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

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01405924
First received: July 28, 2011
Last updated: October 24, 2014
Last verified: October 2014

July 28, 2011
October 24, 2014
October 2011
December 2013   (final data collection date for primary outcome measure)
Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ] [ Designated as safety issue: No ]
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.
Overall proportion of participants with no vomiting or retching [ Time Frame: Up to 120 hours following initiation of chemotherapy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01405924 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From 24 to 120 hours following initiation of chemotherapy in Cycle 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ] [ Designated as safety issue: No ]
    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.
Proportion of participants with no vomiting or retching per type of chemotherapy [ Time Frame: Up to 120 hours following initiation of chemotherapy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)
EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Nausea
  • Vomiting
  • Drug: Fosaprepitant dimeglumine
    Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2
    Other Name: MK-0517, EMEND® IV
  • Drug: 5-HT3 RA
    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.
  • Drug: Dexamethasone
    Dexamethasone will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.
  • Drug: Rescue medication
    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.
Experimental: Fosaprepitant 150 mg
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
Interventions:
  • Drug: Fosaprepitant dimeglumine
  • Drug: 5-HT3 RA
  • Drug: Dexamethasone
  • Drug: Rescue medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
111
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01405924
0517-030
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP