TriangleNCT01556438 · OUTCOME
Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Plasma Concentration (AUC0-tlast) of Tabalumab (LY2127399)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hours times nanograms per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab
Analysis population: All participants who received at least 1 dose of any study drug and had evaluable PK data.
Groups in this outcome
100 mg Tabalumab+BTZ IV+Dex
Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ. LY2127399: Administered IV Bortezomib IV: Administered IV Dexamethasone: Administered orally
300 mg Tabalumab IV BTZ +Dex
Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ IV.
300 mg Tabalumab+ SC BTZ +Dex
Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
| Group | Source count |
|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 4 |
| 300 mg Tabalumab IV BTZ +Dex | 4 |
| 300 mg Tabalumab+ SC BTZ +Dex | 8 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 4 |
| 300 mg Tabalumab IV BTZ +Dex | 4 |
| 300 mg Tabalumab+ SC BTZ +Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 8100 | 15 | Not reported | Not reported | Not reported |
| 300 mg Tabalumab IV BTZ +Dex | 34600 | 23 | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+ SC BTZ +Dex | 26900 | 48 | Not reported | Not reported | Not reported |
Cycle 7 Day 1
| Group | Source count |
|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 1 |
| 300 mg Tabalumab IV BTZ +Dex | 1 |
| 300 mg Tabalumab+ SC BTZ +Dex | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 9400 | NA | Not reported | Not reported | N of 1, Individual data presented, no CV value. |
| 300 mg Tabalumab IV BTZ +Dex | 27300 | NA | Not reported | Not reported | N of 1, Individual data presented, no CV value. |
| 300 mg Tabalumab+ SC BTZ +Dex | 22900 | 71 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15
- value
- 8100
- group Id
- OG001
- spread
- 23
- value
- 34600
- group Id
- OG002
- spread
- 48
- value
- 26900
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 8
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- comment
- N of 1, Individual data presented, no CV value.
- group Id
- OG000
- spread
- NA
- value
- 9400
- comment
- N of 1, Individual data presented, no CV value.
- group Id
- OG001
- spread
- NA
- value
- 27300
- group Id
- OG002
- spread
- 71
- value
- 22900
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- units
- Participants
- title
- Cycle 7 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 8
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ. LY2127399: Administered IV Bortezomib IV: Administered IV Dexamethasone: Administered orally
- id
- OG000
- title
- 100 mg Tabalumab+BTZ IV+Dex
- description
- Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ IV.
- id
- OG001
- title
- 300 mg Tabalumab IV BTZ +Dex
- description
- Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
- id
- OG002
- title
- 300 mg Tabalumab+ SC BTZ +Dex
- param Type
- GEOMETRIC_MEAN
- population Description
- All participants who received at least 1 dose of any study drug and had evaluable PK data.
- reporting Status
- POSTED
- time Frame
- Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab
- title
- Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Plasma Concentration (AUC0-tlast) of Tabalumab (LY2127399)
- type
- SECONDARY
- unit Of Measure
- hours times nanograms per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice