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news.OPKO Health has initiated patient enrollment in Phase III clinical trials of rolapitant for the prevention of chemotherapy induced nausea and vomiting (CINV).
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The program is comprised of two randomized, double-blind and placebo controlled trials.
One trial will evaluate the efficacy of a single 200mg oral dose of rolapitant in patients receiving highly emetogenic chemotherapy, or HEC.
Another trial will evaluate the efficacy of a single 200mg oral dose of rolapitant in patients receiving moderately emetogenic chemotherapy, or MEC.
The primary outcome of each trial will be based on complete response in the delayed phase and additional outcome measures include complete response for other time points, the incidence and severity of nausea, and safety and tolerability.
The company expects to report results from each of the trials in the second half of 2013.