NCT00102752

Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer

A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (planned)
• Sponsor: Threshold Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.

Detailed description

This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer. Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.

Conditions

• Neoplasms
• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	Glufosfamide
DRUG	Gemcitabine

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2005-02-02
• Last updated: 2009-04-30

Locations

9 sites across 2 countries: United States, Brazil