OPKO Health, Inc. (NYSE: OPK) today announced that the Phase 3 clinical program for rolapitant is currently enrolling patients. This global program consists of two randomized, double-blind and placebo controlled clinical trials evaluating the efficacy of a single 200mg oral dose of rolapitant in patients receiving highly emetogenic chemotherapy, or HEC, and one clinical trial evaluating the efficacy of a single 200mg oral dose of rolapitant in patients receiving moderately emetogenic chemotherapy, or MEC. Approximately 2,400 cancer patients will participate.
Each of the HEC clinical trials consist of approximately 530 patients and is focused on evaluating rolapitant plus the standard of care compared with placebo plus the standard of care. The MEC clinical trial consists of approximately 1,350 patients and is focused on evaluating rolapitant plus the standard of care compared with placebo plus the standard of care. In each of the Phase 3 clinical trials the standard of care consists of a 5-HT3 receptor antagonist in combination with the corticosteroid dexamethasone.
The patients in these clinical trials are being evaluated for evidence of an improvement in control of nausea and vomiting during the acute (0 – 24 hours), delayed (24 – 120 hours) and overall (0 – 120 hours) time periods post administration of chemotherapy. The primary outcome of each trial will be based on complete response (defined as no emetic episodes and no use of rescue medication) in the delayed phase. Additional outcome measures include complete response for other time points, the incidence and severity of nausea, and safety and tolerability. Results from each of the clinical trials are anticipated in the second half of 2013.
Rolapitant, a potent and selective neurokinin-1 (NK-1) receptor antagonist with an extended plasma half-life, is currently in Phase 3 clinical testing for prevention of chemotherapy induced nausea and vomiting (CINV). Phase 2 testing in cancer patients treated with highly emetogenic chemotherapy demonstrated promising five-day activity in CINV prevention following the administration of a single dose. The safety and tolerability of single and repeat doses of rolapitant has been assessed in over 1,000 subjects. Rolapitant is an investigational agent and has not been approved by regulatory agencies.