TriangleNCT01318902 · OUTCOME
Duration of Hematologic Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From the date of first documentation of a hematologic response to the date of hematologic disease progression (Up to approximately 12 months)
What was measured
Duration of hematologic response, measured as the time from the date of first documentation of a hematologic response to the date of hematologic disease progression.
Analysis population: Hematologic response-evaluable population: all participants who received at least 1 cycle of ixazomib, had measureable disease at baseline, had \>=1 postbaseline hematologic response. No participants had hematologic response for ixazomib 5.5 mg arm group thus were not analyzed. Data is reported for participants evaluable for this outcome measure.
Groups in this outcome
Dose Escalation Cohort: Ixazomib 4.0 mg
Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
Dose Escalation Cohort: Ixazomib 5.5 mg
Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)
Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)
Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
| Group | Source count |
|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 4 |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 0 |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 4 |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 12.9 | Not reported | 7.4 | 16.1 | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 69.5 | Not reported | 7.8 | 75.2 | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 19.7 | Not reported | 0.4 | 33.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.4
- upper Limit
- 16.1
- value
- 12.9
- group Id
- OG002
- lower Limit
- 7.8
- upper Limit
- 75.2
- value
- 69.5
- group Id
- OG003
- lower Limit
- 0.4
- upper Limit
- 33.2
- value
- 19.7
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- units
- Participants
- description
- Duration of hematologic response, measured as the time from the date of first documentation of a hematologic response to the date of hematologic disease progression.
- dispersion Type
- Full Range
- groups
- description
- Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
- id
- OG000
- title
- Dose Escalation Cohort: Ixazomib 4.0 mg
- description
- Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
- id
- OG001
- title
- Dose Escalation Cohort: Ixazomib 5.5 mg
- description
- Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
- id
- OG002
- title
- Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)
- description
- Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
- id
- OG003
- title
- Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)
- param Type
- MEDIAN
- population Description
- Hematologic response-evaluable population: all participants who received at least 1 cycle of ixazomib, had measureable disease at baseline, had \>=1 postbaseline hematologic response. No participants had hematologic response for ixazomib 5.5 mg arm group thus were not analyzed. Data is reported for participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From the date of first documentation of a hematologic response to the date of hematologic disease progression (Up to approximately 12 months)
- title
- Duration of Hematologic Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice