Esophageal Neoplasms, Stomach Neoplasms
Conditions
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.
Interventions
DRUGBMS-833923
Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study
DRUGCisplatin
Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study
DRUGCapecitabine
Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study
Sponsors
Exelixis
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The pharmacokinetic parameters that will be assessed include: Tmax (Time of maximum observed plasma concentration) | 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 1 | Glioma-associated oncogene (GLI) mRNA - messenger Ribonucleic acid |
| The pharmacokinetic parameters that will be assessed include: Cmax (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 | — |
Countries
Canada, France, Netherlands, United States
Outcome results
None listed