TriangleNCT01072175 · OUTCOME
Part B (Analyte=GSK1120212): AUC (0-tau) Assessment of Trametinib in Combination With Dabrafenib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*hr/mL
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 15 and Day 21
What was measured
AUC (0-tau) is defined as area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration. AUC (0-tau) was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.
Analysis population: PK Population. Only those participants who were available at the indicated time points were analyzed.
Groups in this outcome
Part B: Dabrafenib 75 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
| Group | Source count |
|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 6 |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 8 |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 12 |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 8 |
Reported measurements
Day 15
| Group | Source count |
|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 6 |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 8 |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 12 |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 169 | Not reported | 113 | 252 | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 147 | Not reported | 101 | 212 | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 217 | Not reported | 139 | 338 | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 394 | Not reported | 229 | 679 | Not reported |
Day 21
| Group | Source count |
|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 8 |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 12 |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 169 | Not reported | 146 | 194 | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 269 | Not reported | 238 | 304 | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 351 | Not reported | 284 | 432 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 113
- upper Limit
- 252
- value
- 169
- group Id
- OG001
- lower Limit
- 101
- upper Limit
- 212
- value
- 147
- group Id
- OG002
- lower Limit
- 139
- upper Limit
- 338
- value
- 217
- group Id
- OG003
- lower Limit
- 229
- upper Limit
- 679
- value
- 394
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 8
- units
- Participants
- title
- Day 15
- categories
- measurements
- group Id
- OG001
- lower Limit
- 146
- upper Limit
- 194
- value
- 169
- group Id
- OG002
- lower Limit
- 238
- upper Limit
- 304
- value
- 269
- group Id
- OG003
- lower Limit
- 284
- upper Limit
- 432
- value
- 351
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 8
- units
- Participants
- title
- Day 21
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 8
- units
- Participants
- description
- AUC (0-tau) is defined as area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration. AUC (0-tau) was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
- id
- OG000
- title
- Part B: Dabrafenib 75 mg + Trametinib 1 mg
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
- id
- OG001
- title
- Part B: Dabrafenib 150 mg + Trametinib 1 mg
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
- id
- OG002
- title
- Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
- description
- Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
- id
- OG003
- title
- Part B: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Population. Only those participants who were available at the indicated time points were analyzed.
- reporting Status
- POSTED
- time Frame
- Day 15 and Day 21
- title
- Part B (Analyte=GSK1120212): AUC (0-tau) Assessment of Trametinib in Combination With Dabrafenib
- type
- SECONDARY
- unit Of Measure
- ng*hr/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice