Phase 3 study of E7080 in patients with thyroid cancer
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of E7080 in 131 I-Refractory Differentiated Thyroid Cancer
IRAS ID
77556
Sponsor organisation
Eisai Ltd
Eudract number
2010-023783-41
Clinicaltrials.gov Identifier
Research summary
Thyroid cancer is a rare tumour type representing 1% of all cancers. It is three times more common in females (1-5% of all cancers in females and 2% in males).The current treatment of choice for patients with Differentiated Thyroid Cancer (DTC) is surgery whenever possible, followed by radiotherapy with iodine-131 and thyroxine therapy. Prognosis for thyroid cancer at time of diagnosis is generally good with a 10 year survival rate of 85%. However, for patients whose cancer cells are resistant to iodine-131 the 10 year survival rate is approximately 10%. The lack of effective treatment for iodine-131 resistant DTC has necessitated the development of new drugs. E7080 is a new experimental drug being developed for the treatment of different cancer types including DTC; it is thought to work by stopping the formation of new blood vessels that help cancer cells grow and spread. This is a multicentre, randomized double-blind study to measure the effects of E7080 taken orally, once daily in DTC patients who are 131-iodine resistant and whose cancer has returned within 12 months of treatment. Eligible participants will be randomized to receive either E7080 or matching placebo. Participants will continue to receive E7080 or placebo until disease progression (tumours grow, or new tumours appear), unacceptable toxicity or withdrawal of consent. Participants with disease progression who were taking placebo will have the option to receive E7080 is an open extension phase of the study. Study visits will be every 2 weeks during treatment, tumour assessment including CT and/or MRI scan(s) will be done every 8 weeks and bone scans will be done every 24 weeks.This study will be done at about 150 sites worldwide with approximately 360 participants. The study will take about 36 months to complete and is sponsored by Eisai
REC name
West of Scotland REC 1
REC reference
11/AL/0334
Date of REC Opinion
22 Jul 2011
REC opinion
Further Information Favourable Opinion