Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Dose Escalation Study of Continuous Oral OSI-906 Dosing in Patients With Advanced Solid Tumors
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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