TriangleNCT02639546 · OUTCOME
Maximum Plasma Concentration Observed (Cmax) of Cobimetinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21 (predose=within 4 hours prior to dose; cycle length=28 days)
What was measured
Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1. The sampling will allow determination of Cmax.
Analysis population: The PK population was defined as all participants who received at least 1 dose of Cobimetinib and had evaluable PK data. Only participants for whom data were collected are included in the analysis.
Groups in this outcome
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
| Group | Source count |
|---|---|
| Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 6 |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 6 |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 6 |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 6 |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 7 |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 8 |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 5 |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 12 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 6 |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 5 |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 6 |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 6 |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 7 |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 8 |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 4 |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 62.0 | 82.3 | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 88.3 | 102 | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 144 | 58.6 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 51.5 | 73.4 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 67.4 | 165 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 136 | 80.3 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 111 | 37.0 | Not reported | Not reported | Not reported |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 44.0 | 69.8 | Not reported | Not reported | Not reported |
Cycle 1 Day 21
| Group | Source count |
|---|---|
| Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 5 |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 5 |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 5 |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 6 |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 6 |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 8 |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 2 |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 51.1 | 74.0 | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 181 | 134 | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 193 | 35.0 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 105 | 84.5 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 156 | 91.2 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 179 | 113 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 172 | 60.3 | Not reported | Not reported | Not reported |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 116 | 42 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 82.3
- value
- 62.0
- group Id
- OG001
- spread
- 102
- value
- 88.3
- group Id
- OG002
- spread
- 58.6
- value
- 144
- group Id
- OG003
- spread
- 73.4
- value
- 51.5
- group Id
- OG004
- spread
- 165
- value
- 67.4
- group Id
- OG005
- spread
- 80.3
- value
- 136
- group Id
- OG006
- spread
- 37.0
- value
- 111
- group Id
- OG007
- spread
- 69.8
- value
- 44.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 9
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 74.0
- value
- 51.1
- group Id
- OG001
- spread
- 134
- value
- 181
- group Id
- OG002
- spread
- 35.0
- value
- 193
- group Id
- OG003
- spread
- 84.5
- value
- 105
- group Id
- OG004
- spread
- 91.2
- value
- 156
- group Id
- OG005
- spread
- 113
- value
- 179
- group Id
- OG006
- spread
- 60.3
- value
- 172
- group Id
- OG007
- spread
- 42
- value
- 116
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 9
- units
- Participants
- title
- Cycle 1 Day 21
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 12
- units
- Participants
- description
- Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1. The sampling will allow determination of Cmax.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG000
- title
- Phase I (Tablet) Cobimetinib (0.6 mg/kg)
- description
- Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG001
- title
- Phase I (Tablet) Cobimetinib (0.8 mg/kg)
- description
- Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG002
- title
- Phase I (Tablet) Cobimetinib (1 mg/kg)
- description
- Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG003
- title
- Phase I (Suspension) Cobimetinib (0.6 mg/kg)
- description
- Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG004
- title
- Phase I (Suspension) Cobimetinib (0.8 mg/kg)
- description
- Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG005
- title
- Phase I (Suspension) Cobimetinib (1 mg/kg)
- description
- Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG006
- title
- Phase I (Suspension) Cobimetinib (1.33 mg/kg)
- description
- Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG007
- title
- Phase II (Suspension) Cobimetinib (1 mg/kg)
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK population was defined as all participants who received at least 1 dose of Cobimetinib and had evaluable PK data. Only participants for whom data were collected are included in the analysis.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21 (predose=within 4 hours prior to dose; cycle length=28 days)
- title
- Maximum Plasma Concentration Observed (Cmax) of Cobimetinib
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice