Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled
study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered
prior to the initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects
will record all events of emesis and the 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 the MEC
administration through Day 6 in 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 examination, 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.