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NCT04165031 · FLOW

Participant flow

A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation · Source last updated 2021-11-24

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

groups
  1. description
    Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.
    id
    FG000
    title
    LY3499446 Phase 1 Cohort A1 (High Dose)
  2. description
    Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.
    id
    FG001
    title
    LY3499446 Phase 1 Cohort AO (Mid Dose)
  3. description
    Participants received low dose LY 3499446 as oral monotherapy once daily (QD) in 21-day cycles.
    id
    FG002
    title
    LY3499446 Phase 1 Cohort A-2 (Low Dose)
  4. description
    LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). The trial was terminated prior to initiation of this portion.
    id
    FG003
    title
    LY3499446 + Combination Drug Phase 1
  5. description
    LY3499446 monotherapy orally. LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). The trial was terminated prior to initiation of this portion.
    id
    FG004
    title
    LY3499446 Monotherapy + Combination Drug Phase 2
  6. description
    Docetaxel IV infusion. The trial was terminated prior to initiation of this portion.
    id
    FG005
    title
    Docetaxel Phase 2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Adverse Event
    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
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      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
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      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
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A participant was identified as having completed the study if the participant was observed until event of progressive disease (PD) or death, or the participant had discontinued study treatment and is in follow up at the time of the final analysis. The study was terminated due to an unexpected toxicity finding.
Complete source fields
groups
  1. description
    Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.
    id
    FG000
    title
    LY3499446 Phase 1 Cohort A1 (High Dose)
  2. description
    Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.
    id
    FG001
    title
    LY3499446 Phase 1 Cohort AO (Mid Dose)
  3. description
    Participants received low dose LY 3499446 as oral monotherapy once daily (QD) in 21-day cycles.
    id
    FG002
    title
    LY3499446 Phase 1 Cohort A-2 (Low Dose)
  4. description
    LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). The trial was terminated prior to initiation of this portion.
    id
    FG003
    title
    LY3499446 + Combination Drug Phase 1
  5. description
    LY3499446 monotherapy orally. LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). The trial was terminated prior to initiation of this portion.
    id
    FG004
    title
    LY3499446 Monotherapy + Combination Drug Phase 2
  6. description
    Docetaxel IV infusion. The trial was terminated prior to initiation of this portion.
    id
    FG005
    title
    Docetaxel Phase 2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Adverse Event
    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
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      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
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      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
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A participant was identified as having completed the study if the participant was observed until event of progressive disease (PD) or death, or the participant had discontinued study treatment and is in follow up at the time of the final analysis. The study was terminated due to an unexpected toxicity finding.

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Preserved source evidence · Not medical advice