Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors
Status: | Completed |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/21/2017 |
Start Date: | October 12, 2012 |
End Date: | May 3, 2017 |
A Phase Ib Ascending Multi-arm, Dose Escalation Study of BMS-906024 Combined With Several Chemotherapy Regimens in Subjects With Advanced or Metastatic Tumors
The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in
combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus
Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic
solid tumors
combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus
Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic
solid tumors
DLTs = dose-limiting toxicities
MTD = Maximum tolerated dose
MTD = Maximum tolerated dose
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.
Inclusion 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
Exclusion Criteria:
- 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
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