TriangleNCT04148937 · OUTCOME
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Eight Hours (AUC[0-8]) of LY3475070
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanograms*hours per milliliter (ng*h/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose)
What was measured
PK: AUC\[0-8\] of LY3475070.
Analysis population: All enrolled participants in phase1a who received LY3475070 and had intensively sampled evaluable PK data on cycle 1 day 1.
Groups in this outcome
Cohort A - 150mg QD LY3475070
Participants received 150mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
Cohort A - 300mg QD LY3475070
Participants received 300mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
Cohort A - 300mg BID LY3475070
Participants received 300mg LY3475070 orally twice daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
Cohort A - 600mg QD LY3475070
Participants received 600mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
Cohort B - 150mg QD LY3475070 + Pembrolizumab
Participants received 150mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
Cohort B - 150mg BID LY3475070 + Pembrolizumab
Participants received 150mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
Cohort B - 300mg QD LY3475070 + Pembrolizumab
Participants received 300mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
Cohort B - 300mg BID LY3475070 + Pembrolizumab
Participants received 300mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study
| Group | Source count |
|---|---|
| Cohort A - 150mg QD LY3475070 | 4 |
| Cohort A - 300mg QD LY3475070 | 6 |
| Cohort A - 300mg BID LY3475070 | 5 |
| Cohort A - 600mg QD LY3475070 | 4 |
| Cohort B - 150mg QD LY3475070 + Pembrolizumab | 3 |
| Cohort B - 150mg BID LY3475070 + Pembrolizumab | 7 |
| Cohort B - 300mg QD LY3475070 + Pembrolizumab | 1 |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A - 150mg QD LY3475070 | 5880 | 38.7 | Not reported | Not reported | Not reported |
| Cohort A - 300mg QD LY3475070 | 6580 | 83.2 | Not reported | Not reported | Not reported |
| Cohort A - 300mg BID LY3475070 | 10700 | 93.3 | Not reported | Not reported | Not reported |
| Cohort A - 600mg QD LY3475070 | 16000 | 43.9 | Not reported | Not reported | Not reported |
| Cohort B - 150mg QD LY3475070 + Pembrolizumab | 2990 | 57.4 | Not reported | Not reported | Not reported |
| Cohort B - 150mg BID LY3475070 + Pembrolizumab | 3680 | 65.8 | Not reported | Not reported | Not reported |
| Cohort B - 300mg QD LY3475070 + Pembrolizumab | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 12600 ng\*h/mL |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 8960 | 43.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 38.7
- value
- 5880
- group Id
- OG001
- spread
- 83.2
- value
- 6580
- group Id
- OG002
- spread
- 93.3
- value
- 10700
- group Id
- OG003
- spread
- 43.9
- value
- 16000
- group Id
- OG004
- spread
- 57.4
- value
- 2990
- group Id
- OG005
- spread
- 65.8
- value
- 3680
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 12600 ng\*h/mL
- group Id
- OG006
- spread
- NA
- value
- NA
- group Id
- OG007
- spread
- 43.4
- value
- 8960
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 13
- units
- Participants
- description
- PK: AUC\[0-8\] of LY3475070.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received 150mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- OG000
- title
- Cohort A - 150mg QD LY3475070
- description
- Participants received 300mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- OG001
- title
- Cohort A - 300mg QD LY3475070
- description
- Participants received 300mg LY3475070 orally twice daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- OG002
- title
- Cohort A - 300mg BID LY3475070
- description
- Participants received 600mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- OG003
- title
- Cohort A - 600mg QD LY3475070
- description
- Participants received 150mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- OG004
- title
- Cohort B - 150mg QD LY3475070 + Pembrolizumab
- description
- Participants received 150mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- OG005
- title
- Cohort B - 150mg BID LY3475070 + Pembrolizumab
- description
- Participants received 300mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- OG006
- title
- Cohort B - 300mg QD LY3475070 + Pembrolizumab
- description
- Participants received 300mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study
- id
- OG007
- title
- Cohort B - 300mg BID LY3475070 + Pembrolizumab
- param Type
- GEOMETRIC_MEAN
- population Description
- All enrolled participants in phase1a who received LY3475070 and had intensively sampled evaluable PK data on cycle 1 day 1.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose)
- title
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Eight Hours (AUC[0-8]) of LY3475070
- type
- SECONDARY
- unit Of Measure
- nanograms*hours per milliliter (ng*h/mL)
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Preserved source evidence · Not medical advice