TriangleNCT04148937 · OUTCOME
PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCtau) of LY3475070
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*h/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 2 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose for the QD arms, Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose for the BID arms)
What was measured
PK: AUCtau of LY3475070
Analysis population: All enrolled participants in phase1a who received LY3475070 and had intensively sampled evaluable PK data on cycle 2 day 1. For "Cohort B - 300mg QD LY3475070 + pembrolizumab," the participant has not received the treatment on cycle 2 day 1, and did not meet the analysis criteria. Thus, zero participants were analysed.
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 | 3 |
| Cohort A - 600mg QD LY3475070 | 3 |
| Cohort B - 150mg QD LY3475070 + Pembrolizumab | 3 |
| Cohort B - 150mg BID LY3475070 + Pembrolizumab | 6 |
| Cohort B - 300mg QD LY3475070 + Pembrolizumab | 0 |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A - 150mg QD LY3475070 | 7950 | 73.6 | Not reported | Not reported | Not reported |
| Cohort A - 300mg QD LY3475070 | 8320 | 106 | Not reported | Not reported | Not reported |
| Cohort A - 300mg BID LY3475070 | 19600 | 117 | Not reported | Not reported | Not reported |
| Cohort A - 600mg QD LY3475070 | 26200 | 11.4 | Not reported | Not reported | Not reported |
| Cohort B - 150mg QD LY3475070 + Pembrolizumab | 3180 | 152 | Not reported | Not reported | Not reported |
| Cohort B - 150mg BID LY3475070 + Pembrolizumab | 3280 | 370 | Not reported | Not reported | Not reported |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 12400 | 80.2 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 73.6
- value
- 7950
- group Id
- OG001
- spread
- 106
- value
- 8320
- group Id
- OG002
- spread
- 117
- value
- 19600
- group Id
- OG003
- spread
- 11.4
- value
- 26200
- group Id
- OG004
- spread
- 152
- value
- 3180
- group Id
- OG005
- spread
- 370
- value
- 3280
- group Id
- OG007
- spread
- 80.2
- value
- 12400
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 12
- units
- Participants
- description
- PK: AUCtau 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 2 day 1. For "Cohort B - 300mg QD LY3475070 + pembrolizumab," the participant has not received the treatment on cycle 2 day 1, and did not meet the analysis criteria. Thus, zero participants were analysed.
- reporting Status
- POSTED
- time Frame
- Cycle 2 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose for the QD arms, Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose for the BID arms)
- title
- PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCtau) of LY3475070
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
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Preserved source evidence · Not medical advice