Status:
COMPLETED
A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Exelixis
Conditions:
Stomach Neoplasms
Esophageal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 m...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00909402
Start Date
November 1 2009
End Date
November 1 2012
Last Update
June 21 2013
Active Locations (6)
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1
City Of Hope National Medical Center
Duarte, California, United States, 91010-3012
2
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030-4009
4
Local Institution
Toronto, Ontario, Canada, M5G 2M9