NCT00099294

Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer

A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: Threshold Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.

Detailed description

TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells. Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care. Comparison: Glufosfamide versus best supportive care.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Glufosfamide

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2004-12-10
• Last updated: 2009-04-30

Locations

111 sites across 11 countries: United States, Argentina, Brazil, Bulgaria, Czechia, Hungary, India, Mexico, Romania, Russia, Ukraine