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

HUTCHMED

Status and phase: Completed; Phase 4

Conditions: Patient Safety

Treatments: Drug: Elunate®

Study type: Observational

Funder types: Industry

Identifiers

NCT04005066

2018-013-00CH2

Details and patient eligibility

About

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

Full 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).

Enrollment: 3,005 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

3,005 participants in 1 patient group

Cohort 1

Description:

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

Treatment:

Drug: Elunate®