An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumours and Hematologic Malignancies
GSK2110183 is an orally administered, pan-AKT kinase inhibitor that has demonstrated
nonclinical activity in hematologic as well as solid tumour cell lines and xenograft models.
In the First Time In Human (FTIH) trial, monotherapy with GSK2110183 dosed orally, once
daily has shown encouraging activity in subjects with hematologic malignancies. This
multicentre, non-randomized, open-label, treatment continuation or 'rollover' study is
designed to provide continued access to eligible subjects who have previously participated
in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research
organization working on behalf of GSK. Eligible subjects must be receiving clinical benefit
from continued treatment and have an acceptable safety profile with GSK2110183. Subjects who
have participated in a GSK2110183 combination study with an approved anti-cancer agent will
also be eligible to enroll in this rollover study. Subjects who participated in combination
studies with two investigational compounds (one being GSK2110183) will not be eligible for
this rollover study. Subjects will be enrolled by cohort based on the duration and treatment
received while in their parent study. Safety assessments (physical examinations, vital sign
measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition
scans, clinical laboratory assessments and monitoring of adverse events) will be evaluated
during this study. Disease assessment will be performed using local standard of care imaging
practices and criteria appropriate for disease type and location.
View this trial on ClinicalTrials.gov
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