Trial intelligence / Profile preview

Aprepitant for CINV Prevention in Nondrinking Women with GI Cancer

NCT03674294Phase 3

Key facts

Status: Completed
Start: Aug 2015
Primary completion: Mar 2020
Countries: 1
Sponsor: Sun Yat-sen University
Modality: Small Molecules

Drugs: aprepitant
Conditions: chemotherapy-induced nausea and vomiting (CINV)

Overview

Phase 3, randomised, double-blind trial in chemotherapy-induced nausea and vomiting (CINV) comparing Aprepitant Arm with Placebo Arm (2 arms). Primary endpoint: Complete response rate during the overall phase. Started Aug 2015; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Aprepitant Arm
Aprepitant + Palonosetron + Dexamethasone
Placebo Arm
Placebo + Palonosetron + Dexamethasone

Who it enrols

Adult female patients (18-50 years) with gastrointestinal carcinoma, ECOG 0-1, and no history of long-term or excessive alcohol intake (<5 times/week, <100g/day). Patients must be receiving their first FOLFOX or FOLFIRI regimen. Excludes pregnant women, those with GI obstruction, CNS disease, or contraindications to glucocorticoids.

Endpoints

Primary

Complete response rate during the overall phaseOverall phase (Day 1-5)

Secondary

Complete response rate in the acute phaseAcute phase (0-24 hours)
Complete response rate in the delayed phaseDelayed phase (24-120 hours)
No vomiting rate in the acute phase, delayed phase and overall phaseOverall phase
Affection caused by CINV reported by patientsUp to 1-2 months
Effects of CINV on daily lifeUp to 1-2 months

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