TriangleNCT02457793 · OUTCOME
Total Exposure (AUC From Time 0 to 24 Hour After Dose) for GDC-0994
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hr x microM
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- 0 to 24 hours post-dose (Up to Day 22)
What was measured
Data are reported for evaluable participants.
Analysis population: Data are reported for evaluable participants.
Groups in this outcome
COB 80 mg + GDC 300 mg
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.
COB 20 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 40 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 80 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 80 mg + GDC 400 mg
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
COB 100 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
| Group | Source count |
|---|---|
| COB 80 mg + GDC 300 mg | 1 |
| COB 20 mg + GDC 200 mg | 5 |
| COB 40 mg + GDC 200 mg | 3 |
| COB 80 mg + GDC 200 mg | 5 |
| COB 80 mg + GDC 400 mg | 4 |
| COB 100 mg + GDC 200 mg | 6 |
Reported measurements
Day 1
| Group | Source count |
|---|---|
| COB 80 mg + GDC 300 mg | 0 |
| COB 20 mg + GDC 200 mg | 5 |
| COB 40 mg + GDC 200 mg | 3 |
| COB 80 mg + GDC 200 mg | 5 |
| COB 80 mg + GDC 400 mg | 4 |
| COB 100 mg + GDC 200 mg | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| COB 20 mg + GDC 200 mg | 37.0 | 45.9 | Not reported | Not reported | Not reported |
| COB 40 mg + GDC 200 mg | 32.9 | 55.4 | Not reported | Not reported | Not reported |
| COB 80 mg + GDC 200 mg | 27.9 | 93.8 | Not reported | Not reported | Not reported |
| COB 80 mg + GDC 400 mg | 37.8 | 37.5 | Not reported | Not reported | Not reported |
| COB 100 mg + GDC 200 mg | 37.7 | 81.0 | Not reported | Not reported | Not reported |
Steady State
| Group | Source count |
|---|---|
| COB 80 mg + GDC 300 mg | 1 |
| COB 20 mg + GDC 200 mg | 2 |
| COB 40 mg + GDC 200 mg | 1 |
| COB 80 mg + GDC 200 mg | 3 |
| COB 80 mg + GDC 400 mg | 1 |
| COB 100 mg + GDC 200 mg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| COB 80 mg + GDC 300 mg | 48.3 | Not reported | Not reported | Not reported | Not reported |
| COB 20 mg + GDC 200 mg | 23.5 | 73.4 | Not reported | Not reported | Not reported |
| COB 40 mg + GDC 200 mg | 24.1 | Not reported | Not reported | Not reported | Not reported |
| COB 80 mg + GDC 200 mg | 33.3 | 66.4 | Not reported | Not reported | Not reported |
| COB 80 mg + GDC 400 mg | 37.2 | Not reported | Not reported | Not reported | Not reported |
| COB 100 mg + GDC 200 mg | 34.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- spread
- 45.9
- value
- 37.0
- group Id
- OG002
- spread
- 55.4
- value
- 32.9
- group Id
- OG003
- spread
- 93.8
- value
- 27.9
- group Id
- OG004
- spread
- 37.5
- value
- 37.8
- group Id
- OG005
- spread
- 81.0
- value
- 37.7
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- value
- 48.3
- group Id
- OG001
- spread
- 73.4
- value
- 23.5
- group Id
- OG002
- value
- 24.1
- group Id
- OG003
- spread
- 66.4
- value
- 33.3
- group Id
- OG004
- value
- 37.2
- group Id
- OG005
- value
- 34.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- Steady State
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- units
- Participants
- description
- Data are reported for evaluable participants.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.
- id
- OG000
- title
- COB 80 mg + GDC 300 mg
- description
- Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
- id
- OG001
- title
- COB 20 mg + GDC 200 mg
- description
- Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
- id
- OG002
- title
- COB 40 mg + GDC 200 mg
- description
- Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
- id
- OG003
- title
- COB 80 mg + GDC 200 mg
- description
- Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
- id
- OG004
- title
- COB 80 mg + GDC 400 mg
- description
- Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
- id
- OG005
- title
- COB 100 mg + GDC 200 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- Data are reported for evaluable participants.
- reporting Status
- POSTED
- time Frame
- 0 to 24 hours post-dose (Up to Day 22)
- title
- Total Exposure (AUC From Time 0 to 24 Hour After Dose) for GDC-0994
- type
- SECONDARY
- unit Of Measure
- hr x microM
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice