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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018743-33 | EudraCT Number |
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| Name | Class |
|---|---|
| Exelixis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-833923 | Drug | Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Of Hope National Medical Center | Duarte | California | 91010-3012 | United States | ||
| Usc/Norris Comprehensive Cancer Center |
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| Cisplatin | Drug | Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study |
|
|
| Capecitabine | Drug | Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study |
|
|
Glioma-associated oncogene (GLI) mRNA - messenger Ribonucleic acid |
| 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) | 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) | During cycle 3 |
| 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: 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 |
| Los Angeles |
| California |
| 90033 |
| United States |
| The University Of Texas Md Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution | Villejuif | 94805 | France |
| Local Institution | Amsterdam | 1105 AZ | Netherlands |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
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| ID | Term |
|---|---|
| C583051 | BMS-833923 |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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