Safety and Efficacy Study Using Rexin-G for Breast Cancer
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 recurrent or metastatic breast cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic and metabolic profiles. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- To identify an objective tumor response to Rexin-G [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Escalating doses of Rexin-G will be given two or three times a week for four weeks, with a 2 week rest period
Three patients will receive Rexin-G at Dose Level I. If 1 of 3 patients at Dose Level I develops a grade 3 or 4 adverse event (CTCAE Version 3.0) which appears to be related or possibly related to Rexin-G, then 3 additional patients will be enrolled at the same dose level. If at least 2 of the first 3, or 3 of 6 patients at Dose Level I develop a grade 3 to 4 adverse event which appears to be related or possibly related to Rexin-G, accrual into the study will be held.
At any dose level, up to six patients may be enrolled if there is evidence of biological activity in the first three patients. Dose escalation may stop if there is impressive evidence of biological activity. An amendment would be submitted to allow further expansion of dose level based on impressive biological activity.
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.
|United States, California|
|Epeius Clinical Research Unit|
|San Marino, California, United States, 91108|
|Sarcoma Oncology Center|
|Santa Monica, California, United States, 90403|
|United States, New York|
|New York, New York, United States, 10003|
|Principal Investigator:||Sant P Chawla, M.D.||Epeius Clinical Research Unit/Sarcoma Oncology Center|
|Principal Investigator:||Howard W Bruckner, M.D.||Bruckner Oncology|