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NCT02048371 · FLOW

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SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes · Source last updated 2023-11-07

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

groups
  1. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG000
    title
    Cohort A: Liposarcoma
  2. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    FG001
    title
    Cohort A: Liposarcoma, Placebo
  3. description
    Those patients who started on placebo and crossed over to active drug. Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG002
    title
    Cohort A: Liposarcoma Crossover
  4. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG003
    title
    Cohort B: Osteosarcoma
  5. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    FG004
    title
    Cohort B: Osteosarcoma, Placebo
  6. description
    Patients who started on placebo and crossed over to active drug. Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG005
    title
    Cohort B: Osteosarcoma Crossover
  7. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG006
    title
    Cohort C: Ewing Sarcoma
  8. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG007
    title
    Cohort D: Rhabdomyosarcoma
  9. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG008
    title
    Cohort E: Mesenchymal Chondrosarcoma
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        11
      7. group Id
        FG006
        num Subjects
        30
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        1
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        22
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Study enrollment ended early due to slow enrollment.
Complete source fields
groups
  1. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG000
    title
    Cohort A: Liposarcoma
  2. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    FG001
    title
    Cohort A: Liposarcoma, Placebo
  3. description
    Those patients who started on placebo and crossed over to active drug. Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG002
    title
    Cohort A: Liposarcoma Crossover
  4. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG003
    title
    Cohort B: Osteosarcoma
  5. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    FG004
    title
    Cohort B: Osteosarcoma, Placebo
  6. description
    Patients who started on placebo and crossed over to active drug. Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG005
    title
    Cohort B: Osteosarcoma Crossover
  7. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG006
    title
    Cohort C: Ewing Sarcoma
  8. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG007
    title
    Cohort D: Rhabdomyosarcoma
  9. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    FG008
    title
    Cohort E: Mesenchymal Chondrosarcoma
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        11
      7. group Id
        FG006
        num Subjects
        30
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        1
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        22
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Study enrollment ended early due to slow enrollment.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice