NCT04148937 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants received 150 milligrams (mg) LY3475070 orally once daily (QD) on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- FG000
- 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
- FG001
- title
- Cohort A - 300mg QD LY3475070
- description
- Participants received 300mg LY3475070 orally twice daily (BID) on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- FG002
- 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
- FG003
- 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
- FG004
- 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
- FG005
- 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
- FG006
- 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
- FG007
- title
- Cohort B - 300mg BID LY3475070 + Pembrolizumab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- type
- Lost to Follow-up
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 6
- group Id
- FG003
- num Subjects
- 4
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 11
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 17
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 6
- group Id
- FG003
- num Subjects
- 4
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 11
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 17
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 8
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 17
- comment
- Completers include participants who were observed until event (progressive disease or death) or had discontinued study treatment and was in follow up at the time of the final analysis.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 3
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- The study was initially designed to be conducted in two phases: Phase 1a (dose escalation cohorts A, B) and Phase 1b (dose expansion cohorts C1, C2, D1, D2, E). Based on Sponsor decision, Phase 1b expansion cohorts were not initiated, no participants were enrolled.
Complete source fields
- groups
- description
- Participants received 150 milligrams (mg) LY3475070 orally once daily (QD) on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- FG000
- 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
- FG001
- title
- Cohort A - 300mg QD LY3475070
- description
- Participants received 300mg LY3475070 orally twice daily (BID) on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
- id
- FG002
- 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
- FG003
- 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
- FG004
- 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
- FG005
- 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
- FG006
- 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
- FG007
- title
- Cohort B - 300mg BID LY3475070 + Pembrolizumab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- type
- Lost to Follow-up
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 6
- group Id
- FG003
- num Subjects
- 4
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 11
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 17
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 6
- group Id
- FG003
- num Subjects
- 4
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 11
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 17
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 8
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 17
- comment
- Completers include participants who were observed until event (progressive disease or death) or had discontinued study treatment and was in follow up at the time of the final analysis.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 3
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- The study was initially designed to be conducted in two phases: Phase 1a (dose escalation cohorts A, B) and Phase 1b (dose expansion cohorts C1, C2, D1, D2, E). Based on Sponsor decision, Phase 1b expansion cohorts were not initiated, no participants were enrolled.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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