Patient SafetyNCT04005066
A Phase IV Study of Elunate® (Fruquintinib) in Chinese Patients
An observational study of Patient Safety, run by Hutchmed at 1 site in China.
Trial summary
A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Safety
- What is being tested?
- Elunate®
- Type of treatment
- Pill or oral medicine
- How many people
- 3,005 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2019to 27 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Advanced solid tumor patients treated with Elunate®( fruquintinib) in Chinese real world practice
Who may be able to join
- Currently using Elunate®(Fruquintinib) or will use Elunate®(Fruquintinib) within a week;
- Provision of informed consent by the patient.
Who cannot join
- Unsuitable for the study according to investigator's judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-Marketing Clinical Study to Evaluate the Safety of Elunate® (Fruquintinib Capsules) in Chinese Patients.
A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients
Read the detailed 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).
- Conditions
- Patient Safety
- Being tested
- Elunate®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elunate®Drug
Also called Fruquintinib
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).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | * Currently using Elunate® or will use Elunate®(Fruquintinib) within a week;
* Provision of informed consent by the patient. Receives: Drug: Elunate® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs
% of patients with AEs according to CTCAE 4.03
Measured: from the first administration of fruquintinib up to 6 months
Incidence of ADRs
% of patients with ADRs according to CTCAE 4.03
Measured: from the first administration of fruquintinib up to 6 months
Incidence of SAEs
% of patients with SAEs according to CTC AE 4.03
Measured: from the first administration of fruquintinib up to 6 months
Incidence of AESI
% of patients with AESI according to CTC AE 4.03
Measured: from the first administration of fruquintinib up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start20 Apr 2019
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- More trials run by HutchmedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mandy Xue, Study director, Hutchmed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005066
- Sponsor's protocol ID
- 2018-013-00CH2
- Status last verified
- Dec 2022
- First submitted
- 18 Apr 2019
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Clinical Study to Evaluate the Safety of Elunate® (Fruquintinib Capsules) in Chinese Patients.
- ClinicalTrials.gov ID
- NCT04005066
- Acronym / sponsor ID
- 2018-013-00CH2
- Conditions
- Patient Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,005 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Elunate®* Currently using Elunate® or will use Elunate®(Fruquintinib) within a week; * Provision of informed consent by the patient. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Advanced solid tumor patients treated with Elunate®( fruquintinib) in Chinese real world practice
Key inclusion criteria (2 listed)
- Currently using Elunate®(Fruquintinib) or will use Elunate®(Fruquintinib) within a week;
- Provision of informed consent by the patient.
Key exclusion criteria (1 listed)
- Unsuitable for the study according to investigator's judgement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elunate®Also: FruquintinibThe 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). | Drug | Cohort 1 |
Primary outcome
Incidence of AEs
Time frame: from the first administration of fruquintinib up to 6 months
% of patients with AEs according to CTCAE 4.03
Incidence of ADRs
Time frame: from the first administration of fruquintinib up to 6 months
% of patients with ADRs according to CTCAE 4.03
Incidence of SAEs
Time frame: from the first administration of fruquintinib up to 6 months
% of patients with SAEs according to CTC AE 4.03
Incidence of AESI
Time frame: from the first administration of fruquintinib up to 6 months
% of patients with AESI according to CTC AE 4.03
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandy Xue study director
Hutchmed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety, run by Hutchmed at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs (time frame: from the first administration of fruquintinib up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.