NCT00259818

Dose Escalation Study of EM-1421 for the Treatment of Recurrent or Refractory Solid Tumors

An Open-Label Phase I Dose Escalation Study of Intravenous Infusion of Tetra-O-Methyl Nordihydroguaiaretic Acid (EM-1421) in Subjects With Refractory Malignant Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Erimos Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, dose escalation study of EM-1421 administered by intravenous infusion (IV) for five consecutive days every 28 days to patients with solid tumors refractory to current therapies. There have been no previous human studies of intravenous (into one's vein) EM-1421 treatment; however, lab research (research in test tubes and/or animals) suggests that EM-1421 has shown some activity against tumors in animals. This activity in animal models suggests that EM-1421 may be a useful chemotherapy for human cancer. The primary objective of this study is to determine the safety and maximum tolerated dose of EM-1421 given by intravenous infusion. The efficacy of the treatment will also be measured.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	EM-1421

Timeline

• Start date: 2005-12-01
• Completion: 2008-01-01
• First posted: 2005-12-01
• Last updated: 2008-01-24

Locations

3 sites across 1 country: United States