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NCT04005066 Clinical Trial

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

Patient Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04005066
Other study ID # 2018-013-00CH2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 20, 2019
Est. completion date September 27, 2022

Study information
Verified date December 2022
Source Hutchmed
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 3005
Est. completion date September 27, 2022
Est. primary completion date September 27, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
China Shanghai Dongfang Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Hutchmed

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of AEs % of patients with AEs according to CTCAE 4.03 from the first administration of fruquintinib up to 6 months
Primary Incidence of ADRs % of patients with ADRs according to CTCAE 4.03 from the first administration of fruquintinib up to 6 months
Primary Incidence of SAEs % of patients with SAEs according to CTC AE 4.03 from the first administration of fruquintinib up to 6 months
Primary Incidence of AESI % of patients with AESI according to CTC AE 4.03 from the first administration of fruquintinib up to 6 months
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