TriangleNCT02418000 · OUTCOME
Pharmacokinetic Profile of E6201 in Plasma: AUCT
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- h.ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.
What was measured
Area under the plasma concentration versus time curve (AUC) to the last measurable concentration over the sampling time-interval.
Analysis population: All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.
Groups in this outcome
E6201 240 mg/m^2 Weekly
Cohort 1: Participants were administered E6201 240 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
E6201 320 mg/m^2 Weekly
Cohort 2: Participants were administered E6201 320 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
E6201 160 mg/m^2 Twice Weekly
Cohort 3: Participants were administered E6201 160 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
E6201 240 mg/m^2 Twice Weekly
Cohort 4: Participants were administered E6201 240 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
E6201 320 mg/m^2 Twice Weekly
Cohort 5: Participants were administered E6201 320 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
| Group | Source count |
|---|---|
| E6201 240 mg/m^2 Weekly | 7 |
| E6201 320 mg/m^2 Weekly | 10 |
| E6201 160 mg/m^2 Twice Weekly | 3 |
| E6201 240 mg/m^2 Twice Weekly | 3 |
| E6201 320 mg/m^2 Twice Weekly | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| E6201 240 mg/m^2 Weekly | 3797.76 | 20.6 | Not reported | Not reported | Not reported |
| E6201 320 mg/m^2 Weekly | 8135.24 | 88.0 | Not reported | Not reported | Not reported |
| E6201 160 mg/m^2 Twice Weekly | 3034.10 | 69.8 | Not reported | Not reported | Not reported |
| E6201 240 mg/m^2 Twice Weekly | 2796.73 | 50.3 | Not reported | Not reported | Not reported |
| E6201 320 mg/m^2 Twice Weekly | 6082.79 | 23.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 20.6
- value
- 3797.76
- group Id
- OG001
- spread
- 88.0
- value
- 8135.24
- group Id
- OG002
- spread
- 69.8
- value
- 3034.10
- group Id
- OG003
- spread
- 50.3
- value
- 2796.73
- group Id
- OG004
- spread
- 23.0
- value
- 6082.79
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- units
- Participants
- description
- Area under the plasma concentration versus time curve (AUC) to the last measurable concentration over the sampling time-interval.
- dispersion Type
- Standard Deviation
- groups
- description
- Cohort 1: Participants were administered E6201 240 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
- id
- OG000
- title
- E6201 240 mg/m^2 Weekly
- description
- Cohort 2: Participants were administered E6201 320 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
- id
- OG001
- title
- E6201 320 mg/m^2 Weekly
- description
- Cohort 3: Participants were administered E6201 160 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
- id
- OG002
- title
- E6201 160 mg/m^2 Twice Weekly
- description
- Cohort 4: Participants were administered E6201 240 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
- id
- OG003
- title
- E6201 240 mg/m^2 Twice Weekly
- description
- Cohort 5: Participants were administered E6201 320 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
- id
- OG004
- title
- E6201 320 mg/m^2 Twice Weekly
- param Type
- MEAN
- population Description
- All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.
- reporting Status
- POSTED
- time Frame
- Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.
- title
- Pharmacokinetic Profile of E6201 in Plasma: AUCT
- type
- SECONDARY
- unit Of Measure
- h.ng/mL
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Preserved source evidence · Not medical advice