Cabozantinib in Radioiodine-Refractory Differentiated Thyroid Cancer
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy
IRAS ID
259791
Contact name
Nicholas Reed
Contact email
Sponsor organisation
Exelixis, Inc.
Eudract number
2018-001771-21
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
113,446, IND
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Differentiated thyroid cancer (DTC) accounts for more than 90% of all newly diagnosed thyroid cancers. Thyroid cancer is about 2.5 times more common in women than in men, and its incidence has almost tripled from the mid-1990s through 2014.\n\nThe purpose of this study is to evaluate the effect of cabozantinib compared with a placebo in treating participants whose disease has progressed after receiving VEGFR-targeted therapy for their DTC. This study will also examine how safe and well tolerated cabozantinib is. \n\nAbout 300 eligible people will take part in this study. 200 people will be assigned to the cabozantinib treatment group (Group 1), and 100 people will be assigned to the placebo group (Group 2). \n\nThe total treatment duration in this study is expected to be about 9 months for each participant. Participants will be followed until death, withdrawal of consent, or Sponsor decision to no longer collect survival data.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0079
Date of REC Opinion
9 Apr 2019
REC opinion
Further Information Favourable Opinion