TriangleNCT03601897 · OUTCOME
Progression-free-survival (PFS)
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 or Death due to Any Cause (Up to 2.61 years)
What was measured
Time from first dose of study drug to the earliest documented evidence of PD or death due to any cause. Participants who undergo surgical resection of target or non-target lesions, who have received other anticancer treatments, including surgical resection or radiation (other than palliative radiation to pre-existing bone metastases'), or who do not have a documented date of progression or death due to any cause will be censored at the date of the last assessment. PD per RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
Analysis population: mITT participants that 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 triple-negative breast cancer (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 triple-negative breast cancer (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 | 18 |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 14 |
| Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 10 |
| Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 6 |
| Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 13 |
| Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 4 |
| Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 26 |
| Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 9 |
| Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 20 |
| Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 14 |
| Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 6.5 | Not reported | 3.7 | 14.7 | Not reported |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | NA | Not reported | 1.7 | NA | PFS median and 90% CI were not estimable due to insufficient number of events. |
| Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 6.4 | Not reported | 1.8 | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 5.3 | Not reported | 1.3 | 8.7 | Not reported |
| Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 3.7 | Not reported | 1.9 | 6.4 | Not reported |
| Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | NA | Not reported | 1.8 | NA | PFS 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 | 9.1 | Not reported | 7.2 | 17.3 | Not reported |
| Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 7.7 | Not reported | 3.6 | 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 | 6.2 | Not reported | 1.8 | NA | The 90% CI was not estimable due to insufficient number of events. |
| Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 9.4 | Not reported | 5.5 | 12.0 | Not reported |
| Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 3.5 | Not reported | 1.8 | 3.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.7
- upper Limit
- 14.7
- value
- 6.5
- comment
- PFS median and 90% CI were not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 1.7
- upper Limit
- NA
- value
- NA
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG002
- lower Limit
- 1.8
- upper Limit
- NA
- value
- 6.4
- group Id
- OG003
- lower Limit
- 1.3
- upper Limit
- 8.7
- value
- 5.3
- group Id
- OG004
- lower Limit
- 1.9
- upper Limit
- 6.4
- value
- 3.7
- comment
- PFS median and 90% CI were not estimable due to insufficient number of events.
- group Id
- OG005
- lower Limit
- 1.8
- upper Limit
- NA
- value
- NA
- group Id
- OG006
- lower Limit
- 7.2
- upper Limit
- 17.3
- value
- 9.1
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG007
- lower Limit
- 3.6
- upper Limit
- NA
- value
- 7.7
- comment
- The 90% CI was not estimable due to insufficient number of events.
- group Id
- OG008
- lower Limit
- 1.8
- upper Limit
- NA
- value
- 6.2
- group Id
- OG009
- lower Limit
- 5.5
- upper Limit
- 12.0
- value
- 9.4
- group Id
- OG010
- lower Limit
- 1.8
- upper Limit
- 3.8
- value
- 3.5
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 26
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 20
- group Id
- OG009
- value
- 14
- group Id
- OG010
- value
- 19
- units
- Participants
- description
- Time from first dose of study drug to the earliest documented evidence of PD or death due to any cause. Participants who undergo surgical resection of target or non-target lesions, who have received other anticancer treatments, including surgical resection or radiation (other than palliative radiation to pre-existing bone metastases'), or who do not have a documented date of progression or death due to any cause will be censored at the date of the last assessment. PD per RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines 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 triple-negative breast cancer (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 triple-negative breast cancer (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 were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- First Dose of Study Drug to PD or Death due to Any Cause (Up to 2.61 years)
- title
- Progression-free-survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice