TriangleNCT02064387 · OUTCOME
Ctrough of Cys-mcMMAF Following IV Dose of GSK2857916 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
- Picograms 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 Cys-mcMMAF 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.
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 | 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 | 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 0.48 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 0.96 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 1.92 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 3.40 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 4.60 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. |
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 | 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 0.48 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 0.96 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 1.92 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 3.40 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 4.60 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. |
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
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG002
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG003
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG004
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG005
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG006
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG007
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG008
- spread
- NA
- value
- NA
- 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
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG003
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG004
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG005
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG006
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG007
- spread
- NA
- value
- NA
- comment
- NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
- group Id
- OG008
- spread
- NA
- value
- NA
- 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 Cys-mcMMAF 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.
- 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
- Ctrough of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1
- type
- SECONDARY
- unit Of Measure
- Picograms per milliliter
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Preserved source evidence · Not medical advice