Multicenter, open-label, phase 1, cohort dose escalation study to determine the Maximum Tolerated Dose (MTD) on both Once Daily (QD) and Twice Daily (BID) schedules.
Multicenter, open-label, phase 1, cohort dose escalation. The study will open with the QD schedule, with initiation of the BID schedule occurring after observation of clinically significant related toxicity ≥ grade 2 in the QD schedule. Dosing will be initiated on Day 1 with daily dosing (either QD or BID) continuing for 21 days. Once the recommended phase 2 dose has been determined for the BID schedule, 2 expansion cohorts will be opened: 1) Biomarker Expansion Cohort in patients with locally advanced or metastatic colorectal cancer and 2) Diabetic Expansion Cohort in patients with advanced solid tumors who have active Type 2 diabetes mellitus not requiring insulin or insulinotropic therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
OSI-906 administered orally
Vanderbilt Universtiy Medical Center
Nashville, Tennessee, United States
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of oral OSI-906
Time frame: 21 days
Safety profile; Pharmacokinetic (PK) profile; Pharmacodynamic relationships and preliminary antitumor activity
Time frame: 2.5 years
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