TriangleNCT02064387 · OUTCOME
Trough Plasma Concentration (Ctrough) 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
- Nanograms per milliliter
- 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), Pre-dose and EOI of Day 1 (Cycle 2 and Cycle 4)
What was measured
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable. 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 (represented by n=X in the category titles).
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 | 4 |
| Part 1: GSK2857916 0.96 mg/kg | 3 |
| Part 1: GSK2857916 1.92 mg/kg | 4 |
| Part 1: GSK2857916 3.40 mg/kg | 3 |
| Part 1: GSK2857916 4.60 mg/kg | 6 |
Reported measurements
Day 1, Cycle 1,n=0,1,4,2,1,3,3,2,6
| 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 | 2 |
| Part 1: GSK2857916 0.48 mg/kg | 1 |
| Part 1: GSK2857916 0.96 mg/kg | 3 |
| Part 1: GSK2857916 1.92 mg/kg | 3 |
| Part 1: GSK2857916 3.40 mg/kg | 2 |
| Part 1: GSK2857916 4.60 mg/kg | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK2857916 0.06 mg/kg | NA | NA | Not reported | Not reported | NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable. |
| Part 1: GSK2857916 0.12 mg/kg | 381.95 | 105.55 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.24 mg/kg | 1331.11 | 44.43 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.48 mg/kg | 4307.00 | NA | Not reported | Not reported | NA indicates that geometric coefficient of variation could not be calculated for a single participant. |
| Part 1: GSK2857916 0.96 mg/kg | 3720.27 | 113.71 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 11420.61 | 35.70 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 28134.46 | 35.97 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 2301.18 | 75.69 | Not reported | Not reported | Not reported |
Day 1, Cycle 2,n=0,1,0,2,1,2,2,2,5
| 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 | 0 |
| Part 1: GSK2857916 0.24 mg/kg | 2 |
| Part 1: GSK2857916 0.48 mg/kg | 1 |
| Part 1: GSK2857916 0.96 mg/kg | 2 |
| Part 1: GSK2857916 1.92 mg/kg | 2 |
| Part 1: GSK2857916 3.40 mg/kg | 2 |
| Part 1: GSK2857916 4.60 mg/kg | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK2857916 0.06 mg/kg | NA | NA | Not reported | Not reported | NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable. |
| Part 1: GSK2857916 0.24 mg/kg | 1672.18 | 28.76 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.48 mg/kg | 7259.00 | NA | Not reported | Not reported | NA indicates that geometric coefficient of variation could not be calculated for a single participant. |
| Part 1: GSK2857916 0.96 mg/kg | 9510.04 | 104.56 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 12791.83 | 46.82 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 12719.77 | 6.21 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 2643.94 | 123.56 | Not reported | Not reported | Not reported |
Day 1, Cycle 4,n=0,0,0,0,0,0,0,0,0
| Group | Source count |
|---|---|
| Part 1: GSK2857916 0.03 mg/kg | 0 |
| Part 1: GSK2857916 0.06 mg/kg | 0 |
| Part 1: GSK2857916 0.12 mg/kg | 0 |
| Part 1: GSK2857916 0.24 mg/kg | 0 |
| Part 1: GSK2857916 0.48 mg/kg | 0 |
| Part 1: GSK2857916 0.96 mg/kg | 0 |
| Part 1: GSK2857916 1.92 mg/kg | 0 |
| Part 1: GSK2857916 3.40 mg/kg | 0 |
| Part 1: GSK2857916 4.60 mg/kg | 0 |
Complete source fields
- classes
- categories
- measurements
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG002
- spread
- 105.55
- value
- 381.95
- group Id
- OG003
- spread
- 44.43
- value
- 1331.11
- comment
- NA indicates that geometric coefficient of variation could not be calculated for a single participant.
- group Id
- OG004
- spread
- NA
- value
- 4307.00
- group Id
- OG005
- spread
- 113.71
- value
- 3720.27
- group Id
- OG006
- spread
- 35.70
- value
- 11420.61
- group Id
- OG007
- spread
- 35.97
- value
- 28134.46
- group Id
- OG008
- spread
- 75.69
- value
- 2301.18
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 6
- units
- Participants
- title
- Day 1, Cycle 1,n=0,1,4,2,1,3,3,2,6
- categories
- measurements
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 28.76
- value
- 1672.18
- comment
- NA indicates that geometric coefficient of variation could not be calculated for a single participant.
- group Id
- OG004
- spread
- NA
- value
- 7259.00
- group Id
- OG005
- spread
- 104.56
- value
- 9510.04
- group Id
- OG006
- spread
- 46.82
- value
- 12791.83
- group Id
- OG007
- spread
- 6.21
- value
- 12719.77
- group Id
- OG008
- spread
- 123.56
- value
- 2643.94
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 5
- units
- Participants
- title
- Day 1, Cycle 2,n=0,1,0,2,1,2,2,2,5
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Day 1, Cycle 4,n=0,0,0,0,0,0,0,0,0
- 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
- 4
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 4
- 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. NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable. 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 (represented by n=X in the category titles).
- 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), Pre-dose and EOI of Day 1 (Cycle 2 and Cycle 4)
- title
- Trough Plasma Concentration (Ctrough) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1
- type
- SECONDARY
- unit Of Measure
- Nanograms per milliliter
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Preserved source evidence · Not medical advice