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.
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
Phase
I/II
Summary
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
Categories
ClinicalTrials.gov