TriangleNCT04148937 · OUTCOME
Progression-Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 10.4 Months)
What was measured
PFS is defined as the time from the date of start of treatment to the first date of the observed clinical or radiologically documented progressive disease or death due to any cause, whichever occurs first, was estimated and reported for all evaluable participants. For participants who were not known to have died or progressed as of the data-inclusion cut-off date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy.
Analysis population: All enrolled participants in phase1a who received at least one dose of LY3475070 (including censored). Number of participants censored: 150mg QD LY3475070=1, 300mg QD LY3475070=1, 300mg BID LY3475070=4, 600mg QD LY3475070=1, 150mg QD LY3475070 + pembrolizumab=2, 150mg BID LY3475070 + pembrolizumab=5, 300mg QD LY3475070 + pembrolizumab=1, 300mg BID LY3475070 + pembrolizumab=14.
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 | 6 |
| Cohort A - 600mg QD LY3475070 | 4 |
| Cohort B - 150mg QD LY3475070 + Pembrolizumab | 3 |
| Cohort B - 150mg BID LY3475070 + Pembrolizumab | 11 |
| Cohort B - 300mg QD LY3475070 + Pembrolizumab | 1 |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A - 150mg QD LY3475070 | 2.71 | Not reported | 0.03 | 3.42 | Not reported |
| Cohort A - 300mg QD LY3475070 | 1.91 | Not reported | 0.03 | 4.8 | Not reported |
| Cohort A - 300mg BID LY3475070 | 0.89 | Not reported | 0.03 | 2.14 | Not reported |
| Cohort A - 600mg QD LY3475070 | 1.33 | Not reported | 0.03 | 2.04 | Not reported |
| Cohort B - 150mg QD LY3475070 + Pembrolizumab | 2 | Not reported | 0.03 | 2.04 | Not reported |
| Cohort B - 150mg BID LY3475070 + Pembrolizumab | 0.53 | Not reported | 0.03 | 3.52 | Not reported |
| Cohort B - 300mg QD LY3475070 + Pembrolizumab | 0.03 | Not reported | 0.03 | 0.03 | Not reported |
| Cohort B - 300mg BID LY3475070 + Pembrolizumab | 0.03 | Not reported | 0.03 | 2.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- upper Limit
- 3.42
- value
- 2.71
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 4.8
- value
- 1.91
- group Id
- OG002
- lower Limit
- 0.03
- upper Limit
- 2.14
- value
- 0.89
- group Id
- OG003
- lower Limit
- 0.03
- upper Limit
- 2.04
- value
- 1.33
- group Id
- OG004
- lower Limit
- 0.03
- upper Limit
- 2.04
- value
- 2
- group Id
- OG005
- lower Limit
- 0.03
- upper Limit
- 3.52
- value
- 0.53
- group Id
- OG006
- lower Limit
- 0.03
- upper Limit
- 0.03
- value
- 0.03
- group Id
- OG007
- lower Limit
- 0.03
- upper Limit
- 2.5
- value
- 0.03
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 17
- units
- Participants
- description
- PFS is defined as the time from the date of start of treatment to the first date of the observed clinical or radiologically documented progressive disease or death due to any cause, whichever occurs first, was estimated and reported for all evaluable participants. For participants who were not known to have died or progressed as of the data-inclusion cut-off date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- All enrolled participants in phase1a who received at least one dose of LY3475070 (including censored). Number of participants censored: 150mg QD LY3475070=1, 300mg QD LY3475070=1, 300mg BID LY3475070=4, 600mg QD LY3475070=1, 150mg QD LY3475070 + pembrolizumab=2, 150mg BID LY3475070 + pembrolizumab=5, 300mg QD LY3475070 + pembrolizumab=1, 300mg BID LY3475070 + pembrolizumab=14.
- reporting Status
- POSTED
- time Frame
- Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 10.4 Months)
- title
- Progression-Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice