TriangleNCT03245450 · OUTCOME
Phase 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Eribulin, Irinotecan and Its Active Metabolite SN-38
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
- For eribulin, Cycle 1 Day 1: 0-120 hours post-eribulin infusion; For irinotecan and its metabolite, Cycle 1 Day 1: 0-24 hours post-irinotecan infusion (cycle length=21 days)
Analysis population: PK analysis set included participants who had documented dosing history and at least one post-dosing quantifiable drug concentration.
Groups in this outcome
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 100 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 125 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
| Group | Source count |
|---|---|
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2 | 3 |
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 4 |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2 | 3 |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2 | 3 |
Reported measurements
Eribulin
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2 | 0.080 | 0.03 | 0.03 | 0.22 | Not reported |
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 0.135 | 0.03 | 0.03 | 1 | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2 | 0.080 | 0 | 0 | 0.12 | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2 | 0.050 | 0.01 | 0.01 | 0.12 | Not reported |
Irinotecan
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2 | 0.250 | 0.07 | 0.07 | 0.42 | Not reported |
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 0.305 | 0 | 0 | 24 | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2 | 0.300 | 0.03 | 0.03 | 0.33 | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2 | 0.170 | 0.13 | 0.13 | 0.25 | Not reported |
Active Metabolite SN-38
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2 | 0.420 | 0.25 | 0.25 | 1.03 | Not reported |
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 0.305 | 0 | 0 | 24 | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2 | 0.330 | 0.3 | 0.3 | 0.53 | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2 | 0.250 | 0.13 | 0.13 | 0.55 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- spread
- 0.03
- upper Limit
- 0.22
- value
- 0.080
- group Id
- OG001
- lower Limit
- 0.03
- spread
- 0.03
- upper Limit
- 1
- value
- 0.135
- group Id
- OG002
- lower Limit
- 0
- spread
- 0
- upper Limit
- 0.12
- value
- 0.080
- group Id
- OG003
- lower Limit
- 0.01
- spread
- 0.01
- upper Limit
- 0.12
- value
- 0.050
- title
- Eribulin
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.07
- spread
- 0.07
- upper Limit
- 0.42
- value
- 0.250
- group Id
- OG001
- lower Limit
- 0
- spread
- 0
- upper Limit
- 24
- value
- 0.305
- group Id
- OG002
- lower Limit
- 0.03
- spread
- 0.03
- upper Limit
- 0.33
- value
- 0.300
- group Id
- OG003
- lower Limit
- 0.13
- spread
- 0.13
- upper Limit
- 0.25
- value
- 0.170
- title
- Irinotecan
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.25
- spread
- 0.25
- upper Limit
- 1.03
- value
- 0.420
- group Id
- OG001
- lower Limit
- 0
- spread
- 0
- upper Limit
- 24
- value
- 0.305
- group Id
- OG002
- lower Limit
- 0.3
- spread
- 0.3
- upper Limit
- 0.53
- value
- 0.330
- group Id
- OG003
- lower Limit
- 0.13
- spread
- 0.13
- upper Limit
- 0.55
- value
- 0.250
- title
- Active Metabolite SN-38
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Participants received eribulin mesilate 1.4 mg/m\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- id
- OG000
- title
- Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2
- description
- Participants received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- id
- OG001
- title
- Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- description
- Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 100 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- id
- OG002
- title
- Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2
- description
- Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 125 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- id
- OG003
- title
- Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2
- param Type
- MEDIAN
- population Description
- PK analysis set included participants who had documented dosing history and at least one post-dosing quantifiable drug concentration.
- reporting Status
- POSTED
- time Frame
- For eribulin, Cycle 1 Day 1: 0-120 hours post-eribulin infusion; For irinotecan and its metabolite, Cycle 1 Day 1: 0-24 hours post-irinotecan infusion (cycle length=21 days)
- title
- Phase 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Eribulin, Irinotecan and Its Active Metabolite SN-38
- type
- SECONDARY
- unit Of Measure
- hours
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Preserved source evidence · Not medical advice