Phase I Study of Cisplatin Plus OSI-7904L in Patients With Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors

• Registration Number: NCT00116896
• Lead Sponsor: OSI Pharmaceuticals

Brief Summary

This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Status Verified: 2003-11
• Study Completion: 2004-12
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-01
• Last Update Submitted: 2009-01-16
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 18 years of age or older
• Advanced and/or metastatic solid tumor for which no effective therapy is available
• ECOG performance status 0-2
• Adequate bone marrow, hepatic and renal function

Exclusion Criteria

• Patients with active or uncontrolled infections
• Neurotoxicity >= Grade 2
• Symptomatic brain metastases which are not stable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Vanderbilt Universtiy Medical Center; 🇺🇸 Nashville, Tennessee, United States

Institute for Drug DevelopmentCancer Therapy & Research Center; 🇺🇸 San Antonio, Texas, United States