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NCT03206177 · FLOW

Participant flow

Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary · Source last updated 2024-08-07

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

groups
  1. description
    Patients will receive the following in every cycle (1 cycle=28days). * Paclitaxel - 175 mg/m2 over 3 hours via IV on Day 1 * Carboplatin - AUC 6\* (or AUC 5\*) over 1 hour via IV on Day 1 * Galunisertib - 150mg orally twice a day on Days 4-17
    id
    FG000
    title
    Paclitaxel/Carboplatin + Galunisertib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 26 enrolled participants, 24 met inclusion criteria (2 participants were screen-fails) and were assigned to the study arm to receive treatment. Of the 24 participants that received treatment, 23 participants were evaluable based on the protocol.
recruitment Details
This single site study conducted at the University of Oklahoma Stephenson Cancer Center enrolled 26 participants between August 2017 and March 2021. The first participant was enrolled on August 23, 2017 and the last participant was enrolled on March 29, 2021.
Complete source fields
groups
  1. description
    Patients will receive the following in every cycle (1 cycle=28days). * Paclitaxel - 175 mg/m2 over 3 hours via IV on Day 1 * Carboplatin - AUC 6\* (or AUC 5\*) over 1 hour via IV on Day 1 * Galunisertib - 150mg orally twice a day on Days 4-17
    id
    FG000
    title
    Paclitaxel/Carboplatin + Galunisertib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 26 enrolled participants, 24 met inclusion criteria (2 participants were screen-fails) and were assigned to the study arm to receive treatment. Of the 24 participants that received treatment, 23 participants were evaluable based on the protocol.
recruitment Details
This single site study conducted at the University of Oklahoma Stephenson Cancer Center enrolled 26 participants between August 2017 and March 2021. The first participant was enrolled on August 23, 2017 and the last participant was enrolled on March 29, 2021.

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Preserved source evidence · Not medical advice