TriangleNCT01962103 · OUTCOME
Phase 1: AUC - Dose-Normalized
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*h/mL/[mg]
- 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
Measurements include: AUC24 and AUCinf.
Analysis population: PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data for given measure.
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 | 8 |
| Phase 1: Nab-Paclitaxel 240 mg/m^2 | 7 |
| Phase 1: Nab-Paclitaxel 270 mg/m^2 | 6 |
Reported measurements
AUC24
| 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 | 8 |
| Phase 1: Nab-Paclitaxel 240 mg/m^2 | 7 |
| Phase 1: Nab-Paclitaxel 270 mg/m^2 | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Nab-Paclitaxel 120 mg/m^2 | 42.7 | 77.4 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 150 mg/m^2 | 41.6 | 87.0 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 180 mg/m^2 | 40.8 | 39.7 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 210 mg/m^2 | 43.3 | 63.6 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 240 mg/m^2 | 40.2 | 65.4 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 270 mg/m^2 | 25.4 | 26.1 | Not reported | Not reported | Not reported |
AUCinf
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Nab-Paclitaxel 120 mg/m^2 | 62.0 | 75.7 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 150 mg/m^2 | 49.2 | 101 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 180 mg/m^2 | 47.8 | 39.8 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 210 mg/m^2 | 64.8 | 25.4 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 240 mg/m^2 | 52.3 | 67.4 | Not reported | Not reported | Not reported |
| Phase 1: Nab-Paclitaxel 270 mg/m^2 | 31.3 | 34.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 77.4
- value
- 42.7
- group Id
- OG001
- spread
- 87.0
- value
- 41.6
- group Id
- OG002
- spread
- 39.7
- value
- 40.8
- group Id
- OG003
- spread
- 63.6
- value
- 43.3
- group Id
- OG004
- spread
- 65.4
- value
- 40.2
- group Id
- OG005
- spread
- 26.1
- value
- 25.4
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- AUC24
- categories
- measurements
- group Id
- OG000
- spread
- 75.7
- value
- 62.0
- group Id
- OG001
- spread
- 101
- value
- 49.2
- group Id
- OG002
- spread
- 39.8
- value
- 47.8
- group Id
- OG003
- spread
- 25.4
- value
- 64.8
- group Id
- OG004
- spread
- 67.4
- value
- 52.3
- group Id
- OG005
- spread
- 34.9
- value
- 31.3
- 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
- title
- AUCinf
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 6
- units
- Participants
- description
- Measurements include: AUC24 and AUCinf.
- 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 for given measure.
- 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: AUC - Dose-Normalized
- type
- SECONDARY
- unit Of Measure
- ng*h/mL/[mg]
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Preserved source evidence · Not medical advice