157
Participants
Start Date
August 31, 2014
Primary Completion Date
January 17, 2018
Study Completion Date
October 17, 2018
Nab-Paclitaxel
Nab-Paclitaxel 125 mg/m\^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
Gemcitabine
Gemcitabine 1000 mg/m\^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
Indoximod
"Indoximod will be administered in escalating doses. Initial dosing will be 600 mg BID by mouth with escalation planned to 1200 mg BID by mouth~Indoximod in the form of 200 mg capsules will be given (3, 5, and 6 capsules depending on the escalated dose). Indoximod should be taken with water by mouth one hour before breakfast and one hour prior to dinner. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity."
University of Pittsburgh Medical Center, Pittsburgh
Gibbs Cancer Center and Research Institute, Spartanburg
Greenville Health Systems, Greenville
Augusta University, Augusta
The West Clinic, Memphis
University of Kentucy, Lexington
Washington University in St. Louis, St Louis
Huntsman Cancer Center, Salt Lake City
Stanford University, Palo Alto
The Vally Hospital, Paramus
University of Vermont Medical Center, Burlington
Lead Sponsor
NewLink Genetics Corporation
INDUSTRY