Evaluation of Safety and Efficacy of Rexin-G as Intervention for Recurrent or Metastatic Sarcoma
The Phase I/II 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.
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
12 months
Yes
Sant P Chawla, M.D.
Principal Investigator
Epeius Clinical Research Unit/Sarcoma Oncology Center
United States: Food and Drug Administration
C07-103
NCT00505713
July 2007
June 2011
Name | Location |
---|---|
Sarcoma Oncology Center | Santa Monica, California 90403 |
Epeius Clinical Research Unit | San Marino, California 91108 |