Spots Global Cancer Trial Database for Study of Continuous OSI-906 Dosing

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Trial Identification

Brief Title: Study of Continuous OSI-906 Dosing

Official Title: A Phase I Dose Escalation Study of Continuous Oral OSI-906 Dosing in Patients With Advanced Solid Tumors

Study ID: NCT00514007

Conditions

Advanced Solid Tumors

Interventions

OSI-906

Study Description

Brief Summary: 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.

Detailed Description: 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.