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

NCT ID: NCT04005066

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3005 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-20

Study Completion Date

2022-09-27

Brief Summary

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

Detailed Description

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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).

Conditions

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Patient Safety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

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

Elunate®

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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Fruquintinib

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hutchmed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mandy Xue

Role: STUDY_DIRECTOR

Hutchmed

Locations

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Shanghai Dongfang Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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2018-013-00CH2

Identifier Type: -

Identifier Source: org_study_id