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

Completed

• Conditions: Patient Safety
• Interventions: Drug: Elunate®

• Registration Number: NCT04005066
• Lead Sponsor: Hutchmed

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-04-18
• Study Start: 2019-04-20
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Primary Completion: 2022-09-27
• Study Completion: 2022-09-27
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3005

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Elunate®	* Currently using Elunate® or will use Elunate®(Fruquintinib) within a week; * Provision of informed consent by the patient.

Primary Outcome Measures

Name	Time	Method
Incidence of ADRs	from the first administration of fruquintinib up to 6 months	% of patients with ADRs according to CTCAE 4.03
Incidence of AEs	from the first administration of fruquintinib up to 6 months	% of patients with AEs according to CTCAE 4.03
Incidence of SAEs	from the first administration of fruquintinib up to 6 months	% of patients with SAEs according to CTC AE 4.03
Incidence of AESI	from the first administration of fruquintinib up to 6 months	% of patients with AESI according to CTC AE 4.03

Trial Locations

Locations (1)

Shanghai Dongfang Hospital; 🇨🇳 Shanghai, China