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).
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)