Eisai/ E7080-G000-211
Research type
Research Study
Full title
A Multicenter, Randomized, Double-blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With 131 I-Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 20 mg or 14 mg Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile.
IRAS ID
199576
Contact name
Kate Newbold
Contact email
Sponsor organisation
Eisai Ltd.
Eudract number
2014-005199-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
This is a multicentre, randomised, double-blind study of lenvatinib. Lenvatinib is a drug that is being developed for many cancer types and has been approved in the U.S., Europe and Japan for the treatment of radioiodine-refractory differentiated thyroid cancer (a particular type of thyroid cancer that has become resistant to radioactive iodine treatment). The purpose of this study is to find out if there is a lower dose of lenvatinib that will cause fewer side effects and work as well as the current dose (24 mg) for treating radioiodine resistant thyroid cancer.
The starting daily doses of 20mg or 14mg will be compared with a starting daily dose of 24 mg. This study is for patients with radioiodine-refractory differentiated thyroid cancer. The patients will have medical tests to prove their disease has worsened within the last 12 months to confirm they can participate in this study.
This study will be done at about 100 research centres located in North America, Europe, Russia, South Korea and Australia. The study will include approximately 210 patients with this type of cancer. The study is expected to last up to 42 months.
Since this is a randomised, double-blind study, patients will be randomly assigned (by a computer) to receive 14 mg, 20mg or 24mg doses. Neither the patients nor the study doctor will know what dose the patient has been assigned. All patients will undergo the same tests and scans in the study so that a scientifically accurate comparison can be made.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0321
Date of REC Opinion
7 Dec 2016
REC opinion
Further Information Favourable Opinion