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Study of MK0869 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (0869-071)(COMPLETED)

Primary Purpose

Nausea, Vomiting, Breast Neoplasms

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0869, aprepitant / Duration of Treatment: 3 days
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea focused on measuring Chemotherapy-Induced Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy. Patient must have completed participation in the main study for this protocol. Exclusion Criteria: Patient has a central nervous system malignancy. Patient will receive radiation to the abdomen or pelvis.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety and tolerability

    Secondary Outcome Measures

    Assessment of adverse experiences using the National Cancer Institute (NCI) criteria

    Full Information

    First Posted
    September 21, 2004
    Last Updated
    May 2, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092196
    Brief Title
    Study of MK0869 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (0869-071)(COMPLETED)
    Official Title
    Open-label Extension to: 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 Associated With Moderately Emetogenic Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2002 (Actual)
    Primary Completion Date
    December 1, 2004 (Actual)
    Study Completion Date
    December 1, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the efficacy and tolerability of an investigational drug for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nausea, Vomiting, Breast Neoplasms
    Keywords
    Chemotherapy-Induced Nausea and Vomiting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    820 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0869, aprepitant / Duration of Treatment: 3 days
    Primary Outcome Measure Information:
    Title
    Safety and tolerability
    Secondary Outcome Measure Information:
    Title
    Assessment of adverse experiences using the National Cancer Institute (NCI) criteria

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy. Patient must have completed participation in the main study for this protocol. Exclusion Criteria: Patient has a central nervous system malignancy. Patient will receive radiation to the abdomen or pelvis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16104039
    Citation
    Herrstedt J, Muss HB, Warr DG, Hesketh PJ, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Hustad CM, Horgan KJ, Skobieranda F; Aprepitant Moderately Emetogenic Chemotherapy Study Group. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and emesis over multiple cycles of moderately emetogenic chemotherapy. Cancer. 2005 Oct 1;104(7):1548-55. doi: 10.1002/cncr.21343. Erratum In: Cancer. 2006 Apr 1;106(7):1641.
    Results Reference
    background
    PubMed Identifier
    15837996
    Citation
    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. Erratum In: J Clin Oncol. 2005 Aug 20;23(24):5851. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.
    Results Reference
    background
    PubMed Identifier
    23062719
    Citation
    Aapro MS, Schmoll HJ, Jahn F, Carides AD, Webb RT. Review of the efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in a range of tumor types. Cancer Treat Rev. 2013 Feb;39(1):113-7. doi: 10.1016/j.ctrv.2012.09.002. Epub 2012 Oct 11.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Study of MK0869 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (0869-071)(COMPLETED)

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