Phase I/II Evaluation of Safety and Efficacy of Pathotropic Nanoparticles Bearing a Dominant Negative Cyclin G1 Construct (Rexin-G) as Intervention for Recurrent or Metastatic Breast Cancer
The clinical trial 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 nanomedicine 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
registration protocol for breast cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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.
Sant P Chawla, M.D.
Epeius Clinical Research Unit/Sarcoma Oncology Center
United States: Food and Drug Administration
|Sarcoma Oncology Center||Santa Monica, California 90403|
|Epeius Clinical Research Unit||San Marino, California 91108|
|Bruckner Oncology||New York, New York 10003|