TriangleNCT02064387 · OUTCOME
Clearance (CL) 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
- GEOMETRIC_MEAN
- Unit
- Milliliter per hour
- Interval / dispersion
- Geometric Coefficient of Variation
- 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. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
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 | 0 |
| Part 1: GSK2857916 0.06 mg/kg | 1 |
| Part 1: GSK2857916 0.12 mg/kg | 4 |
| Part 1: GSK2857916 0.24 mg/kg | 3 |
| Part 1: GSK2857916 0.48 mg/kg | 3 |
| Part 1: GSK2857916 0.96 mg/kg | 2 |
| Part 1: GSK2857916 1.92 mg/kg | 1 |
| Part 1: GSK2857916 3.40 mg/kg | 0 |
| Part 1: GSK2857916 4.60 mg/kg | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK2857916 0.06 mg/kg | 28.27 | NA | Not reported | Not reported | NA indicates that geometric coefficient of variation could not be calculated for a single participant. |
| Part 1: GSK2857916 0.12 mg/kg | 10.53 | 58.94 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.24 mg/kg | 25.01 | 88.61 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.48 mg/kg | 15.10 | 75.16 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.96 mg/kg | 8.46 | 27.46 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 11.68 | NA | Not reported | Not reported | NA indicates that geometric coefficient of variation could not be calculated for a single participant. |
| Part 1: GSK2857916 4.60 mg/kg | 38.84 | 37.53 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- NA indicates that geometric coefficient of variation could not be calculated for a single participant.
- group Id
- OG001
- spread
- NA
- value
- 28.27
- group Id
- OG002
- spread
- 58.94
- value
- 10.53
- group Id
- OG003
- spread
- 88.61
- value
- 25.01
- group Id
- OG004
- spread
- 75.16
- value
- 15.10
- group Id
- OG005
- spread
- 27.46
- value
- 8.46
- comment
- NA indicates that geometric coefficient of variation could not be calculated for a single participant.
- group Id
- OG006
- spread
- NA
- value
- 11.68
- group Id
- OG008
- spread
- 37.53
- value
- 38.84
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 4
- units
- Participants
- description
- Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
- dispersion Type
- Geometric Coefficient of Variation
- 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
- GEOMETRIC_MEAN
- 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
- Clearance (CL) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1
- type
- SECONDARY
- unit Of Measure
- Milliliter per hour
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Preserved source evidence · Not medical advice