Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation

Nausea Clinical Trial

Official title:

A Study Evaluating the Efficacy and Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combination With Ondansetron and Dexamethasone in Patients Undergoing Autologous Peripheral Blood Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314743
• Other study ID #: 03-1192
• Status: Completed
• Phase: Phase 0
• First received: April 12, 2006
• Last updated: May 22, 2013
• Start date: October 2005
• Est. completion date: December 2008

Study information

• Verified date: May 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 ondansetron and intravenous or oral dexamethasone in the autologous transplant setting.

Other known NCT identifiers

• NCT00285272

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Drug:
• Ondansetron

• Dexamethasone

• Aprepitant

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of aprepitant in preventing acute & delayed chemotherapy induced nausea & vomiting when administered in combination with intravenous or oral ondansetron & intravenous or oral dexamethasone in the autologous transplant setting.		Day 30	No
Secondary	To measure the the severity, frequency, and duration of chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to a control group, not receiving aprepitant.		Day 30	No
Secondary	To measure the need for breakthrough antiemetics in patients receiving aprepitant and compare these results to the control group		Day 30	No
Secondary	To assess the incidence of complications associated with chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to the control group.		Day 30	No
Secondary	To assess the safety of aprepitant in combination with ondansetron and dexamethasone in the autologous transplant setting.		Day 30	Yes

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine