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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study
Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study
Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study
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
Local Institution
Toronto, Ontario, Canada
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
MTD - maximum tolerated dose
Time frame: At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter
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
Time frame: 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
Glioma-associated oncogene (GLI) mRNA - messenger Ribonucleic acid
Time frame: During cycle 1
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
Glioma-associated oncogene (GLI)
Time frame: During cycle 2
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
Glioma-associated oncogene (GLI)
Time frame: During cycle 3
The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration)
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Local Institution
Villejuif, France
Local Institution
Amsterdam, Netherlands
Time frame: During cycles 1, 2 & 3
The pharmacokinetic parameters that will be assessed include: Tmax (Time of maximum observed plasma concentration)
Time frame: 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)
Time frame: During cycles 1, 2 & 3