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Completed

NCT Number: NCT02161991

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hunan Cancer hospital

Changsha, Hunan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients pathologic diagnosed of advanced non-small cell lung cancer
  • according to NCCN non-small cell lung cancer guide line(2014 V2), patients are suitable for platinum based chemotherapy.

Exclusion criteria

  • patients could not receive platinum based chemotherapy judged by clinical doctors
  • pregnancy or breast-feeding women
  • any serious disease which could not be controled
  • urine protein≥++, or 24h urine protein>1g
  • less than 18 years old or more than 75 years old

Treatment and study plan

Aprepitant

Drug

aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.

Other names: Emend

Placebo

Drug

placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.

Primary outcomes

  1. complete response rate of CINV

    Time frame: during treatment, up to 6 months

    complete response rate of CINV should be recorded when platinum based chemotherapy begun, during inhospital treatment, up to 6 months

Secondary outcomes

  1. adverse event

    Time frame: during treatment, up to 6 months

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jun 12, 2014
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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