TriangleNCT03601897 · OUTCOME
Objective Response Rate (ORR) (Part 1 Escalation)
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 0.92 years)
What was measured
Percentage of pts who achieved an objective response of Complete Response (CR) or Partial Response (PR). 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. Modified RECIST (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 les
Analysis population: Part 1 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.
| 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 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 16.7 | Not reported | 4.7 | 37.7 | Not reported |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 21.4 | Not reported | 6.1 | 46.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.7
- upper Limit
- 37.7
- value
- 16.7
- group Id
- OG001
- lower Limit
- 6.1
- upper Limit
- 46.6
- value
- 21.4
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Percentage of pts who achieved an objective response of Complete Response (CR) or Partial Response (PR). 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. Modified RECIST (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 les
- 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
- param Type
- NUMBER
- population Description
- Part 1 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 0.92 years)
- title
- Objective Response Rate (ORR) (Part 1 Escalation)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice