Thyroid NeoplasmsNCT02430714
Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)
An observational study of Thyroid Neoplasms, run by Eisai Co., Ltd. at 2 sites in Japan.
Trial summary
This study is a post-marketing surveillance of lenvatinib in participants with unresectable thyroid cancer. The objectives of this study are to capture unknown adverse reactions, incidences of adverse drug reaction, efficacy, factors considered to have effect to safety and effectiveness, and incidences of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Lenvatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 629 participants
- Where
- 2 sitesJapan
- Study dates
- 20 May 2015to 6 Nov 2016
- 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: All participants with unresectable thyroid cancer and administrated Lenvatinib in Japan
Who may be able to join
- 1. All participants with unresectable thyroid cancer and administrated Lenvatinib.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
This study is a post-marketing surveillance of lenvatinib in participants with unresectable thyroid cancer. The objectives of this study are to capture unknown adverse reactions, incidences of adverse drug reaction, efficacy, factors considered to have effect to safety and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic event, and liver disorder.
- Conditions
- Thyroid Neoplasms
- Being tested
- Lenvatinib
- Keywords
- Thyroid Cancer, Lenvima, Post-marketing surveillance, LEN01T, All-Patient Investigation, Lenvatinib Mesylate
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Also called E7080, Lenvima
24mg once daily oral dosing to Unresectable thyroid cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | A prospective, centrally registered investigation will be conducted. The new administering participants are to be registered at the time of administration. Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)/adverse drug reactions (ADRs)
Measured: up to 1 year
Secondary outcomes (1)
Overall survival (OS)
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 posted30 Apr 2015 (estimated)
- Study start20 May 2015
- Primary completion6 Nov 2016
- Study completion6 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies 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
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yasunori Megumi, Study director, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430714
- Sponsor's protocol ID
- LEN01T
- Status last verified
- Jul 2018
- First submitted
- 27 Apr 2015
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)
- ClinicalTrials.gov ID
- NCT02430714
- Acronym / sponsor ID
- LEN01T
- Conditions
- Thyroid Neoplasms
- Keywords
- Thyroid Cancer, Lenvima, Post-marketing surveillance, LEN01T, All-Patient Investigation, Lenvatinib Mesylate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2015 (actual)
- Primary completion
- 6 Nov 2016 (actual)
- Study completion
- 6 Nov 2016 (actual)
- First posted
- 30 Apr 2015 (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.
This study is a post-marketing surveillance of lenvatinib in participants with unresectable thyroid cancer. The objectives of this study are to capture unknown adverse reactions, incidences of adverse drug reaction, efficacy, factors considered to have effect to safety and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic event, and liver disorder.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Drug: LenvatinibA prospective, centrally registered investigation will be conducted. The new administering participants are to be registered at the time of administration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants with unresectable thyroid cancer and administrated Lenvatinib in Japan
Key inclusion criteria (1 listed)
- 1. All participants with unresectable thyroid cancer and administrated Lenvatinib.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LenvatinibAlso: E7080, Lenvima24mg once daily oral dosing to Unresectable thyroid cancer patients | Drug | Arm 1 |
Primary outcome
Number of participants with adverse events (AEs)/adverse drug reactions (ADRs)
Time frame: up to 1 year
1 secondary outcome
Overall survival (OS)
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 9 Jan 2020.
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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.
Yasunori Megumi study director
Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Neoplasms, run by Eisai Co., Ltd. at 2 sites in Japan.
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 1 inclusion and 0 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 (AEs)/adverse drug reactions (ADRs) (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 9 Jan 2020.