The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center
Miami, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
Associates in Oncology and Hematology
Chattanooga, Tennessee, United States
Progression free survival
Time frame: 18 months
Overall response rate
Time frame: 18 months
Overall survival
Time frame: 18 months
Duration of Response
Time frame: 12 months
Safety of SPI-1620 when administered in combination with docetaxel
Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed
Time frame: 12 months
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The West Clinic
Memphis, Tennessee, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States