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An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071)

NCT ID: NCT00092183

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

866 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-10

Study Completion Date

2004-02-11

Brief Summary

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This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.

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Detailed Description

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Conditions

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Nausea Vomiting Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0869, aprepitant / Duration of Treatment: 3 days

Intervention Type DRUG

Comparator: ondansetron / Duration of Treatment: 3 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.

Exclusion Criteria

* Patient has a central nervous system malignancy.
* Patient will receive radiation to the abdomen or pelvis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005 Apr 20;23(12):2822-30. doi: 10.1200/JCO.2005.09.050.

Reference Type BACKGROUND
PMID: 15837996 (View on PubMed)

Study Documents

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Document Type: CSR Snyopsis

View Document

Other Identifiers

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MK0869-071

Identifier Type: -

Identifier Source: secondary_id

2004_063

Identifier Type: -

Identifier Source: secondary_id

0869-071

Identifier Type: -

Identifier Source: org_study_id

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