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ADVANCED SOLID TUMORS; Phase 1; BRAF mutation; "113773"

A study to evaluate the effect of repeat oral dosing of GSK2118436 on cardiac repolarization in subjects with V600 BRAF mutation-positive tumors

Title
GSK 113773
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
Site Link
Malignancy
z- melanoma, colorectal cancer, colon cancer, rectal cancer, lung, brain, pancreas, gastric, stomach, head and neck, prostate, bladder, sarcoma, brain
Stage
Disease Setting
Metastatic/palliative
Line Of Therapy
Any
Investigational Agent
Dabrafenib
Drug Class
BRAF inhibitor
PI
Jason Chandler, MD
Sponsor
GlaxoSmithKline
Phase
Status
Key Eligibility Criteria
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
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
BRAF mutation
Dosing Frequency
_
Control Agents
Part 1- N/A, Part 2- placebo
Study Protocol
Randomized
Yes
X