TriangleNCT04148937 · OUTCOME
PK: Maximum Concentration (Cmax) 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/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 of Cycles 1 and 2 (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: Cmax of LY3475070
Analysis population: All enrolled participants in phase1a who received LY3475070 and had intensively sampled evaluable PK data on cycle 1 day 1, cycle 2 day 1 for this outcome. 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 | 5 |
| Cohort A - 600mg QD LY3475070 | 4 |
| Cohort B - 150mg QD LY3475070 + Pembrolizumab | 3 |
| Cohort B - 150mg BID LY3475070 + Pembrolizumab | 8 |
| Cohort B - 300mg QD LY3475070 + Pembrolizumab | 1 |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 15 |
Reported measurements
Cycle 1 Day 1
| 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 | 8 |
| Cohort B - 300mg QD LY3475070 + Pembrolizumab | 1 |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 14 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A - 150mg QD LY3475070 | 1750 | 13.2 | Not reported | Not reported | Not reported |
| Cohort A - 300mg QD LY3475070 | 2060 | 61.3 | Not reported | Not reported | Not reported |
| Cohort A - 300mg BID LY3475070 | 2960 | 113 | Not reported | Not reported | Not reported |
| Cohort A - 600mg QD LY3475070 | 4320 | 29.2 | Not reported | Not reported | Not reported |
| Cohort B - 150mg QD LY3475070 + Pembrolizumab | 1100 | 63.1 | Not reported | Not reported | Not reported |
| Cohort B - 150mg BID LY3475070 + Pembrolizumab | 974 | 107 | 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: 3270 ng/mL |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 2670 | 39.6 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| 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 | 8 |
| Cohort B - 300mg QD LY3475070 + Pembrolizumab | 0 |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A - 150mg QD LY3475070 | 1770 | 32.9 | Not reported | Not reported | Not reported |
| Cohort A - 300mg QD LY3475070 | 2310 | 105 | Not reported | Not reported | Not reported |
| Cohort A - 300mg BID LY3475070 | 4270 | 87.5 | Not reported | Not reported | Not reported |
| Cohort A - 600mg QD LY3475070 | 4610 | 17.2 | Not reported | Not reported | Not reported |
| Cohort B - 150mg QD LY3475070 + Pembrolizumab | 1340 | 72.2 | Not reported | Not reported | Not reported |
| Cohort B - 150mg BID LY3475070 + Pembrolizumab | 1060 | 170 | Not reported | Not reported | Not reported |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 3200 | 58.2 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.2
- value
- 1750
- group Id
- OG001
- spread
- 61.3
- value
- 2060
- group Id
- OG002
- spread
- 113
- value
- 2960
- group Id
- OG003
- spread
- 29.2
- value
- 4320
- group Id
- OG004
- spread
- 63.1
- value
- 1100
- group Id
- OG005
- spread
- 107
- value
- 974
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 3270 ng/mL
- group Id
- OG006
- spread
- NA
- value
- NA
- group Id
- OG007
- spread
- 39.6
- value
- 2670
- 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
- 8
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 14
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 32.9
- value
- 1770
- group Id
- OG001
- spread
- 105
- value
- 2310
- group Id
- OG002
- spread
- 87.5
- value
- 4270
- group Id
- OG003
- spread
- 17.2
- value
- 4610
- group Id
- OG004
- spread
- 72.2
- value
- 1340
- group Id
- OG005
- spread
- 170
- value
- 1060
- group Id
- OG007
- spread
- 58.2
- value
- 3200
- 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
- 8
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 15
- units
- Participants
- title
- Cycle 2 Day 1
- 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
- 8
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 15
- units
- Participants
- description
- PK: Cmax 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, cycle 2 day 1 for this outcome. 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
- Day 1 of Cycles 1 and 2 (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: Maximum Concentration (Cmax) of LY3475070
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice