Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation
Completed · Early Phase 1
Conditions studied: Nausea, Vomiting
In brief
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 ondansetron and intravenous or oral dexamethasone in the autologous transplant setting.
Key facts
- Study ID
- NCT00314743
- Run by
- Washington University School of Medicine
- People needed
- 48
- Starts
- 2005-10-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2013-05-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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