NCT00603356

Phase I Study of OSI-930 and Erlotinib in Cancer Tumors

A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) 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

This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.

Detailed description

Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib. Patients may continue to receive OSI-930 and Erlotinib 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 and erlotinib	OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-04-01
• Completion: 2010-07-01
• First posted: 2008-01-29
• Last updated: 2011-09-27

Locations

2 sites across 2 countries: United States, United Kingdom