NCT01072175 · OUTCOME
Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)
What was measured
For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
Analysis population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 6 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 23 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 27 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 94 |
|---|
Reported measurements
Direct Bilirubin
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Indirect Bilirubin
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Creatine Kinase MB mass
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Chloride
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 15 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 18 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 55 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 39 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
Carbon dioxide content/Bicarbonate
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 4 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 11 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 17 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 41 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
Creatinine clearance
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 4 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 9 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 15 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 27 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Lactate dehydrogenase
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 5 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 11 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 12 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 39 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
Total protein
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 3 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 12 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 11 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 37 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Troponin I
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Trponin T
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Urea/BUN
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 3 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 14 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 19 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 47 |
|---|
Decrease to Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Direct Bilirubin
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Indirect Bilirubin
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Creatine Kinase MB mass
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 39
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 16
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 55
- units
- Participants
- title
- Chloride
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 16
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 25
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 41
- units
- Participants
- title
- Carbon dioxide content/Bicarbonate
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 19
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 8
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 27
- units
- Participants
- title
- Creatinine clearance
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 35
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 39
- units
- Participants
- title
- Lactate dehydrogenase
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 30
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 7
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 37
- units
- Participants
- title
- Total protein
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Troponin I
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Trponin T
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 17
- title
- Decrease to Low
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 30
- title
- Increase to High
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 47
- units
- Participants
- title
- Urea/BUN
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 94
- units
- Participants
- description
- For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)
- title
- Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
Triangle