TriangleNCT00721734 · OUTCOME
Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage of carfilzomib dose
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1, Day 1, 0-5 and 5-24 hours post-dose
What was measured
The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.
Analysis population: Participants in Groups 1-4 with available data
Groups in this outcome
Carfilzomib - Normal RF
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
Carfilzomib - Mild RI
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
Carfilzomib - Moderate RI
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
Carfilzomib - Severe RI
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
| Group | Source count |
|---|---|
| Carfilzomib - Normal RF | 8 |
| Carfilzomib - Mild RI | 9 |
| Carfilzomib - Moderate RI | 7 |
| Carfilzomib - Severe RI | 5 |
| Carfilzomib - Dialysis | 0 |
Reported measurements
M14
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib - Normal RF | 33.1 | 13.1 | Not reported | Not reported | Not reported |
| Carfilzomib - Mild RI | 25.0 | 4.81 | Not reported | Not reported | Not reported |
| Carfilzomib - Moderate RI | 21.7 | 7.59 | Not reported | Not reported | Not reported |
| Carfilzomib - Severe RI | 19.2 | 4.36 | Not reported | Not reported | Not reported |
M15
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib - Normal RF | 1.93 | 1.12 | Not reported | Not reported | Not reported |
| Carfilzomib - Mild RI | 1.42 | 0.314 | Not reported | Not reported | Not reported |
| Carfilzomib - Moderate RI | 0.776 | 0.387 | Not reported | Not reported | Not reported |
| Carfilzomib - Severe RI | 0.578 | 0.230 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.1
- value
- 33.1
- group Id
- OG001
- spread
- 4.81
- value
- 25.0
- group Id
- OG002
- spread
- 7.59
- value
- 21.7
- group Id
- OG003
- spread
- 4.36
- value
- 19.2
- title
- M14
- categories
- measurements
- group Id
- OG000
- spread
- 1.12
- value
- 1.93
- group Id
- OG001
- spread
- 0.314
- value
- 1.42
- group Id
- OG002
- spread
- 0.387
- value
- 0.776
- group Id
- OG003
- spread
- 0.230
- value
- 0.578
- title
- M15
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 0
- units
- Participants
- description
- The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- id
- OG000
- title
- Carfilzomib - Normal RF
- description
- Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- id
- OG001
- title
- Carfilzomib - Mild RI
- description
- Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- id
- OG002
- title
- Carfilzomib - Moderate RI
- description
- Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- id
- OG003
- title
- Carfilzomib - Severe RI
- description
- Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- id
- OG004
- title
- Carfilzomib - Dialysis
- param Type
- MEAN
- population Description
- Participants in Groups 1-4 with available data
- reporting Status
- POSTED
- time Frame
- Cycle 1, Day 1, 0-5 and 5-24 hours post-dose
- title
- Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1
- type
- SECONDARY
- unit Of Measure
- percentage of carfilzomib dose
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice