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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00756912 |
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.
Condition | Intervention | Phase |
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Leukemia |
Drug: E5564 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 30 |
Study Start Date: | September 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: E5564
Three dose levels of Eritoran IV over 14 days for a total of 32, 96, and 224 mg over 14 days.
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Please note: in the original protocol, the study phase is listed as "Phase Ib", although the Official Title reads "Phase I".
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet all of the inclusion criteria outlined below in order to be eligible to participate in this study:
Subjects using either busulfan or total body irradiation (TBI) containing regimens for BMT for the treatment of malignant and nonmalignant diseases.
For example:
Leukemia patients with:
OR
Subjects with non-Hodgkin's lymphoma who are in complete remission as determined by physical exam, CT and PET scans, and are otherwise considered candidates for allogeneic BMT as judged by the treating institution
Exclusion Criteria:
Any of the following laboratory parameters within 2 days prior to the beginning of treatment on Day -3:
United States, Ohio | |
Case Western Reserve University School of Medicine | |
Cleveland, Ohio, United States, 44106-7728 |
Principal Investigator: | Kenneth Cooke | Case Western Reserve University School of Medicine |
Responsible Party: | University Hospitals ( Amy Wakeling ) |
Study ID Numbers: | E5564-A001-102 |
Study First Received: | September 18, 2008 |
Last Updated: | November 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00756912 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ANC BMT graft versus leukemia graft vs. host disease MD2 (endotoxin binding-protein) |
undergo allogeneic BMT myeloablative conditioning therapy |
Graft Versus Host Disease Leukemia Graft vs Host Disease Homologous Wasting Disease |
Leukemia Neoplasms Neoplasms by Histologic Type |