients in Cohort B1DL5 as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable.
- reporting Status
- POSTED
- time Frame
- Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose)
- title
- Pharmacokinetics A1 and B1-Steady State AUC
- type
- SECONDARY
- unit Of Measure
- hours*ng/mL
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Preserved source evidence · Independent clinical review pending · Not medical advice