Skip to main content
OpenTrials
Completed

NCT Number: NCT04005066

A Phase IV Study of Elunate® (Fruquintinib) in Chinese Patients

A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patient Safety

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Dongfang Hospital

Shanghai, China

About this study

This study is a prospective, open-label, multi-center, study design to obtain the safety information of participant after medication. The follow-up time points for each participant include first time signing the informed consent form,1 month after signing the informed consent form, 6 months after signing the informed consent form or 30 days after the last dose (whichever occurs first).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Currently using Elunate®(Fruquintinib) or will use Elunate®(Fruquintinib) within a week;
  • Provision of informed consent by the patient.

Exclusion criteria

  • Unsuitable for the study according to investigator's judgement.

Treatment and study plan

Elunate®

Drug

The recommended dose is 5 mg once daily (1 capsule, each capsule contains 5 mg of fruquintinib); three weeks of continuous drug administration followed by one week of drug free period (4 weeks as one treatment cycle).

Other names: Fruquintinib

Primary outcomes

  1. Incidence of AEs

    Time frame: from the first administration of fruquintinib up to 6 months

    % of patients with AEs according to CTCAE 4.03

  2. Incidence of ADRs

    Time frame: from the first administration of fruquintinib up to 6 months

    % of patients with ADRs according to CTCAE 4.03

  3. Incidence of SAEs

    Time frame: from the first administration of fruquintinib up to 6 months

    % of patients with SAEs according to CTC AE 4.03

  4. Incidence of AESI

    Time frame: from the first administration of fruquintinib up to 6 months

    % of patients with AESI according to CTC AE 4.03

Sponsors and collaborators

Lead sponsor

Hutchmed

Industry

Registry information

Official study title

A Post-Marketing Clinical Study to Evaluate the Safety of Elunate® (Fruquintinib Capsules) in Chinese Patients.

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2019
Registry last updated
Dec 19, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.