NCT00090207

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
477

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2004

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

August 25, 2004

Last Update Submit

April 20, 2017

Conditions

NauseaVomiting

Outcome Measures

Primary Outcomes (1)

  • Patient vomiting

Secondary Outcomes (1)

  • Number of rescue therapies

Interventions

MK0869, aprepitant / Duration of Treatment: 3 daysDRUG
Comparator: ondansetron / Duration of Treatment: 4 daysDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schmoll HJ, Aapro MS, Poli-Bigelli S, Kim HK, Park K, Jordan K, von Pawel J, Giezek H, Ahmed T, Chan CY. Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. Ann Oncol. 2006 Jun;17(6):1000-6. doi: 10.1093/annonc/mdl019. Epub 2006 Mar 8.

    PMID: 16524979BACKGROUND

MeSH Terms

Conditions

NauseaVomiting

Interventions

AprepitantDuration of Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2004

First Posted

August 27, 2004

Study Start

January 13, 2004

Primary Completion

September 30, 2004

Study Completion

September 30, 2004

Last Updated

April 24, 2017

Record last verified: 2017-04