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NCT02371369 · FLOW

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Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) · Source last updated 2022-05-11

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

groups
  1. description
    Participants received Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration.
    id
    FG000
    title
    Pexidartinib Part 1, Then Pexidartinib Part 2
  2. description
    Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose. Placebo: Placebo capsule matching Pexidartinib capsule for oral administration. Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration (Part 2).
    id
    FG001
    title
    Placebo Part 1, Then Pexidartinib Part 2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        59
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        48
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Part 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        6
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Investigator decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Subject Noncompliance
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    8. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      type
      Subject transitioned to commercial supply
    9. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        9
      type
      Subject transitioned to another DS pexidartinib protocol
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Surgical resection of tumor
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. comment
        N=48; Only participants who were eligible to receive treatment in Part 2.
        group Id
        FG000
        num Subjects
        48
      2. comment
        N=30; Only participants who were eligible to receive treatment in Part 2.
        group Id
        FG001
        num Subjects
        30
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        30
      type
      NOT COMPLETED
    title
    Part 2
pre Assignment Details
Participants were screened for inclusion and exclusion criteria. Screening procedures were performed after consent was obtained and within the 42 days before the first dose of study drug, unless otherwise noted.
recruitment Details
Part 1 was a double-blind, randomized, Pexidartinib or placebo in participants with symptomatic TGCT for whom surgical resection would be associated with potentially worsening functional limitation or severe morbidity. Part 2 is a long-term treatment phase in which all eligible participants received open-label Pexidartinib.
Complete source fields
groups
  1. description
    Participants received Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration.
    id
    FG000
    title
    Pexidartinib Part 1, Then Pexidartinib Part 2
  2. description
    Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose. Placebo: Placebo capsule matching Pexidartinib capsule for oral administration. Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration (Part 2).
    id
    FG001
    title
    Placebo Part 1, Then Pexidartinib Part 2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        59
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        48
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Part 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        6
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Investigator decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Subject Noncompliance
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    8. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      type
      Subject transitioned to commercial supply
    9. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        9
      type
      Subject transitioned to another DS pexidartinib protocol
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Surgical resection of tumor
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. comment
        N=48; Only participants who were eligible to receive treatment in Part 2.
        group Id
        FG000
        num Subjects
        48
      2. comment
        N=30; Only participants who were eligible to receive treatment in Part 2.
        group Id
        FG001
        num Subjects
        30
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        30
      type
      NOT COMPLETED
    title
    Part 2
pre Assignment Details
Participants were screened for inclusion and exclusion criteria. Screening procedures were performed after consent was obtained and within the 42 days before the first dose of study drug, unless otherwise noted.
recruitment Details
Part 1 was a double-blind, randomized, Pexidartinib or placebo in participants with symptomatic TGCT for whom surgical resection would be associated with potentially worsening functional limitation or severe morbidity. Part 2 is a long-term treatment phase in which all eligible participants received open-label Pexidartinib.

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Preserved source evidence · Not medical advice