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NCT04148937 · FLOW

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A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer · Source last updated 2024-04-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        11
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        17
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        11
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        17
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        0
      8. 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
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        1
      8. 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
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        11
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        17
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        11
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        17
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        0
      8. 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
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        1
      8. 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