A Phase 1 interventional study of BMS-833923 and Cisplatin in Stomach Neoplasms and Esophageal Neoplasms, sponsored by Bristol-Myers Squibb. Completed at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-21.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 39 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
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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:
Exclusion Criteria:
Drug: BMS-833923 · Drug: Cisplatin · Drug: Capecitabine
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
Also known as: Platinol-AQ
Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study
Also known as: Xeloda
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)
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
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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