E7080-M000-213 Anaplastic Thyroid Cancer
Research type
Research Study
Full title
An Open-Label, Single-Arm, Multicenter, Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)
IRAS ID
199959
Contact name
Christopher Nutting
Contact email
Sponsor organisation
Eisai
Eudract number
2015-001929-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 25 days
Research summary
This is an open-label, which means both researcher and participants will know which treatment is being administered, single arm, multicentre Phase 2 study to evaluate the efficacy and safety of lenvatinib in participants with anaplastic thyroid cancer (ATC). The purpose of this study is to evaluate how effective and safe the drug lenvatinib is in patients who have ATC. ATC is a rare and aggressive type of cancer that often spreads to other parts of the body (metastatic) and does not have an established standard chemotherapy (treatment of disease by chemical agents). \n\nLenvatinib is thought to work by stopping the formation of new blood cells that help cancer cells grow and spread. It is hoped that lenvatinib may offer a new treatment option that will be more effective than the standard drugs used for this type of cancer.\n\nThis study will involve patients >18 years of age with ATC. It consists of 3 Phases: a Pretreatment Phase (Screening and Baseline Visit), a Treatment Phase (starting Cycle 1 Day 1) and a Posttreatment Phase (end of treatment visit and survival follow up). The participant will remain on treatment until disease progression, and will then go into lifetime follow-up.\n
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/1799
Date of REC Opinion
6 Dec 2016
REC opinion
Further Information Favourable Opinion