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A Phase Ib/II Study of the Microenvironment Modifier L-DOS47 Plus Doxorubicin for the Treatment of Patients with Previously Treated Advanced Pancreatic Cancer

Protocol No
HELIX-LDOS006
Principal Investigator
Ben George
Phase
I/II
Summary
The study is made up of a screening period up to 4 weeks (28 days) long, followed by 4-week (28-day) treatment periods, which are called cycles, and a 30-day follow-up period. The maximum number of cycles you can receive is six (6). During each treatment cycle, the study drug L-DOS47 will be given weekly on Days 1, 8, 15 and 22. Doxorubicin, a chemotherapeutic agent, will be given weekly on Days 2, 9, 16 and 23, the day following each of the L-DOS47 infusions. Both L-DOS47 and doxorubicin will be given by slow injection of drug through a vein into the body (intravenous infusion). On days that you receive L-DOS47, it will be administered over a 30-minute period. On days that you receive doxorubicin, it will be administered as per local standard practice.
Description
The purpose of this study is to evaluate in patients with metastatic pancreatic cancer, the overall safety, tolerability, and preliminary anti-tumor activity of adding an investigational drug, L DOS47, to doxorubicin, a type of chemotherapy drug
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL