Fosaprepitant (EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030 AM1) (EVADE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01405924
First received: July 28, 2011
Last updated: January 23, 2014
Last verified: January 2014

July 28, 2011
January 23, 2014
October 2011
December 2013   (final data collection date for primary outcome measure)
Overall proportion of participants with no vomiting or retching [ Time Frame: Up to 120 hours following initiation of chemotherapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01405924 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Fosaprepitant (EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030 AM1)
EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting

This study will assess the efficacy of a single dose of fosaprepitant 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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Nausea
  • Vomiting
  • Drug: fosaprepitant dimeglumine
    150 mg intravenously (IV) on Day 1 of chemotherapy
    Other Name: MK-0517, EMEND® IV
  • Drug: 5HT3 RA
    5HT3 RA will be administered at the same dosage used in the first cycle of chemotherapy
  • Drug: dexamethasone
    dexamethasone will be administered at the same dosage used in the first cycle of chemotherapy
  • Experimental: Breast Cancers
    Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy
    Interventions:
    • Drug: fosaprepitant dimeglumine
    • Drug: 5HT3 RA
    • Drug: dexamethasone
  • Experimental: Gynecological Cancers
    Women with breast cancer receiving carboplatin-paclitaxel chemotherapy
    Interventions:
    • Drug: fosaprepitant dimeglumine
    • Drug: 5HT3 RA
    • Drug: dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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 carboplatin-paclitaxel 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
Not Provided
Merck Sharp & Dohme Corp.
January 2014

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