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EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting

Phase 2
18 Years
Open (Enrolling)
Nausea, Vomiting

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Trial Information

EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Overall proportion of participants with no vomiting or retching

Outcome Time Frame:

Up to 120 hours following initiation of chemotherapy

Safety Issue:



Canada: Health Canada

Study ID:




Start Date:

October 2011

Completion Date:

July 2013

Related Keywords:

  • Nausea
  • Vomiting
  • Nausea
  • Vomiting