NCT00756912

A Study of Eritoran (E5564) Administered IV Over 14 Days Prior to and During Bone Marrow Engraftment in BMT Patients Who Have Received Myeloablative Conditioning Treatment and Are Receiving Bone Marrow or Stem Cells From Matched Related Donors

A Phase I, Open-Label, Dose Escalation Study of Eritoran (E5564) Administered IV Over 14 Days Prior to and During Bone Marrow Engraftment in BMT Patients Who Have Received Myeloablative Conditioning Treatment and Are Receiving Bone Marrow or Stem Cells From Matched Related Donors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a study designed to assess the safety of administration of up to 3 dose levels of eritoran in subjects undergoing or scheduled to undergo allogeneic bone marrow transplant (BMT). An allogeneic BMT is the transplantation of blood stem cells taken from the bone marrow or blood of another person.

Detailed description

Please note: in the original protocol, the study phase is listed as "Phase Ib", although the Official Title reads "Phase I".

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	E5564	Three dose levels of Eritoran IV over 14 days for a total of 32, 96, and 224 mg over 14 days.

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-11-01
• First posted: 2008-09-22
• Last updated: 2014-07-11

Locations

1 site across 1 country: United States