Neurokinin-1 antagonist orvepitant for EGFRI-induced pruritus in patients with cancer: a randomised, placebo-controlled phase II trial.

ABSTRACT:

Objective

To evaluate the efficacy of orvepitant (10 or 30 mg given once daily, orally for 4 weeks), a neurokinin-1 receptor antagonist, compared with placebo in reducing the intensity of epidermal growth factor receptor inhibitor (EGFRI)-induced intense pruritus.

Design

Randomised, double-blind, placebo-controlled clinical trial.

Setting

15 hospitals in Italy and five hospitals in the UK.

Participants

44 patients aged ≥18 years receiving an EGFRI for a histologically confirmed malignant solid tumour and experiencing moderate or intense pruritus after EGFRI treatment.

Intervention

30 or 10 mg orvepitant or placebo tablets once daily for 4 weeks (randomised 1:1:1).

Primary and secondary outcome measures

The primary endpoint was change from baseline

SUBMITTER: Vincenzi B 

PROVIDER: S-EPMC7045265 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature