TriangleNCT01962103 · OUTCOME
Phase 1: Volume of Distribution (Vss)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- liters
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)
Analysis population: PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.
Groups in this outcome
Phase 1: Nab-Paclitaxel 120 mg/m^2
nab-paclitaxel 120 mg/m\^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).
Phase 1: Nab-Paclitaxel 150 mg/m^2
nab-paclitaxel 150 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
Phase 1: Nab-Paclitaxel 180 mg/m^2
nab-paclitaxel 180 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
Phase 1: Nab-Paclitaxel 210 mg/m^2
nab-paclitaxel 210 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
Phase 1: Nab-Paclitaxel 240 mg/m^2
nab-paclitaxel 240 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
Phase 1: Nab-Paclitaxel 270 mg/m^2
nab-paclitaxel 270 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
| Group | Source count |
|---|---|
| Phase 1: Nab-Paclitaxel 120 mg/m^2 | 9 |
| Phase 1: Nab-Paclitaxel 150 mg/m^2 | 6 |
| Phase 1: Nab-Paclitaxel 180 mg/m^2 | 10 |
| Phase 1: Nab-Paclitaxel 210 mg/m^2 | 6 |
| Phase 1: Nab-Paclitaxel 240 mg/m^2 | 6 |
| Phase 1: Nab-Paclitaxel 270 mg/m^2 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Nab-Paclitaxel 120 mg/m^2 | 127 | 145 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 150 mg/m^2 | 266 | 78.3 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 180 mg/m^2 | 146 | 106 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 210 mg/m^2 | 89.8 | 45.1 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 240 mg/m^2 | 175 | 117 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 270 mg/m^2 | 446 | 17.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 145
- value
- 127
- group Id
- OG001
- spread
- 78.3
- value
- 266
- group Id
- OG002
- spread
- 106
- value
- 146
- group Id
- OG003
- spread
- 45.1
- value
- 89.8
- group Id
- OG004
- spread
- 117
- value
- 175
- group Id
- OG005
- spread
- 17.6
- value
- 446
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 5
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- nab-paclitaxel 120 mg/m\^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).
- id
- OG000
- title
- Phase 1: Nab-Paclitaxel 120 mg/m^2
- description
- nab-paclitaxel 150 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
- id
- OG001
- title
- Phase 1: Nab-Paclitaxel 150 mg/m^2
- description
- nab-paclitaxel 180 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
- id
- OG002
- title
- Phase 1: Nab-Paclitaxel 180 mg/m^2
- description
- nab-paclitaxel 210 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
- id
- OG003
- title
- Phase 1: Nab-Paclitaxel 210 mg/m^2
- description
- nab-paclitaxel 240 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
- id
- OG004
- title
- Phase 1: Nab-Paclitaxel 240 mg/m^2
- description
- nab-paclitaxel 270 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
- id
- OG005
- title
- Phase 1: Nab-Paclitaxel 270 mg/m^2
- param Type
- GEOMETRIC_MEAN
- population Description
- PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)
- title
- Phase 1: Volume of Distribution (Vss)
- type
- SECONDARY
- unit Of Measure
- liters
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice