TriangleNCT02303821 · OUTCOME
Phase 1b: AUC From Time 0 to Infinity (AUCinf) of Carfilzomib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- hr*ng/ mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15m after the start of infusion, immediately (within 2m) before the EOI, EOI, 10m, 30m, 1h, 2 h, and 4h post-dose
What was measured
The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.
Analysis population: Phase 1b PK Analysis Set: All participants who received the study treatment regimen during the lead-in cycle and induction cycles, and had available data. Phase 1b Dose Escalation 2 arms did not have a 1-week lead-in cycle.
Groups in this outcome
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
| Group | Source count |
|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 5 |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 5 |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 1 |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 5 |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 3 |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 5 |
Reported measurements
Dose Escalation 1 - Lead in Cycle Day 1
| Group | Source count |
|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 5 |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 5 |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 0 |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 0 |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 0 |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 387 | 124 | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 268 | 101 | Not reported | Not reported | Not reported |
Induction Cycle Day 8
| Group | Source count |
|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 4 |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 4 |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 1 |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 5 |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 3 |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 368 | 184 | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 374 | 273 | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 406 | 0.0 | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 565 | 243 | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 848 | 510 | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 1300 | 1440 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 124
- value
- 387
- group Id
- OG001
- spread
- 101
- value
- 268
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- units
- Participants
- title
- Dose Escalation 1 - Lead in Cycle Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 184
- value
- 368
- group Id
- OG001
- spread
- 273
- value
- 374
- group Id
- OG002
- spread
- 0.0
- value
- 406
- group Id
- OG003
- spread
- 243
- value
- 565
- group Id
- OG004
- spread
- 510
- value
- 848
- group Id
- OG005
- spread
- 1440
- value
- 1300
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 5
- units
- Participants
- title
- Induction Cycle Day 8
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 5
- units
- Participants
- description
- The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG000
- title
- Phase 1b: Dose Escalation 1 (20 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG001
- title
- Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG002
- title
- Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG003
- title
- Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG004
- title
- Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG005
- title
- Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
- param Type
- MEAN
- population Description
- Phase 1b PK Analysis Set: All participants who received the study treatment regimen during the lead-in cycle and induction cycles, and had available data. Phase 1b Dose Escalation 2 arms did not have a 1-week lead-in cycle.
- reporting Status
- POSTED
- time Frame
- Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15m after the start of infusion, immediately (within 2m) before the EOI, EOI, 10m, 30m, 1h, 2 h, and 4h post-dose
- title
- Phase 1b: AUC From Time 0 to Infinity (AUCinf) of Carfilzomib
- type
- SECONDARY
- unit Of Measure
- hr*ng/ mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice