TriangleNCT02064387 · OUTCOME
Maximum Observed Concentration (Cmax) 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)
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 | 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 | 429.00 | NA | Not reported | Not reported | NA indicates that geometric coefficient of variation could not be calculated for a single participant. |
| Part 1: GSK2857916 0.06 mg/kg | 1323.00 | NA | Not reported | Not reported | NA indicates that geometric coefficient of variation could not be calculated for a single participant. |
| Part 1: GSK2857916 0.12 mg/kg | 2956.77 | 18.45 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.24 mg/kg | 4548.10 | 20.27 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.48 mg/kg | 11876.46 | 24.08 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.96 mg/kg | 23050.05 | 23.05 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 43774.18 | 45.18 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 68128.02 | 20.84 | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 117385.57 | 24.14 | 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
- OG000
- spread
- NA
- value
- 429.00
- comment
- NA indicates that geometric coefficient of variation could not be calculated for a single participant.
- group Id
- OG001
- spread
- NA
- value
- 1323.00
- group Id
- OG002
- spread
- 18.45
- value
- 2956.77
- group Id
- OG003
- spread
- 20.27
- value
- 4548.10
- group Id
- OG004
- spread
- 24.08
- value
- 11876.46
- group Id
- OG005
- spread
- 23.05
- value
- 23050.05
- group Id
- OG006
- spread
- 45.18
- value
- 43774.18
- group Id
- OG007
- spread
- 20.84
- value
- 68128.02
- group Id
- OG008
- spread
- 24.14
- value
- 117385.57
- 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. 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
- Maximum Observed Concentration (Cmax) 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