Status:
TERMINATED
Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Nausea
Vomiting
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2013
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01405924
Start Date
October 25 2011
End Date
December 6 2013
Last Update
August 27 2018
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