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

NCT00435578 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-04-30

No results posted yet for this study

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

DRUG

Glufosfamide

Sponsors & Collaborators

  • Threshold Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gerold Bepler, MD, PhD · H. Lee Moffitt Cancer Center and Research Institute

  • John C Ruckdeschel, MD · Barbara Ann Karmanos Cancer Institute

  • Peter D Eisenberg, MD · California Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00435578 on ClinicalTrials.gov