165
Participants
Start Date
September 30, 2015
Primary Completion Date
May 31, 2019
Study Completion Date
May 31, 2019
BBI503
Patients in this trial will receive BBI503 orally, daily, and continuously. The dose-level of BBI503 will be assigned according to the dose-cohort open at the time the patient enrolls into a given arm. The study-arm and combination anti-cancer agent for a given patient will be determined by the investigator. BBI503 Dose Level 1: 200 mg once daily, Dose Level 2: 300 mg once daily.
Capecitabine
Capecitabine 1000 mg/m\^2 body surface area is administered orally, twice daily, on days 1-14 of each 21 day cycle.
Doxorubicin
Doxorubicin 60 mg/m\^2 body surface area is administered intravenously once every three weeks (21-days).
Nivolumab
Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes on day 1 and day 15 of each 28 day cycle.
Pembrolizumab
Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every three weeks (21-days).
Paclitaxel
Paclitaxel 80 mg/m\^2 body surface area is administered intravenously once weekly on day 1, day 8, and day 15 of each 28 day cycle.
Sunitinib
Sunitinib 37.5 mg is administered once daily.
Indiana University Health Goshen, Goshen
Parkview Research Center, Fort Wayne
Indiana University -Ball, Indianapolis
Indiana University-SCC, Indianapolis
Louisiana State Univesity, New Orleans
US Oncology Research, Fairfax
Ottawa Hospital Research Institute, Ottawa
Princess Margaret Cancer Centre, Toronto
Sumitomo Pharma America, Inc.
INDUSTRY