TriangleNCT01072175 · OUTCOME
Part D: Cmax Assessment of Trametinib
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
- 95% Confidence Interval
- Time frame
- Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose
What was measured
Cmax of trametinib after single and repeat dose in combination with DAB was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, Cmax was not analyzed in these participants at Days 1 and 21.
Analysis population: PK Population. Only participants who were available at the indicated timepoints were analyzed.
Groups in this outcome
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
Part D: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
| Group | Source count |
|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 15 |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 14 |
Reported measurements
Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 6.8 | Not reported | 5 | 10 | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 6.6 | Not reported | 4 | 10 | Not reported |
Day 21
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 24.1 | Not reported | 20 | 29 | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 22.6 | Not reported | 20 | 26 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG002
- lower Limit
- 5
- upper Limit
- 10
- value
- 6.8
- group Id
- OG003
- lower Limit
- 4
- upper Limit
- 10
- value
- 6.6
- title
- Day 1
- categories
- measurements
- group Id
- OG002
- lower Limit
- 20
- upper Limit
- 29
- value
- 24.1
- group Id
- OG003
- lower Limit
- 20
- upper Limit
- 26
- value
- 22.6
- title
- Day 21
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 14
- units
- Participants
- description
- Cmax of trametinib after single and repeat dose in combination with DAB was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, Cmax was not analyzed in these participants at Days 1 and 21.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
- id
- OG000
- title
- Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
- id
- OG001
- title
- Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
- id
- OG002
- title
- Part D: Dabrafenib 75 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
- id
- OG003
- title
- Part D: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Population. Only participants who were available at the indicated timepoints were analyzed.
- reporting Status
- POSTED
- time Frame
- Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose
- title
- Part D: Cmax Assessment of Trametinib
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice