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NCT02451943 · FLOW

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A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma · Source last updated 2025-07-15

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

groups
  1. description
    75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle up to 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle thereafter until documented progressive disease (PD) or discontinuation for any other reason.
    id
    FG000
    title
    Doxorubicin + Olaratumab
  2. description
    75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle up to 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle thereafter until PD or discontinuation for any other reason.
    id
    FG001
    title
    Doxorubicin + Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        16
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        258
      2. group Id
        FG001
        num Subjects
        251
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        257
      2. group Id
        FG001
        num Subjects
        249
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        242
      2. group Id
        FG001
        num Subjects
        227
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Completers include participants who died in the study.
Complete source fields
groups
  1. description
    75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle up to 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle thereafter until documented progressive disease (PD) or discontinuation for any other reason.
    id
    FG000
    title
    Doxorubicin + Olaratumab
  2. description
    75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle up to 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle thereafter until PD or discontinuation for any other reason.
    id
    FG001
    title
    Doxorubicin + Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        16
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        258
      2. group Id
        FG001
        num Subjects
        251
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        257
      2. group Id
        FG001
        num Subjects
        249
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        242
      2. group Id
        FG001
        num Subjects
        227
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Completers include participants who died in the study.

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Preserved source evidence · Not medical advice