TriangleNCT03245450 · OUTCOME
Phase 1, Cmax: Maximum Observed Plasma Concentration 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
- GEOMETRIC_MEAN
- Unit
- nanogram/milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- 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 | 369.3 | 58.0 | 58.0 | Not reported | Not reported |
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 179.4 | 136.1 | 136.1 | Not reported | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2 | 348.7 | 25.0 | 25.0 | Not reported | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2 | 323.3 | 20.6 | 20.6 | Not reported | 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 | 538.8 | 165.9 | 165.9 | Not reported | Not reported |
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 399.5 | 19.1 | 19.1 | Not reported | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2 | 1168.1 | 39.8 | 39.8 | Not reported | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2 | 1555.4 | 39.5 | 39.5 | Not reported | 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 | 6.518 | 9.4 | 9.4 | Not reported | Not reported |
| Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 17.170 | 39.7 | 39.7 | Not reported | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2 | 25.409 | 51.6 | 51.6 | Not reported | Not reported |
| Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2 | 18.614 | 74.3 | 74.3 | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 58.0
- spread
- 58.0
- value
- 369.3
- group Id
- OG001
- lower Limit
- 136.1
- spread
- 136.1
- value
- 179.4
- group Id
- OG002
- lower Limit
- 25.0
- spread
- 25.0
- value
- 348.7
- group Id
- OG003
- lower Limit
- 20.6
- spread
- 20.6
- value
- 323.3
- title
- Eribulin
- categories
- measurements
- group Id
- OG000
- lower Limit
- 165.9
- spread
- 165.9
- value
- 538.8
- group Id
- OG001
- lower Limit
- 19.1
- spread
- 19.1
- value
- 399.5
- group Id
- OG002
- lower Limit
- 39.8
- spread
- 39.8
- value
- 1168.1
- group Id
- OG003
- lower Limit
- 39.5
- spread
- 39.5
- value
- 1555.4
- title
- Irinotecan
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.4
- spread
- 9.4
- value
- 6.518
- group Id
- OG001
- lower Limit
- 39.7
- spread
- 39.7
- value
- 17.170
- group Id
- OG002
- lower Limit
- 51.6
- spread
- 51.6
- value
- 25.409
- group Id
- OG003
- lower Limit
- 74.3
- spread
- 74.3
- value
- 18.614
- 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
- Geometric Coefficient of Variation
- 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
- GEOMETRIC_MEAN
- 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, Cmax: Maximum Observed Plasma Concentration of Eribulin, Irinotecan and Its Active Metabolite SN-38
- type
- SECONDARY
- unit Of Measure
- nanogram/milliliter (ng/mL)
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Preserved source evidence · Not medical advice