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

December 15, 2022 updated by: Hutchmed

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

3005

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Dongfang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advanced solid tumor patients treated with Elunate®( fruquintinib) in Chinese real world practice

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
  • Currently using Elunate® or will use Elunate®(Fruquintinib) within a week;
  • Provision of informed consent by the patient.
Drug: Elunate®
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of AEs
Time Frame: from the first administration of fruquintinib up to 6 months
% of patients with AEs according to CTCAE 4.03
from the first administration of fruquintinib up to 6 months
Incidence of ADRs
Time Frame: from the first administration of fruquintinib up to 6 months
% of patients with ADRs according to CTCAE 4.03
from the first administration of fruquintinib up to 6 months
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
from the first administration of fruquintinib up to 6 months
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
from the first administration of fruquintinib up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hutchmed

Investigators

  • Study Director: Mandy Xue, Hutchmed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2019

Primary Completion (Actual)

September 27, 2022

Study Completion (Actual)

September 27, 2022

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-013-00CH2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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