Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505713
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2007-07-19
Brief Title:
Safety and Efficacy Study Using Rexin-G for Sarcoma
Sponsor:
Epeius Biotechnologies
Organization:
Epeius Biotechnologies
Study Overview
Official Title:
Evaluation of Safety and Efficacy of Rexin-G as Intervention for Recurrent or Metastatic Sarcoma
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rexin-G is a tumor-targeted pathotropic or disease-seeking nanoparticle that when injected intravenously seeks out and accumulates in cancerous lesions thus enhancing local drug concentration within tumors 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
Detailed Description:
The Phase III 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 responses 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None