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NCT01849874 · FLOW

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A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer · Source last updated 2023-10-30

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

groups
  1. description
    Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
    id
    FG000
    title
    MEK162
  2. description
    Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
    id
    FG001
    title
    Physician's Choice
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        89
      2. group Id
        FG001
        num Subjects
        42
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        16
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        93
      2. group Id
        FG001
        num Subjects
        48
      type
      Study Termination By Sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Completed as per protocol amendment 6
    6. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        4
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        228
      2. group Id
        FG001
        num Subjects
        113
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        227
      2. group Id
        FG001
        num Subjects
        106
      type
      Treated
    3. achievements
      1. comment
        The safety population number reported as "At risk" in AE section.
        group Id
        FG000
        num Subjects
        227
      2. comment
        The safety population number reported as "At risk" in AE section.
        group Id
        FG001
        num Subjects
        106
      comment
      Safety population consisted of all participants who received at any dose of study intervention (MEK162 or physician's choice chemotherapy).
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        No data, safety or efficacy, were collected for crossover set, as the crossover period was stopped early.
        group Id
        FG001
        num Subjects
        18
      comment
      After failure of physician's choice chemotherapy in the randomized period, participants entered into the crossover period to receive MEK162 treatment 45 mg orally twice daily with water irrespective of food, continuously, starting on Day 1 of the crossover period. Crossover from physician's choice chemotherapy treatment to MEK162 treatment was no longer permitted after enrollment was early discontinued.
      type
      Crossover Period
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        228
      2. group Id
        FG001
        num Subjects
        113
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
As of the data cutoff date of 20 Jan 2016 for primary completion date (PCD), a total of 303 participants were enrolled, with 201 (200 treated) in MEK162 group and 102 (94 treated) in physician's choice group. After PCD, additional 27 participants were enrolled in MEK162 group and 11 in physician's choice group. Data reported was based on the last participant last visit date (23 Aug 2022). Note: one participant was enrolled before PCD and received the first dose after PCD.
Complete source fields
groups
  1. description
    Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
    id
    FG000
    title
    MEK162
  2. description
    Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
    id
    FG001
    title
    Physician's Choice
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        89
      2. group Id
        FG001
        num Subjects
        42
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        16
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        93
      2. group Id
        FG001
        num Subjects
        48
      type
      Study Termination By Sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Completed as per protocol amendment 6
    6. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        4
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        228
      2. group Id
        FG001
        num Subjects
        113
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        227
      2. group Id
        FG001
        num Subjects
        106
      type
      Treated
    3. achievements
      1. comment
        The safety population number reported as "At risk" in AE section.
        group Id
        FG000
        num Subjects
        227
      2. comment
        The safety population number reported as "At risk" in AE section.
        group Id
        FG001
        num Subjects
        106
      comment
      Safety population consisted of all participants who received at any dose of study intervention (MEK162 or physician's choice chemotherapy).
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        No data, safety or efficacy, were collected for crossover set, as the crossover period was stopped early.
        group Id
        FG001
        num Subjects
        18
      comment
      After failure of physician's choice chemotherapy in the randomized period, participants entered into the crossover period to receive MEK162 treatment 45 mg orally twice daily with water irrespective of food, continuously, starting on Day 1 of the crossover period. Crossover from physician's choice chemotherapy treatment to MEK162 treatment was no longer permitted after enrollment was early discontinued.
      type
      Crossover Period
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        228
      2. group Id
        FG001
        num Subjects
        113
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
As of the data cutoff date of 20 Jan 2016 for primary completion date (PCD), a total of 303 participants were enrolled, with 201 (200 treated) in MEK162 group and 102 (94 treated) in physician's choice group. After PCD, additional 27 participants were enrolled in MEK162 group and 11 in physician's choice group. Data reported was based on the last participant last visit date (23 Aug 2022). Note: one participant was enrolled before PCD and received the first dose after PCD.

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Preserved source evidence · Not medical advice