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

Primary Purpose

Chemotherapy-induced Nausea and Vomiting (CINV)

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
aprepitant
Comparator: Placebo to aprepitant
dexamethasone
granisetron
dexamethasone
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting (CINV) focused on measuring CINV

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Aprepitant (MK-0869)

    Standard Therapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1
    Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

    Secondary Outcome Measures

    Proportion of Participants With Complete Response in the Acute Phase of Cycle 1
    Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
    Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1
    Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
    Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1
    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).
    Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1
    Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.
    Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1
    Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy
    Proportion of Participants With No Impact on Daily Life in Cycle 1
    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).
    Time to First Vomiting Episode in Cycle 1
    Time from administration of chemotherapy to first vomiting episode.

    Full Information

    First Posted
    July 31, 2009
    Last Updated
    May 2, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00952341
    Brief Title
    Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 25, 2009 (Actual)
    Primary Completion Date
    April 4, 2010 (Actual)
    Study Completion Date
    May 5, 2010 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-induced Nausea and Vomiting (CINV)
    Keywords
    CINV

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Aprepitant (MK-0869)
    Arm Type
    Experimental
    Arm Title
    Standard Therapy
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    aprepitant
    Intervention Description
    Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo to aprepitant
    Intervention Description
    Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
    Intervention Type
    Drug
    Intervention Name(s)
    dexamethasone
    Intervention Description
    Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
    Intervention Type
    Drug
    Intervention Name(s)
    granisetron
    Intervention Description
    Day 1: IV granisetron 3 mg prior to administration of cisplatin
    Intervention Type
    Drug
    Intervention Name(s)
    dexamethasone
    Intervention Description
    Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg
    Primary Outcome Measure Information:
    Title
    Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1
    Description
    Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
    Time Frame
    0 to 120 hours
    Secondary Outcome Measure Information:
    Title
    Proportion of Participants With Complete Response in the Acute Phase of Cycle 1
    Description
    Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
    Time Frame
    0 to 24 hours
    Title
    Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1
    Description
    Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
    Time Frame
    25 to 120 hours
    Title
    Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1
    Description
    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).
    Time Frame
    0 to 120 hours
    Title
    Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1
    Description
    Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.
    Time Frame
    0 to 24 hours
    Title
    Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1
    Description
    Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy
    Time Frame
    25 to 120 hours
    Title
    Proportion of Participants With No Impact on Daily Life in Cycle 1
    Description
    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).
    Time Frame
    0 to 120 hours
    Title
    Time to First Vomiting Episode in Cycle 1
    Description
    Time from administration of chemotherapy to first vomiting episode.
    Time Frame
    0 to 120 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    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
    24276953
    Citation
    Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26.
    Results Reference
    result

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

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