Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)

May 2, 2017 updated by: Merck Sharp & Dohme LLC

A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)

The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

848

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1
  • Karnofsky score of 60 or greater

Exclusion Criteria:

  • Patient is scheduled to receive any dose of cisplatin
  • Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy
  • Any allergies to study drug or antiemetics
  • Taking CYP3A4 substrates/prohibited medication
  • Significant medical or mental conditions
  • Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours.
Drug: aprepitant
aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
Other Names:
  • MK0869
Drug: Comparator: ondansetron
Ondansetron 8 mg capsule Three day treatment period.
Other Names:
  • Zofran®
Drug: Comparator: dexamethasone
dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
Other Names:
  • DEXAMETHASONE TABLETS USP
Drug: Comparator; Placebo (unspecified)
dexamethasone 12mg Pbo tablets.
Drug: Comparator; Placebo (unspecified)
Aprepitant 80 mg & 125 mg Pbo capsules.
Other: 2
Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1.
Drug: Comparator: ondansetron
Ondansetron 8 mg capsule Three day treatment period.
Other Names:
  • Zofran®
Drug: Comparator: dexamethasone
dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
Other Names:
  • DEXAMETHASONE TABLETS USP
Drug: Comparator; Placebo (unspecified)
dexamethasone 12mg Pbo tablets.
Drug: Comparator; Placebo (unspecified)
Aprepitant 80 mg & 125 mg Pbo capsules.
Drug: Comparator: fosaprepitant dimeglumine
fosaprepitant dimeglumine 115 mg
Other Names:
  • EMEND®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Reported No Vomiting
Time Frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1.

The number of patients who reported No Vomiting in the overall phase in Cycle

1
Overall phase (0-120 hours post initiation of MEC) in Cycle 1.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Reported Complete Response
Time Frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1
The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.
Overall phase (0-120 hours post initiation of MEC) in Cycle 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

October 28, 2008

Study Completion (Actual)

November 19, 2008

Study Registration Dates

First Submitted

June 14, 2006

First Submitted That Met QC Criteria

June 14, 2006

First Posted (Estimate)

June 16, 2006

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0869-130
  • 2006_016 (Other Identifier: protocol number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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