TriangleNCT02514239 · OUTCOME
Serum Concentration at Steady State of BI 836909 (Css)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- picogram/milliliter (pg/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pharmacokinetic samples were collected at 48:00 hours (h):minutes (min), 168:00, 336:00, 504:00 and 671:50 h after the start of infusion of BI 836909 of the first cycle.
What was measured
Serum concentration at steady state of BI 836909 (Css).
Analysis population: PK Analysis Set (PKS): all evaluable patients in the treated set which provide at least one evaluable observation for at least one PK endpoint.
Groups in this outcome
Intravenous Infusion of BI 836909 (0.2 μg/d)
Intravenous infusion of BI 836909 (0.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (0.4 μg/d)
Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (0.8 μg/d)
Intravenous infusion of BI 836909 (0.8 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (1.6 μg/d)
Intravenous infusion of BI 836909 (1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
| Group | Source count |
|---|---|
| Intravenous Infusion of BI 836909 (0.2 μg/d) | 1 |
| Intravenous Infusion of BI 836909 (0.4 μg/d) | 1 |
| Intravenous Infusion of BI 836909 (0.8 μg/d) | 2 |
| Intravenous Infusion of BI 836909 (1.6 μg/d) | 1 |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (13 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (25 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (50 μg/d) | 5 |
| Intravenous Infusion of BI 836909 (100 μg/d) | 4 |
| Intravenous Infusion of BI 836909 (200 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (400 μg/d) | 9 |
| Intravenous Infusion of BI 836909 (800 μg/d) | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous Infusion of BI 836909 (0.2 μg/d) | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation could not be calculated because the serum concentrations of BI 836909 were below limit of quantitation (BLQ) for 0.2 ug/day. |
| Intravenous Infusion of BI 836909 (0.4 μg/d) | 86.5 | NA | Not reported | Not reported | Geometric Coefficient of Variation could not be calculated because of the limited sample size. |
| Intravenous Infusion of BI 836909 (0.8 μg/d) | 90.8 | 41.1 | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (1.6 μg/d) | 184 | NA | Not reported | Not reported | Geometric Coefficient of Variation could not be calculated because of the limited sample size. |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 526 | 34.7 | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 1070 | 67.3 | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 2180 | 34.6 | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 4130 | 30.7 | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 10700 | 55.4 | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 9810 | 47.6 | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 14100 | 121 | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 29900 | 54.3 | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 33000 | 41.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric Mean and Geometric Coefficient of Variation could not be calculated because the serum concentrations of BI 836909 were below limit of quantitation (BLQ) for 0.2 ug/day.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Geometric Coefficient of Variation could not be calculated because of the limited sample size.
- group Id
- OG001
- spread
- NA
- value
- 86.5
- group Id
- OG002
- spread
- 41.1
- value
- 90.8
- comment
- Geometric Coefficient of Variation could not be calculated because of the limited sample size.
- group Id
- OG003
- spread
- NA
- value
- 184
- group Id
- OG004
- spread
- 34.7
- value
- 526
- group Id
- OG005
- spread
- 67.3
- value
- 1070
- group Id
- OG006
- spread
- 34.6
- value
- 2180
- group Id
- OG007
- spread
- 30.7
- value
- 4130
- group Id
- OG008
- spread
- 55.4
- value
- 10700
- group Id
- OG009
- spread
- 47.6
- value
- 9810
- group Id
- OG010
- spread
- 121
- value
- 14100
- group Id
- OG011
- spread
- 54.3
- value
- 29900
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 9
- units
- Participants
- description
- Serum concentration at steady state of BI 836909 (Css).
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Intravenous infusion of BI 836909 (0.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG000
- title
- Intravenous Infusion of BI 836909 (0.2 μg/d)
- description
- Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG001
- title
- Intravenous Infusion of BI 836909 (0.4 μg/d)
- description
- Intravenous infusion of BI 836909 (0.8 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG002
- title
- Intravenous Infusion of BI 836909 (0.8 μg/d)
- description
- Intravenous infusion of BI 836909 (1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG003
- title
- Intravenous Infusion of BI 836909 (1.6 μg/d)
- description
- Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG004
- title
- Intravenous Infusion of BI 836909 (3.2 μg/d)
- description
- Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG005
- title
- Intravenous Infusion of BI 836909 (6.5 μg/d)
- description
- Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles
- id
- OG006
- title
- Intravenous Infusion of BI 836909 (13 μg/d)
- description
- Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG007
- title
- Intravenous Infusion of BI 836909 (25 μg/d)
- description
- Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG008
- title
- Intravenous Infusion of BI 836909 (50 μg/d)
- description
- Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG009
- title
- Intravenous Infusion of BI 836909 (100 μg/d)
- description
- Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG010
- title
- Intravenous Infusion of BI 836909 (200 μg/d)
- description
- Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG011
- title
- Intravenous Infusion of BI 836909 (400 μg/d)
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Analysis Set (PKS): all evaluable patients in the treated set which provide at least one evaluable observation for at least one PK endpoint.
- reporting Status
- POSTED
- time Frame
- Pharmacokinetic samples were collected at 48:00 hours (h):minutes (min), 168:00, 336:00, 504:00 and 671:50 h after the start of infusion of BI 836909 of the first cycle.
- title
- Serum Concentration at Steady State of BI 836909 (Css)
- type
- SECONDARY
- unit Of Measure
- picogram/milliliter (pg/mL)
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Preserved source evidence · Not medical advice