TriangleNCT03601897 · OUTCOME
Number of Participants With Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to 2.89 years
What was measured
Number of participants (pts) who experienced serious adverse events (SAE) and adverse events (AE).
Analysis population: All participants who received any study drug.
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 | 24 |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 19 |
| Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 12 |
| 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 | 15 |
| Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 5 |
| Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 28 |
| Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 10 |
| Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 22 |
| Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 16 |
| Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 20 |
Reported measurements
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 16 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 12 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 9 | Not reported | Not reported | Not reported | Not reported |
Any AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 24 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 18 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 12 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 15 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 28 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 22 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 16 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 20 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 10
- group Id
- OG009
- value
- 9
- group Id
- OG010
- value
- 9
- title
- Any SAE
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 28
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 22
- group Id
- OG009
- value
- 16
- group Id
- OG010
- value
- 20
- title
- Any AE
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 28
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 22
- group Id
- OG009
- value
- 16
- group Id
- OG010
- value
- 20
- units
- Participants
- description
- Number of participants (pts) who experienced serious adverse events (SAE) and adverse events (AE).
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received any study drug.
- reporting Status
- POSTED
- time Frame
- Baseline up to 2.89 years
- title
- Number of Participants With Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice