This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600E/K mutation positive advanced solid tumors (Phase I part) and BRAF V600E/K mutation positive cutaneous melanoma (Phase II part).
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
Timeframe: From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 year)
Phase I: Number of Participants With a Dose-limiting Toxicity (DLT)
Timeframe: From the start of study treatment until 21 days
Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs)
Timeframe: From Baseline until the post-treatment Visit (average of 1.38 year)
Phase I: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters
Timeframe: From Baseline until the post-treatment Visit (average of 1.38 year)
Phase I: Number of Participants With the Indicated Urinalysis Parameters
Timeframe: From Baseline until the post-treatment Visit (average of 1.38 year)
Phase I: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance (Pef) Status
Timeframe: From Baseline until the post-treatment Visit (average of 1.38 year)
Phase I: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3
Timeframe: From Baseline until the post-treatment Visit (average of 1.38 year)
Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate
Timeframe: From Baseline until the post-treatment Visit (average of 1.38 year)
Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature
Timeframe: From Baseline until the post-treatment Visit (average of 1.38 years)
Phase I: Change From Baseline in Oxygen Saturation (SpO2) Measured Via Pulse Oxymetry at the Indicated Time Points
Timeframe: From Baseline until the post-treatment Visit (average of 1.38 year)
Phase I: Change From Baseline in Weight at the Indicated Time Points
Timeframe: From Baseline until the post-treatment Visit ( average of 1.38 year)
Phase I: Number of Participants With the Indicated Electrocardiogram (ECG) Findings at the Indicated Time Points
Timeframe: From Baseline until the post-treatment Visit (average of 1.38 year)
Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram (ECHO)
Timeframe: From Baseline until the post-treatment Visit (average of 1.38 years)
Phase II: Number of Participant With Confirmed Overall Response
Timeframe: Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)