NCT00513851

Phase 1 Study of OSI-930 in Cancer Patients

A Phase I Dose Escalation Study of Daily Oral OSI-930 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open label, phase 1, dose escalation

Detailed description

Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose on both once daily (QD) and twice daily (BID) schedules. Patients may continue to receive OSI-930 until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	OSI-930	Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity
DRUG	OSI-930	Oral OSI-930 administered twice daily at increasing doses until disease progression or unacceptable toxicity

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2007-08-09
• Last updated: 2011-09-27

Locations

3 sites across 2 countries: United States, United Kingdom