TriangleNCT01383928 · OUTCOME
Phase 1: Rac: Accumulation Ratio of Ixazomib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ratio
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1, Days 1 and 11
What was measured
The accumulation ratio (Rac) was estimated as the ratio of AUC (0-72) on Day 11 to the AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours post-dose for ixazomib.
Analysis population: PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.
Groups in this outcome
Phase 1: Ixazomib 3 mg
Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
Phase 1: Ixazomib 3.7 mg
Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
| Group | Source count |
|---|---|
| Phase 1: Ixazomib 3 mg | 5 |
| Phase 1: Ixazomib 3.7 mg | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Ixazomib 3 mg | 3.785 | 1.4653 | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 3.7 mg | 3.967 | 0.7546 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.4653
- value
- 3.785
- group Id
- OG001
- spread
- 0.7546
- value
- 3.967
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- The accumulation ratio (Rac) was estimated as the ratio of AUC (0-72) on Day 11 to the AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours post-dose for ixazomib.
- dispersion Type
- Standard Deviation
- groups
- description
- Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
- id
- OG000
- title
- Phase 1: Ixazomib 3 mg
- description
- Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
- id
- OG001
- title
- Phase 1: Ixazomib 3.7 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.
- reporting Status
- POSTED
- time Frame
- Cycle 1, Days 1 and 11
- title
- Phase 1: Rac: Accumulation Ratio of Ixazomib
- type
- SECONDARY
- unit Of Measure
- ratio
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Preserved source evidence · Not medical advice