A Phase Ib Ascending Multi-arm, Dose Escalation Study of BMS-906024 Combined With Several Chemotherapy Regimens in Subjects With Advanced or Metastatic Tumors
Description
Detailed Description
DLTs = dose-limiting toxicities
MTD = Maximum tolerated dose
Phase
Phase 1 - a new treatment that has not been tested, and researchers are looking for the best way to administer the treatment and how much can be given safely. Phase I trials are usually offered only to patients with advanced disease who would not be helped by other known treatments. Some patients are helped by these treatments, although in this early stage physicians don’t really know if the treatment will be effective.Inclusion and Exclusion Criteria
- Subjects with advanced or metastatic solid tumors for whom a chemotherapy regimen is considered appropriate
- Subjects with non-small cell lung cancer and triple-negative breast cancer are preferred
- Biopsy accessible tumor (may use archived tumor samples under certain circumstances)
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Measurable disease
- Uncontrolled brain metastases
- Infection
- Gastrointestinal (GI) disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
- Uncontrolled or significant cardiovascular disease
- Subjects taking medications known to increase risk of Torsades de Pointes
Sites
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California
- Usc/Norris Comprehensive Cancer Center, Los Angeles, California, 90033
- Usc/Norris Comprehensive Cancer Center, Los Angeles, California, 90033
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