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

Hutchmed3,005 enrolled

Overview

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

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

3,005

Conditions

Patient Safety

Interventions

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).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Dongfang Hospital

Shanghai, China

Outcomes

Primary Outcomes

Incidence of AEs

% of patients with AEs according to CTCAE 4.03

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

Incidence of ADRs

% of patients with ADRs according to CTCAE 4.03

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

Incidence of SAEs

% of patients with SAEs according to CTC AE 4.03

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

Incidence of AESI

% of patients with AESI according to CTC AE 4.03

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

Data from ClinicalTrials.gov

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