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NCT03717415 · FLOW

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A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors · Source last updated 2024-12-27

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

groups
  1. description
    Dose escalation with rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in 21-day cycles in combination with carboplatin administered by intravenous (IV) infusion at area under the curve (AUC)5 at Day 1 of each 21-day cycle.
    id
    FG000
    title
    Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
  2. description
    Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG001
    title
    Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
  3. description
    Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
    id
    FG002
    title
    Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
  4. description
    Dose expansion in triple-negative breast cancer (TNBC) participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG003
    title
    Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
  5. description
    Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG004
    title
    Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
  6. description
    Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG005
    title
    Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
  7. description
    Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG006
    title
    Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
  8. description
    Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG007
    title
    Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
  9. description
    Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG008
    title
    Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        18
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        18
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        11
      comment
      Modified Intent-to-Treat (mITT) Population includes all participants who had at least one full dose of the combined study drugs, had measurable disease at baseline, and had at least one post-baseline assessment. Participants without a post-baseline assessment who discontinued study treatment due to clinical progression, death, or a rebastinib-related AE will also be included in the mITT population.
      type
      mITT Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        3
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Dose escalation with rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in 21-day cycles in combination with carboplatin administered by intravenous (IV) infusion at area under the curve (AUC)5 at Day 1 of each 21-day cycle.
    id
    FG000
    title
    Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
  2. description
    Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG001
    title
    Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
  3. description
    Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
    id
    FG002
    title
    Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
  4. description
    Dose expansion in triple-negative breast cancer (TNBC) participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG003
    title
    Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
  5. description
    Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG004
    title
    Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
  6. description
    Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG005
    title
    Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
  7. description
    Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG006
    title
    Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
  8. description
    Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG007
    title
    Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
  9. description
    Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    FG008
    title
    Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        18
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        18
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        11
      comment
      Modified Intent-to-Treat (mITT) Population includes all participants who had at least one full dose of the combined study drugs, had measurable disease at baseline, and had at least one post-baseline assessment. Participants without a post-baseline assessment who discontinued study treatment due to clinical progression, death, or a rebastinib-related AE will also be included in the mITT population.
      type
      mITT Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        3
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice