drugset / Trial / NCT01580397

Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer

NCT01580397

Phase 2 Completed 15 enrolled ImmunityBio, Inc.
NaSingle-groupOpen-labelTreatment

Summary

Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor prognosis with progression-free survival of around 13 weeks and median overall survival of approximately 20 weeks after second line chemotherapy. Recent studies suggest that albumin may be preferentially concentrated in pancreatic cancers that appear to be starved for this protein. Thus, any molecule attached to albumin would also collect inside the tumor. Based on its postulated mechanism of action, INNO-206 may improve the activity of doxorubicin without increasing its toxicity, as has been demonstrated in animal studies, and induce enhanced anti-tumor efficacy.

Timeline

Start
2012-05-16
Primary completion
2013-05-13
Completion
2013-07-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Aldoxorubicin Small molecule 350 mg/m2 Intravenous