Solid Tumours Clinical Trial
Official title:
A Phase I Open-Label, Dose-Escalation Study of the Phosphoinositide 3-Kinase Inhibitor GSK2126458 in Subjects With Solid Tumors or Lymphoma
P3K112826 is a Phase I, first-time-in-human dose escalation study in subjects with refractory malignancy. The primary objective of this study is to determine the recommended Phase II dose of GSK2126458 based on safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary evidence of clinical activity. Secondary objectives are to characterize the pharmacokinetics of GSK2126458; and to explore relationships between GSK2126458 pharmacokinetics, pharmacodynamics, response prediction biomarkers and clinical endpoints.
This study is a Phase I, first-time-in-human dose escalation study in subjects with
refractory solid tumors or lymphoma. The primary objective of this study is to determine the
recommended Phase II dose of GSK2126458 based on safety and tolerability, pharmacokinetics,
pharmacodynamics and preliminary evidence of clinical activity. Secondary objectives are to
characterize the pharmacokinetics of GSK2126458; and to explore relationships between
GSK2126458 pharmacokinetics, pharmacodynamics, response prediction biomarkers and clinical
endpoints.
Subjects with solid tumors or lymphoma will initially receive oral GSK2126458 daily for 28
consecutive days in each 28 day cycle. Subjects may be dosed once or twice a day or may be
dosed on an intermittent schedule depending on the safety, pharmacokinetic and
pharmacodynamic results that become available as the study progresses. The starting dose
will be 0.1 mg once a day. Expansion of some cohorts will be conducted to test tumor
pharmacodynamics, further explore the toxicity profile and to look for preliminary evidence
of activity in subjects with tumors with PIK3CA mutations. The recommended Phase II dose
will be the lowest dose explored (at or below MTD) that maintains biologic activity with an
acceptable tolerability profile.
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