Continuation Study of the Oral AKT Inhibitor GSK2110183

Official Title

An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumours and Hematologic Malignancies

Summary:

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.

Trial Description

Primary Outcome:

  • Adverse Events
  • laboratory values
  • vital signs

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society