Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441467
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2007-02-27
Brief Title:
Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
Sponsor:
Eleison Pharmaceuticals LLC
Organization:
Eleison Pharmaceuticals LLC
Study Overview
Official Title:
An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Primary Objective
1 To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate
Secondary Objectives
1 To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response progression-free survival and overall survival
2 To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma
Exploratory Objectives
1 To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas as determined by FDG-PET
2 To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins
1 To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate
Secondary Objectives
1 To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response progression-free survival and overall survival
2 To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma
Exploratory Objectives
1 To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas as determined by FDG-PET
2 To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins
Detailed Description:
None
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