TriangleNCT01962103 · OUTCOME
Phase 1: Maximum Observed Concentration of Paclitaxel in Blood Plasma (Cmax)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- 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: Pharmacokinetic (PK) population: all participannts 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 | 13 |
| Phase 1: Nab-Paclitaxel 150 mg/m^2 | 7 |
| Phase 1: Nab-Paclitaxel 180 mg/m^2 | 12 |
| Phase 1: Nab-Paclitaxel 210 mg/m^2 | 9 |
| Phase 1: Nab-Paclitaxel 240 mg/m^2 | 7 |
| Phase 1: Nab-Paclitaxel 270 mg/m^2 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Nab-Paclitaxel 120 mg/m^2 | 3488 | 73.7 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 150 mg/m^2 | 5468 | 38.0 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 180 mg/m^2 | 5597 | 33.4 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 210 mg/m^2 | 5616 | 63.9 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 240 mg/m^2 | 7831 | 23.1 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 270 mg/m^2 | 8078 | 41.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 73.7
- value
- 3488
- group Id
- OG001
- spread
- 38.0
- value
- 5468
- group Id
- OG002
- spread
- 33.4
- value
- 5597
- group Id
- OG003
- spread
- 63.9
- value
- 5616
- group Id
- OG004
- spread
- 23.1
- value
- 7831
- group Id
- OG005
- spread
- 41.5
- value
- 8078
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 6
- 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
- Pharmacokinetic (PK) population: all participannts 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: Maximum Observed Concentration of Paclitaxel in Blood Plasma (Cmax)
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice