Opko Health is enrolling patients in the Phase 3 clinical programme for Rolapitant, designed for the prevention of chemotherapy induced nausea and vomiting (CINV).
Rolapitant is a selective neurokinin-1 (NK-1) receptor antagonist with an extended plasma half-life, and has showed promising five-day activity in CINV prevention following the administration of a single dose in a Phase 2 study.
NK-1 receptor antagonists have been proven to improve the management of nausea and vomiting experienced by cancer patients undergoing chemotherapy.
The Phase 3 programme includes two randomised double-blind and placebo controlled clinical trials, investigating the efficacy of a single 200mg oral dose of Rolapitant in patients receiving highly emetogenic chemotherapy (HEC), and in patients receiving moderately emetogenic chemotherapy (MEC).
The HEC trial will involve around 530 patients, while the MEC clinical trial will enrol approximately 1,350 patients to evaluate 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 comprises a 5-HT3 receptor antagonist in combination with the corticosteroid dexamethasone.
The trials are being evaluated for evidence of an improvement in control of nausea and vomiting during the acute (0-24hrs), delayed (24-120hrs) and overall (0-120hrs) time periods post administration of chemotherapy.
In the programme, 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.
The other outcome measures of the clinical trials include complete response for other time points, the incidence and severity of nausea, and safety and tolerability.
The company said findings from each of the clinical trials are likely to be reported in the second half of 2013.