NCT00514007

Study of Continuous OSI-906 Dosing

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	OSI-906	OSI-906 administered orally

Timeline

• Start date: 2007-06-18
• Primary completion: 2012-03-19
• Completion: 2012-03-19
• First posted: 2007-08-09
• Last updated: 2024-11-20

Locations

2 sites across 2 countries: United States, United Kingdom