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

Tracking Information

First Received Date ^ICMJE

April 12, 2006

Last Updated Date

April 15, 2009

Start Date ^ICMJE

March 2006

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00314743 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Pilot 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

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Parallel Assignment

Condition ^ICMJE

Nausea
Vomiting

Intervention ^ICMJE

Drug: Carmustine, Etoposide, Cytarabine, Melphalan
Drug: Aprepitant, Carmustine, Etoposide, Cytarabine, Melphalan

Study Arms / Comparison Groups

Other: Control

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 or Multiple Myeloma
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
Known hypersensitivity to any component of study regimen
Pregnant or lactating women
Participating in a clinical trial which involves other investigational agent(s)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00314743

Responsible Party

John DiPersio, MD, PhD, Washington University School of Medicine

Study ID Numbers ^ICMJE

03-1192

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

John F DiPersio, M.D., Ph.D.

Washington University School of Medicine

Information Provided By

Washington University School of Medicine

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP