NCT00435578

Safety and Efficacy Study of Glufosfamide in Patients With Recurrent Sensitive Small Cell Lung Carcinoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Threshold Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Carcinoma, Small Cell Lung

Interventions

Type	Name	Description
DRUG	Glufosfamide

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-02-15
• Last updated: 2009-04-30

Locations

3 sites across 1 country: United States