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Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy
Cancer, 10/20/09

Arpornwirat W et al. – This randomized, double-blind, dose-ranging, placebo-controlled, phase 2 trial evaluated the neurokinin-1 receptor antagonist casopitant mesylate in combination with ondansetron/dexamethasone (ond/dex) for the prevention of chemotherapy-induced nausea and vomiting (CINV) related to moderately emetogenic chemotherapy (MEC). Casopitant plus ond/dex was more effective than ond/dex alone for the prevention of CINV.

Methods

Chemotherapy-naive patients who were receiving MEC (N = 723) randomized to receive either oral placebo or casopitant at doses of 50 mg, 100 mg, or 150 mg daily (on Days 1-3) plus ondansetron (on Days 1-3) and dexamethasone (Day 1)
Two exploratory arms evaluated single-dose casopitant (150 mg) plus ond/dex and 3-day casopitant regimen with once-daily ondansetron and dexamethasone
2 exploratory arms evaluated single-dose casopitant (150 mg) plus ond/dex and 3-day casopitant regimen with once-daily ondansetron and dexamethasone
Primary endpoints rates of complete response (CR) (no vomiting, retching, rescue therapy, or premature discontinuation) and significant nausea (SN) (≥ 25 mm on a visual analog scale) over first 120 hours after Cycle 1 of MEC
Secondary endpoints included acute and delayed CR and SN rates, rates of nausea, vomiting, and safety

Results

All casopitant doses that were tested significantly increased proportion of patients with CR: CR rates 80.8% with casopitant 50 mg, 78.5% with casopitant 100 mg, and 84.2% with casopitant 150 mg compared with 69.4% in control group (P = .0127); casopitant 150 mg identified as minimally effective dose
In exploratory analyses, single-dose casopitant demonstrated 79.2% CR rate, and once-daily ondansetron plus casopitant produced 83.5% CR rate
Vomiting rates in first 5 days after MEC reduced with casopitant-containing regimens (from 23% to 10%-16%)
Rates of SN did not differ among treatment arms (range, 28%-29%)
Casopitant appeared well tolerated with no notable differences in overall adverse event frequency

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