This study is a first time in human, Phase I, open-label study to determine recommended doses and schedules, based on maximum tolerated doses and biologically active doses, for the AKT inhibitor GSK690693.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Durham, North Carolina, United States
To determine the maximum tolerated dose of GSK690693 given weekly or twice weekly over 1 - 4 hours.
Time frame: given weekly or twice weekly over 1 - 4 hours
Blood pressure and heart rate every 8 hours.
Time frame: every 8 hours.
12-lead ECGs will be conducted at 4, 8, 10, 12, 14, 24hrs
Time frame: 4, 8, 10, 12, 14, 24hrs
Pharmacokinetics and Pharmacodynamics via blood draws before, during, and after the infusion.
Time frame: draws before, during, and after the infusion
Urinalysis samples while the patient is hospitalized
Time frame: while the patient is hospitalized
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