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NCT01969838 · FLOW

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Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis · Source last updated 2023-05-12

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

groups
  1. description
    Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
    id
    FG000
    title
    Momelotinib (MMB)
  2. description
    Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily (BID). The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
    id
    FG001
    title
    Ruxolitinib (RUX)
  3. description
    After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the MMB group at study entry continued MMB in the open-label treatment phase at their current dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
    id
    FG002
    title
    MMB to MMB
  4. description
    After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the RUX group who wished to remain in the study initiated MMB in the open-label treatment phase at the dose matching their equivalent MMB placebo dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
    id
    FG003
    title
    RUX to MMB
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Subject Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Symptomatic Spleen Growth
    milestones
    1. achievements
      1. comment
        The MMB group is only applicable to the double-blind phase. Participants who complete the double-blind phase and continue to receive MMB in the open-label phase constitute the MMB to MMB group.
        group Id
        FG000
        num Subjects
        215
      2. comment
        The RUX group is only applicable to the double-blind phase. Participants who complete the double-blind phase and begin receiving MMB in the open-label phase constitute the RUX to MMB group.
        group Id
        FG001
        num Subjects
        217
      3. comment
        The MMB to MMB group is only applicable to the open-label phase.
        group Id
        FG002
        num Subjects
        0
      4. comment
        The RUX to MMB group is only applicable to the open-label phase.
        group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        188
      2. group Id
        FG001
        num Subjects
        208
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-blind Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        52
      4. group Id
        FG003
        num Subjects
        62
      type
      Transferred to study SRA-MMB-4365
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        37
      4. group Id
        FG003
        num Subjects
        49
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        27
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        19
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        15
      type
      Subject Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        11
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        14
      type
      Physician Decision
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Non-compliance with Study Drug
    milestones
    1. achievements
      1. comment
        The MMB group is only applicable to the double-blind phase. Participants who complete the double-blind phase and continue to receive MMB in the open-label phase constitute the MMB to MMB group.
        group Id
        FG000
        num Subjects
        0
      2. comment
        The RUX group is only applicable to the double-blind phase. Participants who complete the double-blind phase and begin receiving MMB in the open-label phase constitute the RUX to MMB group.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Of 188 participants in the MMB group who completed the double-blind phase, 171 entered the open-label phase to continue receiving MMB.
        group Id
        FG002
        num Subjects
        171
      4. comment
        Of 208 participants in the RUX group who completed the double-blind phase, 197 entered the open-label phase to begin receiving MMB.
        group Id
        FG003
        num Subjects
        197
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        The Sponsor terminated the study prior to subjects completing the 5 years of follow-up with the exception of a single subject. Subjects receiving MMB at the time of study termination were eligible to transition to an extended access study (SRA-MMB-4365) to continue MMB treatment.
        group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      comment
      Defined as completing survival follow-up for a period of up to 5 years from randomization.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        170
      4. group Id
        FG003
        num Subjects
        197
      type
      NOT COMPLETED
    title
    Open-label Phase
pre Assignment Details
Participants were screened within 35 days after signing the informed consent form to determine eligibility for participation in the study. Participants who were not randomized within the 35 day screening window were screen failed. At randomization, participants were randomly assigned 1:1 to MMB plus RUX-placebo or RUX plus MMB-placebo.
recruitment Details
432 participants were randomized at 131 centers in 22 countries.
Complete source fields
groups
  1. description
    Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
    id
    FG000
    title
    Momelotinib (MMB)
  2. description
    Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily (BID). The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
    id
    FG001
    title
    Ruxolitinib (RUX)
  3. description
    After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the MMB group at study entry continued MMB in the open-label treatment phase at their current dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
    id
    FG002
    title
    MMB to MMB
  4. description
    After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the RUX group who wished to remain in the study initiated MMB in the open-label treatment phase at the dose matching their equivalent MMB placebo dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
    id
    FG003
    title
    RUX to MMB
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Subject Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Symptomatic Spleen Growth
    milestones
    1. achievements
      1. comment
        The MMB group is only applicable to the double-blind phase. Participants who complete the double-blind phase and continue to receive MMB in the open-label phase constitute the MMB to MMB group.
        group Id
        FG000
        num Subjects
        215
      2. comment
        The RUX group is only applicable to the double-blind phase. Participants who complete the double-blind phase and begin receiving MMB in the open-label phase constitute the RUX to MMB group.
        group Id
        FG001
        num Subjects
        217
      3. comment
        The MMB to MMB group is only applicable to the open-label phase.
        group Id
        FG002
        num Subjects
        0
      4. comment
        The RUX to MMB group is only applicable to the open-label phase.
        group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        188
      2. group Id
        FG001
        num Subjects
        208
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-blind Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        52
      4. group Id
        FG003
        num Subjects
        62
      type
      Transferred to study SRA-MMB-4365
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        37
      4. group Id
        FG003
        num Subjects
        49
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        27
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        19
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        15
      type
      Subject Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        11
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        14
      type
      Physician Decision
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Non-compliance with Study Drug
    milestones
    1. achievements
      1. comment
        The MMB group is only applicable to the double-blind phase. Participants who complete the double-blind phase and continue to receive MMB in the open-label phase constitute the MMB to MMB group.
        group Id
        FG000
        num Subjects
        0
      2. comment
        The RUX group is only applicable to the double-blind phase. Participants who complete the double-blind phase and begin receiving MMB in the open-label phase constitute the RUX to MMB group.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Of 188 participants in the MMB group who completed the double-blind phase, 171 entered the open-label phase to continue receiving MMB.
        group Id
        FG002
        num Subjects
        171
      4. comment
        Of 208 participants in the RUX group who completed the double-blind phase, 197 entered the open-label phase to begin receiving MMB.
        group Id
        FG003
        num Subjects
        197
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        The Sponsor terminated the study prior to subjects completing the 5 years of follow-up with the exception of a single subject. Subjects receiving MMB at the time of study termination were eligible to transition to an extended access study (SRA-MMB-4365) to continue MMB treatment.
        group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      comment
      Defined as completing survival follow-up for a period of up to 5 years from randomization.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        170
      4. group Id
        FG003
        num Subjects
        197
      type
      NOT COMPLETED
    title
    Open-label Phase
pre Assignment Details
Participants were screened within 35 days after signing the informed consent form to determine eligibility for participation in the study. Participants who were not randomized within the 35 day screening window were screen failed. At randomization, participants were randomly assigned 1:1 to MMB plus RUX-placebo or RUX plus MMB-placebo.
recruitment Details
432 participants were randomized at 131 centers in 22 countries.

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Preserved source evidence · Not medical advice