NCT00207103

MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.

Conditions

• Tumors
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Brivanib	Tablets, Oral, 180 mg, once daily, until disease progression
DRUG	Brivanib	Tablets, Oral, 320 mg, once daily, until disease progression
DRUG	Brivanib	Tablets, Oral, 600 mg, once daily, until disease progression
DRUG	Brivanib	Tablets, Oral, 800 mg, once daily, until disease progression
DRUG	Brivanib	Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
DRUG	Brivanab	Tablets, Oral, 1000 mg, once daily, until disease progression

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-10-01
• Completion: 2008-09-01
• First posted: 2005-09-21
• Last updated: 2008-11-04

Locations

8 sites across 4 countries: United States, Canada, Italy, United Kingdom