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

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea; Vomiting

Intervention: Ondansetron (Drug); Dexamethasone (Drug); Aprepitant (Drug)

Phase: Phase 0

Status: Completed

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
John F DiPersio, M.D., Ph.D., Principal Investigator, Affiliation: Washington University School of Medicine

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.

Clinical Details

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

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

Primary outcome: 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.

Secondary outcome:

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.

To measure the need for breakthrough antiemetics in patients receiving aprepitant and compare these results to the control group

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.

To assess the safety of aprepitant in combination with ondansetron and dexamethasone in the autologous transplant setting.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Washington University School of Medicine, St. Louis, Missouri 63110, United States
Additional Information

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

Starting date: October 2005
Last updated: May 22, 2013

Page last updated: August 23, 2015

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