Advanced Solid Tumors Clinical Trial
Official title:
A Phase 1, Open-label Study to Investigate the Absorption, Metabolism, and Excretion of 14C-OSI-906 in Subjects With Advanced Solid Tumors With an Optional Treatment Phase
The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the Optional Treatment Phase.
This study includes two parts: Part A
Subjects will be admitted to the clinical research unit on Day -1 and remain confined to the
unit until post dosing discharge criteria are met up to a maximum of 10 days. On Day 1,
subjects will receive a single oral dose of 14C-labeled OSI-906.
Part B (optional)
Once the subject has completed part A, the subject may elect to continue participation in
Part B. Subjects will receive OSI-906 (non-radiolabeled) twice daily by mouth. Subjects will
be seen for scheduled visits every 7 days for the first 36 days and then every 21 days.
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