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

Completed · Phase 1

Conditions studied: Stomach Neoplasms, Esophageal Neoplasms

In brief

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.

Key facts

Study ID

NCT00909402

Run by

Bristol-Myers Squibb

People needed

39

Starts

2009-11-01

Expected to finish

2012-11-01

Last updated by the study team

2013-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Esophageal, gastric, or gastroesophageal adenocarcinoma that has spread and cannot be treated with surgery. The diagnosis must be confirmed by a trained pathologist.
• Prior radiation therapy is allowed in certain circumstances - discuss with your doctor.
• Individuals who have had surgery may be eligible after recovering from the procedure.
• Individuals who have received chemotherapy for the treatment of their disease within the past 6 months are not eligible. Chemotherapy given more than 6 months ago is permitted.
• Individuals with spread of their cancer to the brain are permitted in certain circumstances - talk with your doctor.

You may not qualify if…

• Significant heart disease.
• Women pregnant or breastfeeding.
• Women able to bear children who are unwilling or unable to use an acceptable method to avoid pregnancy.
• Uncontrolled medical condition or active infection
• Inability to swallow pills.
• Inability to undergo a blood draw, in which a needle is used to obtain blood from a vein in your arm.
• Individuals receiving another drug not approved by the Food and Drug Administration (FDA) or similar agency in another country.
• Prisoners or individuals currently receiving treatment for a mental or physical illness as an inpatient in a hospital.
• Individuals who have experienced pancreatitis, an inflammation of the pancreas, in the past, or who have had a computed axial tomography (CT) scan showing pancreatitis.

Where it is running

• City Of Hope National Medical Center — Duarte, California, United States
• Usc/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• The University Of Texas Md Anderson Cancer Center — Houston, Texas, United States
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Villejuif, France
• Local Institution — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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