NCT03717415 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 14
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 18
- group Id
- FG006
- num Subjects
- 2
- group Id
- FG007
- num Subjects
- 6
- group Id
- FG008
- num Subjects
- 11
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 12
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 18
- group Id
- FG006
- num Subjects
- 2
- group Id
- FG007
- num Subjects
- 6
- 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
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 4
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 12
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 3
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 5
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 6
- group Id
- FG006
- num Subjects
- 2
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 8
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 14
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 18
- group Id
- FG006
- num Subjects
- 2
- group Id
- FG007
- num Subjects
- 6
- group Id
- FG008
- num Subjects
- 11
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 12
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 18
- group Id
- FG006
- num Subjects
- 2
- group Id
- FG007
- num Subjects
- 6
- 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
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 4
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 12
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 3
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 5
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 6
- group Id
- FG006
- num Subjects
- 2
- group Id
- FG007
- num Subjects
- 3
- 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
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