NCT00909402

A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas

Phase 1b Multiple Ascending Dose Study of BMS-833923 (XL139) Administered in Combination With Cisplatin and Capecitabine as First-Line Therapy in Patients With Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (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 Cisplatin and Capecitabine as first-line therapy in subjects with inoperable metastatic gastric, gastroesophageal or esophageal adenocarcinomas.

Conditions

• Stomach Neoplasms
• Esophageal Neoplasms

Interventions

Type	Name	Description
DRUG	BMS-833923	Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study
DRUG	Cisplatin	Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study
DRUG	Capecitabine	Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2009-05-28
• Last updated: 2013-06-21

Locations

6 sites across 4 countries: United States, Canada, France, Netherlands