Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
Status:
Completed
Trial end date:
2014-05-01
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
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.