TriangleNCT00150462 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
What was measured
Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.
Analysis population: Biologic response-evaluable population
Groups in this outcome
CFZ 1.2 mg/m²
Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 2.4 mg/m²
Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 4.0 mg/m²
Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 6.0 mg/m²
Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 8.4 mg/m²
Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 11.0 mg/m²
Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 15.0 mg/m²
Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 20.0 mg/m²
Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 27.0 mg/m²
Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
CFZ 20/27 mg/m²
Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
CFZ 20/27 mg/m² + DEX
Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
| Group | Source count |
|---|---|
| CFZ 1.2 mg/m² | 1 |
| CFZ 2.4 mg/m² | 2 |
| CFZ 4.0 mg/m² | 3 |
| CFZ 6.0 mg/m² | 2 |
| CFZ 8.4 mg/m² | 3 |
| CFZ 11.0 mg/m² | 3 |
| CFZ 15.0 mg/m² | 2 |
| CFZ 20.0 mg/m² | 6 |
| CFZ 27.0 mg/m² | 5 |
| CFZ 20/27 mg/m² | 6 |
| CFZ 20/27 mg/m² + DEX | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CFZ 1.2 mg/m² | 114.0 | Not reported | 114.0 | 114.0 | Not reported |
| CFZ 2.4 mg/m² | 232.0 | Not reported | 57.0 | 407.0 | Not reported |
| CFZ 4.0 mg/m² | NA | Not reported | 54.0 | 54.0 | Could not be estimated due to the low number of events |
| CFZ 6.0 mg/m² | NA | Not reported | NA | NA | Could not be estimated due to the low number of events |
| CFZ 8.4 mg/m² | 55.0 | Not reported | 47.0 | 55.0 | Not reported |
| CFZ 11.0 mg/m² | 48.0 | Not reported | 15.0 | 176.0 | Not reported |
| CFZ 15.0 mg/m² | 186.0 | Not reported | 50.0 | 322.0 | Not reported |
| CFZ 20.0 mg/m² | 110.5 | Not reported | 15.0 | 190.0 | Not reported |
| CFZ 27.0 mg/m² | 225.0 | Not reported | 36.0 | 330.0 | Not reported |
| CFZ 20/27 mg/m² | NA | Not reported | 15.0 | 99.0 | Could not be estimated due to the low number of events |
| CFZ 20/27 mg/m² + DEX | 49.0 | Not reported | 23.0 | 49.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 114.0
- upper Limit
- 114.0
- value
- 114.0
- group Id
- OG001
- lower Limit
- 57.0
- upper Limit
- 407.0
- value
- 232.0
- comment
- Could not be estimated due to the low number of events
- group Id
- OG002
- lower Limit
- 54.0
- upper Limit
- 54.0
- value
- NA
- comment
- Could not be estimated due to the low number of events
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG004
- lower Limit
- 47.0
- upper Limit
- 55.0
- value
- 55.0
- group Id
- OG005
- lower Limit
- 15.0
- upper Limit
- 176.0
- value
- 48.0
- group Id
- OG006
- lower Limit
- 50.0
- upper Limit
- 322.0
- value
- 186.0
- group Id
- OG007
- lower Limit
- 15.0
- upper Limit
- 190.0
- value
- 110.5
- group Id
- OG008
- lower Limit
- 36.0
- upper Limit
- 330.0
- value
- 225.0
- comment
- Could not be estimated due to the low number of events
- group Id
- OG009
- lower Limit
- 15.0
- upper Limit
- 99.0
- value
- NA
- group Id
- OG010
- lower Limit
- 23.0
- upper Limit
- 49.0
- value
- 49.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 3
- units
- Participants
- description
- Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.
- dispersion Type
- Full Range
- groups
- description
- Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG000
- title
- CFZ 1.2 mg/m²
- description
- Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG001
- title
- CFZ 2.4 mg/m²
- description
- Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG002
- title
- CFZ 4.0 mg/m²
- description
- Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG003
- title
- CFZ 6.0 mg/m²
- description
- Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG004
- title
- CFZ 8.4 mg/m²
- description
- Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG005
- title
- CFZ 11.0 mg/m²
- description
- Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG006
- title
- CFZ 15.0 mg/m²
- description
- Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG007
- title
- CFZ 20.0 mg/m²
- description
- Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
- id
- OG008
- title
- CFZ 27.0 mg/m²
- description
- Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
- id
- OG009
- title
- CFZ 20/27 mg/m²
- description
- Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
- id
- OG010
- title
- CFZ 20/27 mg/m² + DEX
- param Type
- MEDIAN
- population Description
- Biologic response-evaluable population
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice