Status:
COMPLETED
Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation
Lead Sponsor:
Washington University School of Medicine
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine the efficacy of aprepitant in preventing acute and delayed chemotherapy induced nausea and vomiting when administered in combination with intravenous or oral ...
Eligibility Criteria
Inclusion
- Male or female patients 18 years of age or older
- Patients deemed eligible to undergo autologous bone marrow or peripheral stem cell transplant therapy per usual transplant inclusion and exclusion criteria
- Patients with Non-Hodgkins Lymphoma, Hodgkins Lymphoma or Multiple Myeloma or Amyloidosis
- Written informed consent
Exclusion
- Nausea at baseline
- Chronic use of other antiemetic agent(s)
- Gastrointestinal obstruction or active peptic ulcer
- Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
- Allogeneic stem cell transplant recipient
- Aspartate transaminase (AST) \> 3x upper limit of normal (ULN)
- Alanine transaminase (ALT) \> 3x ULN
- Bilirubin \> 3x ULN
- Alkaline phosphatase \> 3x ULN
- Creatinine \> 2
- Documented hypersensitivity to any component of study regimen
- Pregnant or lactating women
- Participating in a clinical trial which involves other investigational agent(s)
- Patients taking any of the following medications at time of study day 1: warfarin, oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and/or diltiazem.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00314743
Start Date
October 1 2005
End Date
December 1 2008
Last Update
May 24 2013
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110