NCT01584648 · OUTCOME
Trametinib Pharmacokinetic Concentrations
A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma · Source last updated 2021-02-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Nanogram per Milliliter (ng/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Week 8 (0, 1-3, 4-6 hours post dose), Weeks 16 and 24 (0 hour pre-dose)
What was measured
Blood samples were collected for Pharmacokinetic (PK) analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24. Only descriptive analysis performed.
Analysis population: Pharmacokinetic (PK) Population: all participants included in the safety population for whom a PK sample was obtained and analyzed. Only participants with data available at the specified time points were analyzed.
Groups in this outcome
Dabrafenib + Trametinib
Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
Dabrafenib + Placebo
Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Dabrafenib + Trametinib | 203 |
|---|
| Dabrafenib + Placebo | 194 |
|---|
Reported measurements
Week 8, pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dabrafenib + Trametinib | 176 |
|---|
| Dabrafenib + Placebo | 170 |
|---|
Values in Nanogram per Milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dabrafenib + Trametinib | 9.9209 | 3.86587 | Not reported | Not reported | Not reported |
|---|
| Dabrafenib + Placebo | 0.0000 | 0.00000 | Not reported | Not reported | Not reported |
|---|
Week 8, 1-3 hours
Analysis denominator · Participants
| Group | Source count |
|---|
| Dabrafenib + Trametinib | 176 |
|---|
| Dabrafenib + Placebo | 176 |
|---|
Values in Nanogram per Milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dabrafenib + Trametinib | 19.0382 | 6.86542 | Not reported | Not reported | Not reported |
|---|
| Dabrafenib + Placebo | 0.0261 | 0.34598 | Not reported | Not reported | Not reported |
|---|
Week 8, 4-6 hours
Analysis denominator · Participants
| Group | Source count |
|---|
| Dabrafenib + Trametinib | 174 |
|---|
| Dabrafenib + Placebo | 171 |
|---|
Values in Nanogram per Milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dabrafenib + Trametinib | 16.7496 | 5.64363 | Not reported | Not reported | Not reported |
|---|
| Dabrafenib + Placebo | 0.0000 | 0.00000 | Not reported | Not reported | Not reported |
|---|
Week 16 pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dabrafenib + Trametinib | 179 |
|---|
| Dabrafenib + Placebo | 162 |
|---|
Values in Nanogram per Milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dabrafenib + Trametinib | 11.0385 | 4.79185 | Not reported | Not reported | Not reported |
|---|
| Dabrafenib + Placebo | 0.0039 | 0.03548 | Not reported | Not reported | Not reported |
|---|
Week 24 pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dabrafenib + Trametinib | 157 |
|---|
| Dabrafenib + Placebo | 130 |
|---|
Values in Nanogram per Milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dabrafenib + Trametinib | 11.5167 | 5.19171 | Not reported | Not reported | Not reported |
|---|
| Dabrafenib + Placebo | 0.0548 | 0.62447 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.86587
- value
- 9.9209
- group Id
- OG001
- spread
- 0.00000
- value
- 0.0000
- denoms
- counts
- group Id
- OG000
- value
- 176
- group Id
- OG001
- value
- 170
- units
- Participants
- title
- Week 8, pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 6.86542
- value
- 19.0382
- group Id
- OG001
- spread
- 0.34598
- value
- 0.0261
- denoms
- counts
- group Id
- OG000
- value
- 176
- group Id
- OG001
- value
- 176
- units
- Participants
- title
- Week 8, 1-3 hours
- categories
- measurements
- group Id
- OG000
- spread
- 5.64363
- value
- 16.7496
- group Id
- OG001
- spread
- 0.00000
- value
- 0.0000
- denoms
- counts
- group Id
- OG000
- value
- 174
- group Id
- OG001
- value
- 171
- units
- Participants
- title
- Week 8, 4-6 hours
- categories
- measurements
- group Id
- OG000
- spread
- 4.79185
- value
- 11.0385
- group Id
- OG001
- spread
- 0.03548
- value
- 0.0039
- denoms
- counts
- group Id
- OG000
- value
- 179
- group Id
- OG001
- value
- 162
- units
- Participants
- title
- Week 16 pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 5.19171
- value
- 11.5167
- group Id
- OG001
- spread
- 0.62447
- value
- 0.0548
- denoms
- counts
- group Id
- OG000
- value
- 157
- group Id
- OG001
- value
- 130
- units
- Participants
- title
- Week 24 pre-dose
- denoms
- counts
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 194
- units
- Participants
- description
- Blood samples were collected for Pharmacokinetic (PK) analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24. Only descriptive analysis performed.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Dabrafenib + Trametinib
- description
- Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
- id
- OG001
- title
- Dabrafenib + Placebo
- param Type
- MEAN
- population Description
- Pharmacokinetic (PK) Population: all participants included in the safety population for whom a PK sample was obtained and analyzed. Only participants with data available at the specified time points were analyzed.
- reporting Status
- POSTED
- time Frame
- Week 8 (0, 1-3, 4-6 hours post dose), Weeks 16 and 24 (0 hour pre-dose)
- title
- Trametinib Pharmacokinetic Concentrations
- type
- SECONDARY
- unit Of Measure
- Nanogram per Milliliter (ng/mL)
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