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

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
aprepitant
Comparator: ondansetron
Comparator: dexamethasone
Comparator: fosaprepitant dimeglumine
Comparator; Placebo (unspecified)
Comparator; Placebo (unspecified)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    1

    2

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of Patients Who Reported No Vomiting
    The number of patients who reported No Vomiting in the overall phase in Cycle 1

    Secondary Outcome Measures

    Number of Patients Who Reported Complete Response
    The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.

    Full Information

    First Posted
    June 14, 2006
    Last Updated
    May 2, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00337727
    Brief Title
    Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2007 (Actual)
    Primary Completion Date
    October 28, 2008 (Actual)
    Study Completion Date
    November 19, 2008 (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 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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    848 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    2
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    aprepitant
    Other Intervention Name(s)
    MK0869
    Intervention Description
    aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: ondansetron
    Other Intervention Name(s)
    Zofran®
    Intervention Description
    Ondansetron 8 mg capsule Three day treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: dexamethasone
    Other Intervention Name(s)
    DEXAMETHASONE TABLETS USP
    Intervention Description
    dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: fosaprepitant dimeglumine
    Other Intervention Name(s)
    EMEND®
    Intervention Description
    fosaprepitant dimeglumine 115 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator; Placebo (unspecified)
    Intervention Description
    dexamethasone 12mg Pbo tablets.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator; Placebo (unspecified)
    Intervention Description
    Aprepitant 80 mg & 125 mg Pbo capsules.
    Primary Outcome Measure Information:
    Title
    Number of Patients Who Reported No Vomiting
    Description
    The number of patients who reported No Vomiting in the overall phase in Cycle 1
    Time Frame
    Overall phase (0-120 hours post initiation of MEC) in Cycle 1.
    Secondary Outcome Measure Information:
    Title
    Number of Patients Who Reported Complete Response
    Description
    The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.
    Time Frame
    Overall phase (0-120 hours post initiation of MEC) in Cycle 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    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

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    19568773
    Citation
    Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer. 2010 Apr;18(4):423-31. doi: 10.1007/s00520-009-0680-9. Epub 2009 Jul 1.
    Results Reference
    result
    PubMed Identifier
    24911369
    Citation
    Rapoport BL. Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region. Curr Med Res Opin. 2014 Sep;30(9):1875-81. doi: 10.1185/03007995.2014.925866. Epub 2014 Jun 12.
    Results Reference
    derived
    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

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

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