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Clinical Trial 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


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00435578
Study type Interventional
Source Threshold Pharmaceuticals
Contact
Status Terminated
Phase Phase 2
Start date February 2007
Completion date November 2007

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