Overview

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.