Differentiated Thyroid Carcinoma (DTC)NCT02764554
Post-Marketing Surveillance of Lenvima in Korean Patients
An observational study of Differentiated Thyroid Carcinoma (DTC), run by Eisai Korea Inc. at 32 sites in South Korea.
Trial summary
The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of Lenvima (lenvatinib) in normal clinical practice setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Differentiated Thyroid Carcinoma (DTC)
- How many people
- 132 participants
- Where
- 32 sitesSouth Korea
- Study dates
- 10 Nov 2016to 29 Sep 2021
- 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: Participants who are prescribed with Lenvatinib per approved prescribing information of lenvatinib in normal clinical practice setting.
Who may be able to join
- Participants who meet the following criteria will be eligible for inclusion in the study:
- Participants with approved indication for lenvatinib in Korea
- Participants who have written consent for use of personal and medical information for the study purpose
Who cannot join
- Investigators will refer to approved indications and contraindications regarding exclusion criteria
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
South Korea32 sites
Eisai Trial Site #18
Anyang, Gyeongji-do
Eisai Trial Site #30
Bundang, Gyeongji-do
Eisai Trial Site #15
Busan
Eisai Trial Site #16
Busan
Eisai Trial Site #17
Busan
Eisai Trial Site #20
Busan
Eisai Trial Site #22
Busan
Eisai Trial Site #37
Busan
Eisai Trial Site #36
Daegu
Eisai Trial Site #4
Daegu
Eisai Trial Site #14
Goyang, Gyeongji-do
Eisai Trial Site #27
Goyang, Gyeongji-do
Eisai Trial Site #34
Goyang, Gyeongji-do
Eisai Trial Site #13
Gwangju
Eisai Trial Site #25
Incheon
Eisai Trial Site #26
Incheon
Eisai Trial Site #32
Incheon
Eisai Trial Site #19
Jeju City
Eisai Trial Site #1
Seoul
Eisai Trial Site #23
Seoul
Eisai Trial Site #29
Seoul
Eisai Trial Site #31
Seoul
Eisai Trial Site #33
Seoul
Eisai Trial Site #35
Seoul
Eisai Trial Site #38
Seoul
Eisai Trial Site #39
Seoul
Eisai Trial Site #8
Seoul
Eisai Trial Site #9
Seoul
Eisai Trial Site #21
Suwon, Gyeongji-do
Eisai Trial Site #12
Ulsan
Eisai Trial Site #6
Ulsan
Eisai Trial Site #24
Yangsan, Gyeongsangnam-do
About this study
The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of Lenvima (lenvatinib) in normal clinical practice setting.
- Conditions
- Differentiated Thyroid Carcinoma (DTC)
- Keywords
- Post-Marketing Surveillance, Lenvima, Lenvatinib, E7080, Differentiated thyroid carcinoma, Refractory to radioactive iodine, Progressive, locally recurrent, metastatic
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib 4 milligram (mg) and 10 mg capsule | Participants who are prescribed with Lenvatinib per approved prescribing information of lenvatinib in normal clinical practice setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start10 Nov 2016
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid Carcinoma (DTC)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764554
- Sponsor's protocol ID
- E7080-M065-502
- Status last verified
- Aug 2021
- First submitted
- 4 May 2016
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Lenvima in Korean Patients
- ClinicalTrials.gov ID
- NCT02764554
- Acronym / sponsor ID
- E7080-M065-502
- Conditions
- Differentiated Thyroid Carcinoma (DTC)
- Keywords
- Post-Marketing Surveillance, Lenvima, Lenvatinib, E7080, Differentiated thyroid carcinoma, Refractory to radioactive iodine, Progressive, locally recurrent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of Lenvima (lenvatinib) in normal clinical practice setting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib 4 milligram (mg) and 10 mg capsule | – | –Participants who are prescribed with Lenvatinib per approved prescribing information of lenvatinib in normal clinical practice setting. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who are prescribed with Lenvatinib per approved prescribing information of lenvatinib in normal clinical practice setting.
Key inclusion criteria (3 listed)
- Participants with approved indication for lenvatinib in Korea
- Participants who have written consent for use of personal and medical information for the study purpose
Key exclusion criteria (1 listed)
- Investigators will refer to approved indications and contraindications regarding exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions
Time frame: Up to 1 year
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 7 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Differentiated Thyroid Carcinoma (DTC), run by Eisai Korea Inc. at 32 sites in South Korea.
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 3 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 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in South Korea. 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?
Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions (time frame: Up to 1 year). 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 7 Oct 2021.