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

Completed · Phase 1

Conditions studied: Cancer

In brief

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

Key facts

Study ID

NCT01653470

Run by

Bristol-Myers Squibb

People needed

141

Starts

2012-10-12

Expected to finish

2017-05-08

Last updated by the study team

2020-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Usc/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Local Institution — Brussels, Belgium
• Local Institution — Edmonton, Alberta, Canada
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Ottawa, Quebec, Canada

Full record on ClinicalTrials.gov

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