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OPKO Health Inc Announces Start Of Phase 3 Clinical Trials Of Rolapitant For Prevention Of CINV
OPKO Health Inc announced that the Phase 3 clinical program for rolapitant is 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 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.
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