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NCT01271712 · FLOW

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Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST) · Source last updated 2021-01-29

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

groups
  1. description
    Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    FG000
    title
    Regorafenib (Stivarga, BAY73-4506)
  2. description
    Double blind phase: participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Open Label phase: participants on placebo who switched to Regorafenib, received Regorafenib 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.
    id
    FG001
    title
    Placebo First, Then Option of Open Label Regorafenib Treatment
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        4
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        3
      type
      Progressive disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Non compliance with study drug
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      receive no study drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        66
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        132
      2. group Id
        FG001
        num Subjects
        66
      type
      Participants Received Treatment
    3. achievements
      1. comment
        91 participants started open-label treatment with regorafenib
        group Id
        FG000
        num Subjects
        91
      2. comment
        58 participants started open-label treatment with regorafenib
        group Id
        FG001
        num Subjects
        58
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Double Blind Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        8
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        32
      type
      Progressive disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      transferred to rollover study
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Non-compliance with study drug
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    9. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Switching to other therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        91
      2. group Id
        FG001
        num Subjects
        58
      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
        91
      2. group Id
        FG001
        num Subjects
        58
      type
      NOT COMPLETED
    title
    Open Label Treatment
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        7
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      Not analyzed after cutoff 08Jun2015
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      No follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Progressive disease
    milestones
    1. achievements
      1. comment
        All participants who discontinued study drug entered 30-day Safety Follow-up
        group Id
        FG000
        num Subjects
        118
      2. comment
        All participants who discontinued study drug entered 30-day Safety Follow-up
        group Id
        FG001
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        97
      2. group Id
        FG001
        num Subjects
        37
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        15
      type
      NOT COMPLETED
    title
    Safety Follow-up
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        6
      type
      Not analyzed after cutoff 08Jun2015
    milestones
    1. achievements
      1. comment
        All participants entered Survival Follow-up immediately after safety follow-up
        group Id
        FG000
        num Subjects
        100
      2. comment
        All participants entered Survival Follow-up immediately after safety follow-up
        group Id
        FG001
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. comment
        85 participants died and completed survival follow-up.
        group Id
        FG000
        num Subjects
        85
      2. comment
        33 participants died and completed survival follow-up.
        group Id
        FG001
        num Subjects
        33
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Survival Follow-up
pre Assignment Details
Participants were randomized in a 2:1 ratio to receive either regorafenib (133 patients) or placebo (66 patients). Randomization was stratified according 3rd vs. 4th line of therapy (at least 50% of patients were to be 3rd line), and geographical region (Asia vs.rest of world).
recruitment Details
A total of 240 participants with metastatic and/or unresectable GIST whose disease had progressed despite prior treatments with at least imatinib and sunitinib were screened; 199 were randomized. Patients must have shown objective disease progression or intolerance to imatinib, as well as disease progression while on sunitinib treatment.
Complete source fields
groups
  1. description
    Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    FG000
    title
    Regorafenib (Stivarga, BAY73-4506)
  2. description
    Double blind phase: participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Open Label phase: participants on placebo who switched to Regorafenib, received Regorafenib 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.
    id
    FG001
    title
    Placebo First, Then Option of Open Label Regorafenib Treatment
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        4
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        3
      type
      Progressive disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Non compliance with study drug
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      receive no study drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        66
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        132
      2. group Id
        FG001
        num Subjects
        66
      type
      Participants Received Treatment
    3. achievements
      1. comment
        91 participants started open-label treatment with regorafenib
        group Id
        FG000
        num Subjects
        91
      2. comment
        58 participants started open-label treatment with regorafenib
        group Id
        FG001
        num Subjects
        58
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Double Blind Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        8
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        32
      type
      Progressive disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      transferred to rollover study
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Non-compliance with study drug
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    9. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Switching to other therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        91
      2. group Id
        FG001
        num Subjects
        58
      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
        91
      2. group Id
        FG001
        num Subjects
        58
      type
      NOT COMPLETED
    title
    Open Label Treatment
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        7
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      Not analyzed after cutoff 08Jun2015
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      No follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Progressive disease
    milestones
    1. achievements
      1. comment
        All participants who discontinued study drug entered 30-day Safety Follow-up
        group Id
        FG000
        num Subjects
        118
      2. comment
        All participants who discontinued study drug entered 30-day Safety Follow-up
        group Id
        FG001
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        97
      2. group Id
        FG001
        num Subjects
        37
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        15
      type
      NOT COMPLETED
    title
    Safety Follow-up
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        6
      type
      Not analyzed after cutoff 08Jun2015
    milestones
    1. achievements
      1. comment
        All participants entered Survival Follow-up immediately after safety follow-up
        group Id
        FG000
        num Subjects
        100
      2. comment
        All participants entered Survival Follow-up immediately after safety follow-up
        group Id
        FG001
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. comment
        85 participants died and completed survival follow-up.
        group Id
        FG000
        num Subjects
        85
      2. comment
        33 participants died and completed survival follow-up.
        group Id
        FG001
        num Subjects
        33
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Survival Follow-up
pre Assignment Details
Participants were randomized in a 2:1 ratio to receive either regorafenib (133 patients) or placebo (66 patients). Randomization was stratified according 3rd vs. 4th line of therapy (at least 50% of patients were to be 3rd line), and geographical region (Asia vs.rest of world).
recruitment Details
A total of 240 participants with metastatic and/or unresectable GIST whose disease had progressed despite prior treatments with at least imatinib and sunitinib were screened; 199 were randomized. Patients must have shown objective disease progression or intolerance to imatinib, as well as disease progression while on sunitinib treatment.

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