TriangleNCT02064387 · OUTCOME
Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Hours
- Interval / dispersion
- Full Range
- Time frame
- Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
What was measured
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Analysis population: PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Groups in this outcome
Part 1: GSK2857916 0.03 mg/kg
Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.06 mg/kg
Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.12 mg/kg
Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.24 mg/kg
Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.48 mg/kg
Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.96 mg/kg
Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 1.92 mg/kg
Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 3.40 mg/kg
Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 4.60 mg/kg
Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
| Group | Source count |
|---|---|
| Part 1: GSK2857916 0.03 mg/kg | 1 |
| Part 1: GSK2857916 0.06 mg/kg | 1 |
| Part 1: GSK2857916 0.12 mg/kg | 4 |
| Part 1: GSK2857916 0.24 mg/kg | 4 |
| Part 1: GSK2857916 0.48 mg/kg | 3 |
| Part 1: GSK2857916 0.96 mg/kg | 3 |
| Part 1: GSK2857916 1.92 mg/kg | 3 |
| Part 1: GSK2857916 3.40 mg/kg | 3 |
| Part 1: GSK2857916 4.60 mg/kg | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK2857916 0.03 mg/kg | 2.080 | Not reported | 2.08 | 2.08 | Not reported |
| Part 1: GSK2857916 0.06 mg/kg | 4.080 | Not reported | 4.08 | 4.08 | Not reported |
| Part 1: GSK2857916 0.12 mg/kg | 1.185 | Not reported | 1.00 | 2.00 | Not reported |
| Part 1: GSK2857916 0.24 mg/kg | 3.085 | Not reported | 2.00 | 8.78 | Not reported |
| Part 1: GSK2857916 0.48 mg/kg | 1.000 | Not reported | 1.00 | 4.00 | Not reported |
| Part 1: GSK2857916 0.96 mg/kg | 2.050 | Not reported | 2.00 | 2.08 | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 1.000 | Not reported | 0.50 | 24.00 | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 6.920 | Not reported | 2.02 | 8.78 | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 1.560 | Not reported | 0.95 | 2.07 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.08
- upper Limit
- 2.08
- value
- 2.080
- group Id
- OG001
- lower Limit
- 4.08
- upper Limit
- 4.08
- value
- 4.080
- group Id
- OG002
- lower Limit
- 1.00
- upper Limit
- 2.00
- value
- 1.185
- group Id
- OG003
- lower Limit
- 2.00
- upper Limit
- 8.78
- value
- 3.085
- group Id
- OG004
- lower Limit
- 1.00
- upper Limit
- 4.00
- value
- 1.000
- group Id
- OG005
- lower Limit
- 2.00
- upper Limit
- 2.08
- value
- 2.050
- group Id
- OG006
- lower Limit
- 0.50
- upper Limit
- 24.00
- value
- 1.000
- group Id
- OG007
- lower Limit
- 2.02
- upper Limit
- 8.78
- value
- 6.920
- group Id
- OG008
- lower Limit
- 0.95
- upper Limit
- 2.07
- value
- 1.560
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 6
- units
- Participants
- description
- Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
- dispersion Type
- Full Range
- groups
- description
- Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG000
- title
- Part 1: GSK2857916 0.03 mg/kg
- description
- Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG001
- title
- Part 1: GSK2857916 0.06 mg/kg
- description
- Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG002
- title
- Part 1: GSK2857916 0.12 mg/kg
- description
- Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG003
- title
- Part 1: GSK2857916 0.24 mg/kg
- description
- Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG004
- title
- Part 1: GSK2857916 0.48 mg/kg
- description
- Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG005
- title
- Part 1: GSK2857916 0.96 mg/kg
- description
- Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG006
- title
- Part 1: GSK2857916 1.92 mg/kg
- description
- Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG007
- title
- Part 1: GSK2857916 3.40 mg/kg
- description
- Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG008
- title
- Part 1: GSK2857916 4.60 mg/kg
- param Type
- MEDIAN
- population Description
- PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
- title
- Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1
- type
- SECONDARY
- unit Of Measure
- Hours
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Preserved source evidence · Not medical advice