Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled
study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered 1-2
hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone.
Subjects will record all events of emesis and use of rescue medication for established nausea
and/or vomiting, and will indicate the severity of nausea they experienced in each of the
previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration
through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE
Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical
review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety
laboratory values.
All subjects are expected to complete Cycle 1 and will have the option of participating in up
to five additional cycles.