Study Title
A study to evaluate the effect of repeat oral dosing of GSK2118436 on cardiac repolarization in subjects with V600 BRAF mutation-positive tumors
Malignancy
z- melanoma, colorectal cancer, colon cancer, rectal cancer, lung, brain, pancreas, gastric, stomach, head and neck, prostate, bladder, sarcoma, brain
Key Eligibility Criteria Details
Confirmed diagnosis of V600 BRAF-mutation positive tumor
ECOG PS 0-1
No significant ECG abnormalities
No recent CHF, MI, unstable angina, or symptomatic peripheral vascular disease
LVEF >50%
No anti-cancer therapy within 28 days
No known HIV, HBV, HCV
No symptomatic brain mets or >1cm
Objective
Primary- Safety and tolerability by PE, VS, ECG readings, lab assessments; Secondary- Plasma concentration, PK (AUC, Cmax), change in QTc