TriangleNCT02171260 · OUTCOME
T1/2: Terminal Half-life for Eribulin Mesylate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose
Analysis population: The pharmacokinetic analysis set (PAS) included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available.
Groups in this outcome
Part A1: Eribulin Mesylate 1.1 mg/m^2
Participants received eribulin mesylate 1.1 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up 4 cycles, or until PD or unacceptable toxicity or DLT's.
Part A1: Eribulin Mesylate 1.4 mg/m^2
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
Part A1: Eribulin Mesylate 1.8 mg/m^2
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
Part A1: Eribulin Mesylate PK Expansion
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
| Group | Source count |
|---|---|
| Part A1: Eribulin Mesylate 1.1 mg/m^2 | 3 |
| Part A1: Eribulin Mesylate 1.4 mg/m^2 | 6 |
| Part A1: Eribulin Mesylate 1.8 mg/m^2 | 5 |
| Part A1: Eribulin Mesylate PK Expansion | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A1: Eribulin Mesylate 1.1 mg/m^2 | 37.00 | Not reported | 29.6 | 38.9 | Not reported |
| Part A1: Eribulin Mesylate 1.4 mg/m^2 | 38.60 | Not reported | 23.3 | 44.3 | Not reported |
| Part A1: Eribulin Mesylate 1.8 mg/m^2 | 44.00 | Not reported | 30.6 | 56.5 | Not reported |
| Part A1: Eribulin Mesylate PK Expansion | 33.25 | Not reported | 30.2 | 45.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.6
- upper Limit
- 38.9
- value
- 37.00
- group Id
- OG001
- lower Limit
- 23.3
- upper Limit
- 44.3
- value
- 38.60
- group Id
- OG002
- lower Limit
- 30.6
- upper Limit
- 56.5
- value
- 44.00
- group Id
- OG003
- lower Limit
- 30.2
- upper Limit
- 45.9
- value
- 33.25
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 4
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Participants received eribulin mesylate 1.1 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up 4 cycles, or until PD or unacceptable toxicity or DLT's.
- id
- OG000
- title
- Part A1: Eribulin Mesylate 1.1 mg/m^2
- description
- Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
- id
- OG001
- title
- Part A1: Eribulin Mesylate 1.4 mg/m^2
- description
- Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
- id
- OG002
- title
- Part A1: Eribulin Mesylate 1.8 mg/m^2
- description
- Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
- id
- OG003
- title
- Part A1: Eribulin Mesylate PK Expansion
- param Type
- MEDIAN
- population Description
- The pharmacokinetic analysis set (PAS) included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available.
- reporting Status
- POSTED
- time Frame
- Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose
- title
- T1/2: Terminal Half-life for Eribulin Mesylate
- type
- PRIMARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice