TriangleNCT02639546 · OUTCOME
Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of Cobimetinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hr*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 (pre-dose=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 AUC0-24.
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) | 6 |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 8 |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 3 |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 865 | 83.0 | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 1006 | 100 | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 1432 | 50.0 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 743 | 67.4 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 1111 | 144 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 1627 | 74.0 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 1567 | 33.1 | Not reported | Not reported | Not reported |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 589 | 79.5 | 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) | 836 | 83.5 | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 2802 | 111 | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 2382 | 38.4 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 1624 | 80.4 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 1805 | 109 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 2562 | 104 | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 2511 | 104 | Not reported | Not reported | Not reported |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 1402 | 59 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 83.0
- value
- 865
- group Id
- OG001
- spread
- 100
- value
- 1006
- group Id
- OG002
- spread
- 50.0
- value
- 1432
- group Id
- OG003
- spread
- 67.4
- value
- 743
- group Id
- OG004
- spread
- 144
- value
- 1111
- group Id
- OG005
- spread
- 74.0
- value
- 1627
- group Id
- OG006
- spread
- 33.1
- value
- 1567
- group Id
- OG007
- spread
- 79.5
- value
- 589
- 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
- 6
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 9
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 83.5
- value
- 836
- group Id
- OG001
- spread
- 111
- value
- 2802
- group Id
- OG002
- spread
- 38.4
- value
- 2382
- group Id
- OG003
- spread
- 80.4
- value
- 1624
- group Id
- OG004
- spread
- 109
- value
- 1805
- group Id
- OG005
- spread
- 104
- value
- 2562
- group Id
- OG006
- spread
- 104
- value
- 2511
- group Id
- OG007
- spread
- 59
- value
- 1402
- 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 AUC0-24.
- 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 (pre-dose=within 4 hours prior to dose; cycle length=28 days)
- title
- Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of Cobimetinib
- type
- SECONDARY
- unit Of Measure
- hr*ng/mL
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Preserved source evidence · Not medical advice