TriangleNCT01962103 · OUTCOME
Phase 1: CL - Body Surface Area (BSA)-Normalized
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- L/h/m^2
- 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.)
What was measured
Measurement of renal clearance from the body.
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 | 13.5 | 85.1 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 150 mg/m^2 | 12.5 | 99.3 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 180 mg/m^2 | 17.8 | 38.3 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 210 mg/m^2 | 14.6 | 72.3 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 240 mg/m^2 | 16.7 | 29.2 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 270 mg/m^2 | 21.8 | 28.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 85.1
- value
- 13.5
- group Id
- OG001
- spread
- 99.3
- value
- 12.5
- group Id
- OG002
- spread
- 38.3
- value
- 17.8
- group Id
- OG003
- spread
- 72.3
- value
- 14.6
- group Id
- OG004
- spread
- 29.2
- value
- 16.7
- group Id
- OG005
- spread
- 28.4
- value
- 21.8
- 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
- description
- Measurement of renal clearance from the body.
- 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: CL - Body Surface Area (BSA)-Normalized
- type
- SECONDARY
- unit Of Measure
- L/h/m^2
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice