Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)

A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00090207

Enrollment

477

Registered

2004-08-27

Start date

2004-01-13

Completion date

2004-09-30

Last updated

2017-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Vomiting

Brief summary

A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin.

Interventions

DRUGComparator: ondansetron / Duration of Treatment: 4 days

DRUGMK0869, aprepitant / Duration of Treatment: 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient is greater than 18 years of age. * Patient is scheduled to receive his/her first course of cisplatin chemotherapy for a solid tumor. * Patient has a prognosis (life expectancy) greater than or equal to 3 months.

Design outcomes

Primary

Measure	Time frame
Patient vomiting	—

Secondary

Measure	Time frame
Number of rescue therapies	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026