NCT04005066

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,005

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

April 20, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2022

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

3.4 years

First QC Date

April 18, 2019

Last Update Submit

December 15, 2022

Conditions

Patient Safety

Outcome Measures

Primary Outcomes (4)

  • Incidence of AEs

    % of patients with AEs according to CTCAE 4.03

    from the first administration of fruquintinib up to 6 months

  • Incidence of ADRs

    % of patients with ADRs according to CTCAE 4.03

    from the first administration of fruquintinib up to 6 months

  • Incidence of SAEs

    % of patients with SAEs according to CTC AE 4.03

    from the first administration of fruquintinib up to 6 months

  • Incidence of AESI

    % of patients with AESI according to CTC AE 4.03

    from the first administration of fruquintinib up to 6 months

Study Arms (1)

Cohort 1

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

Drug: Elunate®

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).

Also known as: Fruquintinib
Cohort 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Advanced solid tumor patients treated with Elunate®( fruquintinib) in Chinese real world practice

You may qualify if:

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

You may not qualify if:

  • Unsuitable for the study according to investigator's judgement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Dongfang Hospital

Shanghai, China

Location

MeSH Terms

Interventions

HMPL-013

Study Officials

  • Mandy Xue

    Hutchmed

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

July 2, 2019

Study Start

April 20, 2019

Primary Completion

September 27, 2022

Study Completion

September 27, 2022

Last Updated

December 19, 2022

Record last verified: 2022-12

Locations

CN(1)