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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Neurokinin A; Ondansetron; Substance P

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.