A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas
Phase 1
Completed
- Conditions
- Stomach NeoplasmsEsophageal Neoplasms
- Interventions
- Registration Number
- NCT00909402
- Lead Sponsor
- Bristol-Myers Squibb
- 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 metastatic gastric, gastroesophageal or esophageal adenocarcinomas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All Subjects BMS-833923 - All Subjects Cisplatin - All Subjects Capecitabine -
- Primary Outcome Measures
Name Time Method Use National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) to establish the MTD, Dose Limiting Toxicity (DLT(s)) and safety profile of BMS-833923 administered in combination with Cisplatin and Capecitabine At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter MTD - maximum tolerated dose
- Secondary Outcome Measures
Name Time Method The pharmacokinetic parameters that will be assessed include: Tmax (Time of maximum observed plasma concentration) During cycles 1, 2 & 3 The pharmacokinetic parameters that will be assessed include: AUC(TAU) (Area under the concentration-time curve in one dosing interval) During cycles 1, 2 & 3 To evaluate the safety of single-agent BMS-833923, by assessing the evaluation of number, character and duration of adverse event (AE)/serious adverse event (SAE)s At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter Pharmacodynamic effects of BMS-833923 will be measured in tumor biopsy samples taken prior to and during single-agent and combination treatment by evaluation of protein or mRNA of biomarkers of Hedgehog (HH) pathway activation, such as GLI-1 During cycle 3 Glioma-associated oncogene (GLI)
The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration) During cycles 1, 2 & 3
Trial Locations
- Locations (4)
Local Institution
🇳🇱Amsterdam, Netherlands
City Of Hope National Medical Center
🇺🇸Duarte, California, United States
Usc/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
The University Of Texas Md Anderson Cancer Center
🇺🇸Houston, Texas, United States