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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Stomach Neoplasms

Esophageal Neoplasms

Treatments

Drug: BMS-833923

Drug: Cisplatin

Drug: Capecitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00909402

CA194-004

2010-018743-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. 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.