Carcinoma, Small Cell Lung Clinical Trial
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
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
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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