Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline
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
Clinical Chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. 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
Albumin
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
1
Part B: Dabrafenib 150 mg + Trametinib 2 mg
3
Increase to Grade 3
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
1
Not reported
Not reported
Not reported
Not reported
Part B: Dabrafenib 150 mg + Trametinib 2 mg
3
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Alkaline Phosphatase
Analysis denominator · Participants
Group
Source count
Part B: Dabrafenib 75 mg + Trametinib 1 mg
1
Part B: Dabrafenib 150 mg + Trametinib 1 mg
2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
1
Part B: Dabrafenib 150 mg + Trametinib 2 mg
10
Increase to Grade 3
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
10
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Alanine Amino Transferase
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
1
Part B: Dabrafenib 150 mg + Trametinib 2 mg
2
Increase to Grade 3
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
1
Not reported
Not reported
Not reported
Not reported
Part B: Dabrafenib 150 mg + Trametinib 2 mg
2
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Amylase
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
Increase to Grade 3
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 Grade 4
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
Aspartate Amino Transferase
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
1
Part B: Dabrafenib 150 mg + Trametinib 2 mg
5
Increase to Grade 3
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
1
Not reported
Not reported
Not reported
Not reported
Part B: Dabrafenib 150 mg + Trametinib 2 mg
5
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Total 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
2
Increase to Grade 3
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
2
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Calcium (Hypercalcemia)
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
Increase to Grade 3
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 Grade 4
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
Calcium (Hypocalcemia)
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
1
Part B: Dabrafenib 150 mg + Trametinib 2 mg
2
Increase to Grade 3
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
1
Not reported
Not reported
Not reported
Not reported
Part B: Dabrafenib 150 mg + Trametinib 2 mg
1
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
1
Not reported
Not reported
Not reported
Not reported
Creatine Kinase
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
Increase to Grade 3
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 Grade 4
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
Creatinine
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
1
Part B: Dabrafenib 150 mg + Trametinib 2 mg
0
Increase to Grade 3
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 Grade 4
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
1
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
Gamma Glutamyl Transferase
Analysis denominator · Participants
Group
Source count
Part B: Dabrafenib 75 mg + Trametinib 1 mg
1
Part B: Dabrafenib 150 mg + Trametinib 1 mg
0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
3
Part B: Dabrafenib 150 mg + Trametinib 2 mg
13
Increase to Grade 3
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
0
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
13
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Glucose (Hyperglycemia)
Analysis denominator · Participants
Group
Source count
Part B: Dabrafenib 75 mg + Trametinib 1 mg
0
Part B: Dabrafenib 150 mg + Trametinib 1 mg
2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
2
Part B: Dabrafenib 150 mg + Trametinib 2 mg
5
Increase to Grade 3
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
2
Not reported
Not reported
Not reported
Not reported
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
2
Not reported
Not reported
Not reported
Not reported
Part B: Dabrafenib 150 mg + Trametinib 2 mg
5
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Glucose (Hypoglycemia)
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
1
Increase to Grade 3
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
1
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Potassium (Hyperkalemia)
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
1
Increase to Grade 3
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
1
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Potassium (Hypokalemia)
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
1
Part B: Dabrafenib 150 mg + Trametinib 2 mg
4
Increase to Grade 3
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
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 Grade 4
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
Lipase
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
Increase to Grade 3
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 Grade 4
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
Magnesium (Hypermagnesemia)
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
Increase to Grade 3
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 Grade 4
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
Magnesium (Hypomagnesemia)
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
Increase to Grade 3
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 Grade 4
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
Sodium (Hypernatremia)
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
Increase to Grade 3
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 Grade 4
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
Sodium (Hyponatremia)
Analysis denominator · Participants
Group
Source count
Part B: Dabrafenib 75 mg + Trametinib 1 mg
0
Part B: Dabrafenib 150 mg + Trametinib 1 mg
2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
7
Part B: Dabrafenib 150 mg + Trametinib 2 mg
12
Increase to Grade 3
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
2
Not reported
Not reported
Not reported
Not reported
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
7
Not reported
Not reported
Not reported
Not reported
Part B: Dabrafenib 150 mg + Trametinib 2 mg
12
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Blood pH
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
Increase to Grade 3
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 Grade 4
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
Phosphorus inorganic
Analysis denominator · Participants
Group
Source count
Part B: Dabrafenib 75 mg + Trametinib 1 mg
0
Part B: Dabrafenib 150 mg + Trametinib 1 mg
2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
6
Part B: Dabrafenib 150 mg + Trametinib 2 mg
4
Increase to Grade 3
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
2
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
4
Not reported
Not reported
Not reported
Not reported
Increase to Grade 4
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
Uric acid
Analysis denominator · Participants
Group
Source count
Part B: Dabrafenib 75 mg + Trametinib 1 mg
1
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
1
Increase to Grade 3
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 Grade 4
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
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
1
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
1
group Id
OG003
value
3
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 4
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
3
units
Participants
title
Albumin
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
10
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 4
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
10
units
Participants
title
Alkaline Phosphatase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
2
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 4
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
2
units
Participants
title
Alanine Amino Transferase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 4
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
Amylase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
5
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 4
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
5
units
Participants
title
Aspartate Amino Transferase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 4
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
units
Participants
title
Total Bilirubin
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 4
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
Calcium (Hypercalcemia)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
title
Increase to Grade 4
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
2
units
Participants
title
Calcium (Hypocalcemia)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 4
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
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Increase to Grade 4
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
units
Participants
title
Creatinine
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
13
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 4
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
13
units
Participants
title
Gamma Glutamyl Transferase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
5
title
Increase to Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Increase to Grade 4
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
5
units
Participants
title
Glucose (Hyperglycemia)
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
Clinical Chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. 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 Toxicity Grade Change From Baseline
Triangle