Phase I/II Evaluation of Safety and Efficacy of Rexin-G for Recurrent or Metastatic Pancreatic Cancer
The clinical trial is a safety and efficacy study using escalating doses of Rexin-G that
incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an
adaptive trial design. Each treatment cycle will be six weeks: four weeks of treatment and
two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat
cycles after the safety data and objective tumor response/s are recorded. Continued Rexin-G
treatment will enable the targeted genetic medicine to catch up with tumor growth, halt
disease progression, and reduce tumor burden. The treatment strategy is to achieve tumor
control as quickly as safely possible. The goal of the adaptive trial design is to confirm
the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that
would document the significant clinical benefits required to support a Phase II/III pivotal
trial.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic, and metabolic profiles.
24
Yes
Sant P Chawla, M.D.
Principal Investigator
Epeius Clinical Research Unit/Sarcoma Oncology Center
United States: Food and Drug Administration
C07-105
NCT00504998
July 2007
June 2011
Name | Location |
---|---|
Sarcoma Oncology Center | Santa Monica, California 90403 |
Epeius Clinical Research Unit | San Marino, California 91108 |
Bruckner Oncology | New York, New York 10003 |