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Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030) (EVADE)

Primary Purpose

Nausea, Vomiting

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fosaprepitant dimeglumine
5-HT3 RA
Dexamethasone
Rescue medication
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with either breast or gynecological cancer
  • Receiving either AC-like or CT MEC
  • Experienced at least 1 episode of vomiting or retching during the first 5 days following Cycle 1 of chemotherapy that was thought to be due to chemotherapy. Received standard chemotherapy-induced nausea and vomiting (CINV) prophylaxis not containing aprepitant or fosaprepitant
  • No change in chemotherapy at Cycle 2
  • No change in Cycle 1 antiemetic regimen at Cycle 2
  • Eastern Cooperative Oncology Group (ECOG) status 0-1

Exclusion Criteria:

  • Requires increase in systemic corticosteroid therapy
  • Used benzodiazepines or opiates in the 48 hours prior to Cycle 2 chemotherapy
  • Received or will receive radiation therapy to the abdomen or pelvis in the week prior to Visit 1 or in Days 1-6 following chemotherapy
  • Vomited in the 24 hours prior to Treatment Day 1
  • Pregnant or breast-feeding
  • Participating in a study with aprepitant or fosaprepitant or has taken an investigational drug in the last 4 weeks
  • Symptomatic central nervous system metastasis
  • History of other malignancies in the last 2 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Fosaprepitant 150 mg

    Arm Description

    Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy
    A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following chemotherapy in Cycle 2 was calculated.

    Secondary Outcome Measures

    Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy
    A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following initiation of chemotherapy in Cycle 2 was calculated based on type of chemotherapy received.
    Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy
    A complete response is defined as no vomiting/no retching episodes and no use of rescue medication during the 120 hours following initiation of chemotherapy. The percentage of participants with a complete response during Cycle 2 of chemotherapy was calculated.
    Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy
    The FLIE Total Score is an 18-question quality-of-life questionnaire on the impact of nausea and vomiting (9 questions on nausea and 9 questions on vomiting) on daily life. Each question uses a visual analog scale (VAS) to rate the impact of nausea/vomiting from 1 to 7. FLIE Total Scores are calculated by summing the responses to the 18 questions and can range from 18-126 (18=a great deal of impairment, 126=no impairment), with a higher score indicating less impairment due to nausea and vomiting. "No Impact" on daily life was defined as a FLIE Total Score >108. Participants completed the FLIE questionnaire on the morning of Day 6 following initiation of chemotherapy in Cycle 2; their responses covered their experiences with nausea and vomiting over the previous 5 days.
    Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy
    Participants rated their degree of nausea in response to "How much nausea have you had over the last 24 hours?" using a 100-mm visual analog scale (VAS, 0=no nausea, 100=nausea as bad as it could be) on Days 2-6 following initiation of chemotherapy. No significant nausea was defined as VAS score <25 mm over the 24-120 hours following initiation of chemotherapy. The percentage of participants who experienced no significant nausea during Cycle 2 of chemotherapy was calculated.
    Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy
    Participants recorded any use of rescue medication for established nausea/vomiting in their daily diaries from initiation of chemotherapy infusion through the morning of Day 6. The percentage of participants who used no rescue medication during Cycle 2 of chemotherapy was calculated.

    Full Information

    First Posted
    July 28, 2011
    Last Updated
    July 26, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01405924
    Brief Title
    Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)
    Acronym
    EVADE
    Official Title
    EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Low enrollment
    Study Start Date
    October 25, 2011 (Actual)
    Primary Completion Date
    December 6, 2013 (Actual)
    Study Completion Date
    December 6, 2013 (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 assess the efficacy of a single dose of intravenous (IV) fosaprepitant (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3 antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting (CIV) in participants who experienced CIV in the first cycle of moderately emetic chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching in at least 20% of participants during the second cycle of MEC in participants who previously experienced vomiting during the first cycle of MEC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nausea, Vomiting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    111 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fosaprepitant 150 mg
    Arm Type
    Experimental
    Arm Description
    Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Fosaprepitant dimeglumine
    Other Intervention Name(s)
    MK-0517, EMEND® IV
    Intervention Description
    Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2
    Intervention Type
    Drug
    Intervention Name(s)
    5-HT3 RA
    Intervention Description
    5-HT3 RA will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Dexamethasone will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Rescue medication
    Intervention Description
    Rescue medication is defined as any medication used to relieve the symptoms of established nausea or vomiting. Multiple medications are permitted by the protocol and may be taken by the participant, including 5-HT3 antagonists, phenothiazines and benzodiazepines.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy
    Description
    A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following chemotherapy in Cycle 2 was calculated.
    Time Frame
    Up to 120 hours following initiation of chemotherapy in Cycle 2
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy
    Description
    A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following initiation of chemotherapy in Cycle 2 was calculated based on type of chemotherapy received.
    Time Frame
    Up to 120 hours following initiation of chemotherapy in Cycle 2
    Title
    Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy
    Description
    A complete response is defined as no vomiting/no retching episodes and no use of rescue medication during the 120 hours following initiation of chemotherapy. The percentage of participants with a complete response during Cycle 2 of chemotherapy was calculated.
    Time Frame
    Up to 120 hours following initiation of chemotherapy in Cycle 2
    Title
    Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy
    Description
    The FLIE Total Score is an 18-question quality-of-life questionnaire on the impact of nausea and vomiting (9 questions on nausea and 9 questions on vomiting) on daily life. Each question uses a visual analog scale (VAS) to rate the impact of nausea/vomiting from 1 to 7. FLIE Total Scores are calculated by summing the responses to the 18 questions and can range from 18-126 (18=a great deal of impairment, 126=no impairment), with a higher score indicating less impairment due to nausea and vomiting. "No Impact" on daily life was defined as a FLIE Total Score >108. Participants completed the FLIE questionnaire on the morning of Day 6 following initiation of chemotherapy in Cycle 2; their responses covered their experiences with nausea and vomiting over the previous 5 days.
    Time Frame
    From Day 1 (prior to initiation of chemotherapy in Cycle 2) to morning of Day 6 (up to ~120 hours following initiation of chemotherapy in Cycle 2)
    Title
    Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy
    Description
    Participants rated their degree of nausea in response to "How much nausea have you had over the last 24 hours?" using a 100-mm visual analog scale (VAS, 0=no nausea, 100=nausea as bad as it could be) on Days 2-6 following initiation of chemotherapy. No significant nausea was defined as VAS score <25 mm over the 24-120 hours following initiation of chemotherapy. The percentage of participants who experienced no significant nausea during Cycle 2 of chemotherapy was calculated.
    Time Frame
    From 24 to 120 hours following initiation of chemotherapy in Cycle 2
    Title
    Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy
    Description
    Participants recorded any use of rescue medication for established nausea/vomiting in their daily diaries from initiation of chemotherapy infusion through the morning of Day 6. The percentage of participants who used no rescue medication during Cycle 2 of chemotherapy was calculated.
    Time Frame
    Up to 120 hours following initiation of chemotherapy in Cycle 2

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with either breast or gynecological cancer Receiving either AC-like or CT MEC Experienced at least 1 episode of vomiting or retching during the first 5 days following Cycle 1 of chemotherapy that was thought to be due to chemotherapy. Received standard chemotherapy-induced nausea and vomiting (CINV) prophylaxis not containing aprepitant or fosaprepitant No change in chemotherapy at Cycle 2 No change in Cycle 1 antiemetic regimen at Cycle 2 Eastern Cooperative Oncology Group (ECOG) status 0-1 Exclusion Criteria: Requires increase in systemic corticosteroid therapy Used benzodiazepines or opiates in the 48 hours prior to Cycle 2 chemotherapy Received or will receive radiation therapy to the abdomen or pelvis in the week prior to Visit 1 or in Days 1-6 following chemotherapy Vomited in the 24 hours prior to Treatment Day 1 Pregnant or breast-feeding Participating in a study with aprepitant or fosaprepitant or has taken an investigational drug in the last 4 weeks Symptomatic central nervous system metastasis History of other malignancies in the last 2 years
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=0517-030&kw=0517-030&tab=access

    Learn more about this trial

    Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)

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