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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Stomach Neoplasms Esophageal Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All Subjects

Group Type EXPERIMENTAL

BMS-833923

Intervention Type DRUG

Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study

Cisplatin

Intervention Type DRUG

Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study

Capecitabine

Intervention Type DRUG

Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study

Interventions

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BMS-833923

Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study

Intervention Type DRUG

Cisplatin

Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study

Intervention Type DRUG

Capecitabine

Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study

Intervention Type DRUG

Other Intervention Names

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Platinol-AQ Xeloda

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No