NCT00420186

A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin

A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With Paclitaxel and Carboplatin for Patients With Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical research is to assess the safety and tolerability of BMS-690514 when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with Paclitaxel and carboplatin

Conditions

• Cancer (Solid Tumors)

Interventions

Type	Name	Description
DRUG	BMS-690514	Tablets / IV, Oral / IV, 100 to 300 mg / Paclitaxel (200 mg/m2) / Carboplatin dose (mg) = Target AUC (6) x (GFR + 25), Once daily Days 4-19, up to 24 mos

Timeline

• Start date: 2007-10-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2007-01-09
• Last updated: 2016-09-30

Locations

4 sites across 3 countries: United States, Canada, United Kingdom