TriangleNCT03601897 · OUTCOME
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanograms/milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)
What was measured
Measure the Cmax
Analysis population: Part 1 participants who received any study drug and had evaluable Cmax data at each timepoint.
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 | 24 |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 19 |
Reported measurements
Cycle 1 Day 1
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 77.4 | 67.7 | Not reported | Not reported | Not reported |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 132 | 76.4 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 19 |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 | 89.7 | 80.1 | Not reported | Not reported | Not reported |
| Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 | 143 | 47.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 67.7
- value
- 77.4
- group Id
- OG001
- spread
- 76.4
- value
- 132
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 19
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 80.1
- value
- 89.7
- group Id
- OG001
- spread
- 47.6
- value
- 143
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 19
- units
- Participants
- description
- Measure the Cmax
- dispersion Type
- Geometric Coefficient of Variation
- 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
- GEOMETRIC_MEAN
- population Description
- Part 1 participants who received any study drug and had evaluable Cmax data at each timepoint.
- reporting Status
- POSTED
- time Frame
- Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)
- title
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
- type
- SECONDARY
- unit Of Measure
- nanograms/milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice