TriangleNCT03601897 · OUTCOME
Duration of Response (DOR)
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
- Time from CR or PR to PD or Death due to Any Cause (Up to 1.54 years)
What was measured
Time from CR or PR to the earliest documented evidence of PD or death due to any cause. Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to \<10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
Analysis population: mITT participants that had CR or PR and were evaluable for this outcome measure.
Groups in this outcome
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
| Group | Source count |
|---|---|
| Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 3 |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 3 |
| Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 0 |
| Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 1 |
| Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 1 |
| Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 1 |
| Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 8 |
| Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 1 |
| Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 4 |
| Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 5 |
| Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 11.1 | Not reported | NA | NA | The 90% Confidence Interval (CI) was not estimable due to insufficient number of events. |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | NA | Not reported | NA | NA | DOR median and 90% CI were not estimable due to insufficient number of events. |
| Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 6.9 | Not reported | NA | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 7.4 | Not reported | NA | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | NA | Not reported | NA | NA | DOR median and 90% CI were not estimable due to insufficient number of events. |
| Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 6.5 | Not reported | 5.4 | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 5.5 | Not reported | NA | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | NA | Not reported | 4.6 | NA | DOR median and 90% CI were not estimable due to insufficient number of events. |
| Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 8.8 | Not reported | 7.4 | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | NA | Not reported | NA | NA | DOR median and 90% CI were not estimable due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- The 90% Confidence Interval (CI) was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 11.1
- comment
- DOR median and 90% CI were not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.9
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- 7.4
- comment
- DOR median and 90% CI were not estimable due to insufficient number of events.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG006
- lower Limit
- 5.4
- upper Limit
- NA
- value
- 6.5
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG007
- lower Limit
- NA
- upper Limit
- NA
- value
- 5.5
- comment
- DOR median and 90% CI were not estimable due to insufficient number of events.
- group Id
- OG008
- lower Limit
- 4.6
- upper Limit
- NA
- value
- NA
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG009
- lower Limit
- 7.4
- upper Limit
- NA
- value
- 8.8
- comment
- DOR median and 90% CI were not estimable due to insufficient number of events.
- group Id
- OG010
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 1
- units
- Participants
- description
- Time from CR or PR to the earliest documented evidence of PD or death due to any cause. Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to \<10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG000
- title
- Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
- description
- Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG001
- title
- Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
- description
- Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG002
- title
- Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
- description
- Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG003
- title
- Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
- description
- Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG004
- title
- Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
- description
- Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG005
- title
- Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
- description
- Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG006
- title
- Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
- description
- Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG007
- title
- Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
- description
- Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG008
- title
- Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
- description
- Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG009
- title
- Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
- description
- Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
- id
- OG010
- title
- Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
- param Type
- MEDIAN
- population Description
- mITT participants that had CR or PR and were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Time from CR or PR to PD or Death due to Any Cause (Up to 1.54 years)
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice