TriangleNCT03601897 · OUTCOME
Objective Response Rate (ORR) (Part 2 Expansion)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Baseline to PD or Death due to Any Cause (Up to 1.54 years)
What was measured
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) 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.
Analysis population: Part 2 mITT participants that were evaluable for this outcome measure.
Groups in this outcome
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 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 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 0 | Not reported | 0.0 | 25.9 | Not reported |
| Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 16.7 | Not reported | 0.9 | 58.2 | Not reported |
| Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 7.7 | Not reported | 0.4 | 31.6 | Not reported |
| Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 25.0 | Not reported | 1.3 | 75.1 | Not reported |
| Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 30.8 | Not reported | 16.3 | 48.7 | Not reported |
| Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 11.1 | Not reported | 0.6 | 42.9 | Not reported |
| Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 20.0 | Not reported | 7.1 | 40.1 | Not reported |
| Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 35.7 | Not reported | 15.3 | 61.0 | Not reported |
| Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 5.3 | Not reported | 0.3 | 22.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 25.9
- value
- 0
- group Id
- OG001
- lower Limit
- 0.9
- upper Limit
- 58.2
- value
- 16.7
- group Id
- OG002
- lower Limit
- 0.4
- upper Limit
- 31.6
- value
- 7.7
- group Id
- OG003
- lower Limit
- 1.3
- upper Limit
- 75.1
- value
- 25.0
- group Id
- OG004
- lower Limit
- 16.3
- upper Limit
- 48.7
- value
- 30.8
- group Id
- OG005
- lower Limit
- 0.6
- upper Limit
- 42.9
- value
- 11.1
- group Id
- OG006
- lower Limit
- 7.1
- upper Limit
- 40.1
- value
- 20.0
- group Id
- OG007
- lower Limit
- 15.3
- upper Limit
- 61.0
- value
- 35.7
- group Id
- OG008
- lower Limit
- 0.3
- upper Limit
- 22.6
- value
- 5.3
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 26
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 20
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 19
- units
- Participants
- description
- Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) 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.
- dispersion Type
- 90% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- 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
- OG006
- 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
- OG007
- 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
- OG008
- title
- Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
- param Type
- NUMBER
- population Description
- Part 2 mITT participants that were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline to PD or Death due to Any Cause (Up to 1.54 years)
- title
- Objective Response Rate (ORR) (Part 2 Expansion)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice