Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)

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

A Phase III, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Safety, Tolerability and Efficacy of MK0869/Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With High-Dose Cisplatin

This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.

Study Overview

Study Type

Interventional

Enrollment (Actual)

421

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:

Cycle 1:

  • Patient is scheduled to receive his/her first course of cisplatin chemotherapy at a dose of at least 70 mg/m^2 administered a maximum of 3 hours
  • Patient has a predicted life expectancy of at least 3 months
  • Patient is not pregnant

Cycle 2 (optional):

  • Participation in the study during the next cycle of chemotherapy is considered

appropriate by the investigator and will not pose unwarranted risk to the patient.

  • Satisfactory completion of the preceding cycle of chemotherapy and related

study procedures.

  • Patient will continue to receive the same chemotherapy regimen as in Cycle 1. The cisplatin dose may be reduced in subsequent cycle, as long as the new

dose is still no less than 70 mg/m^2.

Exclusion Criteria:

Cycles 1 & 2:

  • Patient will receive stem cell therapy in conjunction with cisplatin
  • Patient has an active infection or any uncontrolled disease (e.g. diabetes)
  • Patient will receive multiple-day chemotherapy with cisplatin
  • Patient will receive chemotherapy of moderate or high emetogenicity on the 6 days prior to cisplatin infusion or the 6 days following the cisplatin infusion
  • Patient has vomited within 24 hours prior to cisplatin infusion
  • Patient received or will receive radiation therapy to the abdomen

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aprepitant (MK-0869)
Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg
Placebo Comparator: Standard Therapy
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg
Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1
Time Frame: 0 to 120 hours

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

0 to 120 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Complete Response in the Acute Phase of Cycle 1
Time Frame: 0 to 24 hours

Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

0 to 24 hours
Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1
Time Frame: 25 to 120 hours

Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

25 to 120 hours
Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1
Time Frame: 0 to 120 hours

Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

0 to 120 hours
Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1
Time Frame: 0 to 24 hours
Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.
0 to 24 hours
Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1
Time Frame: 25 to 120 hours
Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy
25 to 120 hours
Proportion of Participants With No Impact on Daily Life in Cycle 1
Time Frame: 0 to 120 hours
The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. "No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life" was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best).
0 to 120 hours
Time to First Vomiting Episode in Cycle 1
Time Frame: 0 to 120 hours
Time from administration of chemotherapy to first vomiting episode.
0 to 120 hours

Collaborators and Investigators

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

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.

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)

August 25, 2009

Primary Completion (Actual)

April 4, 2010

Study Completion (Actual)

May 5, 2010

Study Registration Dates

First Submitted

July 31, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

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

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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