E7080 in Medullary and Iodine-131 Refractory Thyroid Cancers
Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology.
This is a multi-centre, open-label, single arm trial of an experimental drug called E7080 in patients with Medullary Thyroid Cancer (MTC), or Differentiated Thyroid Cancer (DTC) that's refractory/resistant to Iodine-131 treatment and unresectable (the cancer cannot be removed). The study is sponsored by Eisai Limited in Europe and Eisai Inc. in the USA.One of E7080??s mechanisms of action as an anti-cancer treatment is as a VEGF-inhibitor, which slows down the formation of the new blood vessels that are needed for cancers to grow.The study is being done to see if E7080 is effective; primarily if it reduces the size of participants?? tumours and to ensure that the drug is safe. The study will also look to determine the way in which the drug is processed by the body and the relationship that this has to the action of the drug. In addition, it will look at the overall effects of the drug on controlling the participant's cancer in terms of response times, overall disease progression and survival. 117 participants were enrolled in this multinational study, which runs across approximately 50 study sites in Europe and the USA. Enrollment is now closed. The study consists of a screening period; 28-day treatment cycles, study termination/final visit and survival follow up. Participants are withdrawn if they show evidence of disease progression, unacceptable toxicity, or if they withdraw consent. During the study, all participants receive the study drug E7080. The drug is a tablet which is taken once per day, orally, as a 24mg starting dose. In order to manage toxicities, the 24mg dose may be reduced or discontinued according to the Study Protocol.
West of Scotland REC 1
Date of REC Opinion
6 May 2009
Further Information Favourable Opinion