NCT02161991

Aprepitant for Chemotherapy Induced Nausea and Vomiting in Chinese Advanced Non-small Cell Lung Cancers

Randomized Phase 3 Study of Aprepitant Versus Placebo in Chinese Advanced Non-small Cell Lung Cancer Who Received Highly Emetogenic Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence aprepitant plasma concentration, which may lead to the individual difference of CINV control rate.

Detailed description

Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2014 V2),the patient should receive standard platinum based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant 125 mg at day1, then 80 mg at day2 and day3. In placebo group, patients would receive placebo from day1 to day3. In both group, dexamethasone and 5-HT inhibitor palonosetron were give at the same dose. During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV, other side-effects should be recorded. In aprepitant group, plasma should be taken for the analyze of plasma concentration, gene polymorphism of CYP3A4 and NK-1 should be analyzed for all the patients who received aprepitant if possible.

Conditions

• Carcinoma, Non-small Cell Lung

Interventions

Type	Name	Description
DRUG	Aprepitant	aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
DRUG	placebo	placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-02-01
• Completion: 2018-01-31
• First posted: 2014-06-12
• Last updated: 2020-03-26

Locations

1 site across 1 country: China