TriangleNCT01318902 · OUTCOME
Percentage of Participants With One Year Hematologic Disease PFS
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From the date of the first dose of ixazomib to the date of hematologic disease progression or death (Up to 1 year)
What was measured
One-year survival, defined as the patient survival probability at 1 year after the date of first dose of ixazomib.
Analysis population: Safety population included all participants who received at least 1 dose of ixazomib.
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 | 6 |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 0 |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 5 |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 83.3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive) | 80.0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed) | 21.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 83.3
- group Id
- OG002
- value
- 80.0
- group Id
- OG003
- value
- 21.5
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 11
- units
- Participants
- description
- One-year survival, defined as the patient survival probability at 1 year after the date of first dose of ixazomib.
- 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
- NUMBER
- population Description
- Safety population included all participants who received at least 1 dose of ixazomib.
- reporting Status
- POSTED
- time Frame
- From the date of the first dose of ixazomib to the date of hematologic disease progression or death (Up to 1 year)
- title
- Percentage of Participants With One Year Hematologic Disease PFS
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice