TriangleNCT03717415 · OUTCOME
Time to Progression (TTP)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- First Dose of Study Drug to PD (Up to 1.63 years)
What was measured
Time from first dose of study drug to the first documentation of progressive disease (PD). Participants were considered to have progressive disease if they had documented progression based on radiologic assessment according to RECIST v1.1. RECIST v1.1 defined disease progression as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions.
Analysis population: mITT participants that were evaluable for this outcome measure.
Groups in this outcome
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
Dose escalation with 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.
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
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.
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
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.
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in 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.
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
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.
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
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.
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
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.
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
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.
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
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.
| Group | Source count |
|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | 2 |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 6 |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 4 |
| Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 7 |
| Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 2 |
| Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 11 |
| Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 2 |
| Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 2 |
| Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | 1.4 | Not reported | 0.9 | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 4.0 | Not reported | 1.4 | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 2.3 | Not reported | 1.2 | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 1.5 | Not reported | 1.1 | 3.2 | Not reported |
| Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 1.3 | Not reported | 1.2 | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5 | 6.7 | Not reported | 4.6 | 13.3 | Not reported |
| Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 14.6 | Not reported | 9.8 | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5 | NA | Not reported | 4.5 | NA | TTP median and 90% CI were not estimable due to insufficient number of events. |
| Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5 | 4.9 | Not reported | 3.2 | NA | The 90% CI was not estimable due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- NA
- value
- 1.4
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 4.0
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG002
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 2.3
- group Id
- OG003
- lower Limit
- 1.1
- upper Limit
- 3.2
- value
- 1.5
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG004
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 1.3
- group Id
- OG005
- lower Limit
- 4.6
- upper Limit
- 13.3
- value
- 6.7
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG006
- lower Limit
- 9.8
- upper Limit
- NA
- value
- 14.6
- comment
- TTP median and 90% CI were not estimable due to insufficient number of events.
- group Id
- OG007
- lower Limit
- 4.5
- upper Limit
- NA
- value
- NA
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG008
- lower Limit
- 3.2
- upper Limit
- NA
- value
- 4.9
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 6
- units
- Participants
- description
- Time from first dose of study drug to the first documentation of progressive disease (PD). Participants were considered to have progressive disease if they had documented progression based on radiologic assessment according to RECIST v1.1. RECIST v1.1 defined disease progression as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Dose escalation with 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
- OG000
- 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
- OG001
- 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
- OG002
- title
- Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
- description
- Dose expansion in 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
- OG003
- 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
- OG004
- 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
- OG005
- 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
- OG006
- 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
- OG007
- 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
- OG008
- title
- Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
- param Type
- MEDIAN
- population Description
- mITT participants that were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- First Dose of Study Drug to PD (Up to 1.63 years)
- title
- Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice