Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435578
Status:
TERMINATED
Last Update Posted:
2009-04-30
First Post:
2007-02-13
Brief Title:
Safety and Efficacy Study of Glufosfamide in Patients With Recurrent Sensitive Small Cell Lung Carcinoma
Sponsor:
Threshold Pharmaceuticals
Organization:
Threshold Pharmaceuticals
Study Overview
Official Title:
An Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of Glufosfamide in the Treatment of Patients With Recurrent Sensitive Small Cell Lung Carcinoma
Status:
TERMINATED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this study are
1 To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer SCLC as measured by objective response rate
2 To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive SCLC
The secondary objectives are
1 To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive SCLC as measured by duration of response progression-free survival and overall survival
2 To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard IPM
The exploratory objectives of this trial are
1 To evaluate the effect of glufosfamide on lung cancer symptoms
2 To evaluate the role of tumor cell glucose transporter expression on the efficacy of glufosfamide
1 To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer SCLC as measured by objective response rate
2 To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive SCLC
The secondary objectives are
1 To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive SCLC as measured by duration of response progression-free survival and overall survival
2 To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard IPM
The exploratory objectives of this trial are
1 To evaluate the effect of glufosfamide on lung cancer symptoms
2 To evaluate the role of tumor cell glucose transporter expression on the efficacy of glufosfamide
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