TriangleNCT03107988 · OUTCOME
Pharmacokinetics A2-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 A2
Groups in this outcome
Cohort A2 DL 3A
Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older 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 A2 DL4A
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older 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 A2 DL4A Expansion
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older 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 A2 DL 3A | 2 |
| Cohort A2 DL4A | 3 |
| Cohort A2 DL4A Expansion | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A2 DL 3A | 9217.85 | Not reported | 7267.6 | 11168.1 | Not reported |
| Cohort A2 DL4A | 4492.92 | Not reported | 3993.55 | 5139 | Not reported |
| Cohort A2 DL4A Expansion | 5383.5 | Not reported | 4629.88 | 5747.95 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7267.6
- upper Limit
- 11168.1
- value
- 9217.85
- group Id
- OG001
- lower Limit
- 3993.55
- upper Limit
- 5139
- value
- 4492.92
- group Id
- OG002
- lower Limit
- 4629.88
- upper Limit
- 5747.95
- value
- 5383.5
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- Steady State AUC for lorlatinib in patients in cohort A2
- dispersion Type
- Full Range
- groups
- description
- Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older 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 A2 DL 3A
- description
- Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older 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 A2 DL4A
- description
- Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older 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 A2 DL4A Expansion
- param Type
- MEDIAN
- 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 A2-Steady State AUC
- type
- SECONDARY
- unit Of Measure
- hours*ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice