NCT00927875

A Study of BMS-833923 With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer

A Phase 1b Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-833923 (XL139) in Combination With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with carboplatin and etoposide followed by BMS-833923 alone in subjects with extensive-stage Small Cell Lung Cancer (SCLC).

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	BMS-833923	Capsule, Oral, starting dose 30 mg, once daily, continuous
DRUG	Carboplatin	Vial, Intravenous (IV), dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles
DRUG	Etoposide	Vial, Intravenous (IV), 100 mg/m²/dose, days 1, 2, \& 3 of each 21 day cycle, 3 days per cycle for up to 4 cycles

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2009-06-25
• Last updated: 2013-06-03

Locations

6 sites across 5 countries: United States, Australia, Canada, France, Ireland