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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Exelixis
• Treatments: Capecitabine; Cisplatin

Criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email[email protected]. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.