EORTC phase II trial opens for patients with differentiated or medullary thyroid cancer progressing after first line therapy

Thyroid cancer is the most common endocrine malignancy. Its incidence has been increasing over the past three decades, and the age and gender-adjusted incidence has increased faster, in all ethnic backgrounds, than that of any other malignancy in recent years (Globocan). In Europe in 2008, there were nearly 50 000 new cases of thyroid cancer and roughly 6000 deaths, and treatment options for patients with advanced differentiated and medullary thyroid cancer who have progressed on one line of therapy are limited. There is no treatment considered as standard of care, and cytotoxic chemotherapy has not been shown to have a clinically meaningful benefit.

One potential way to treat thyroid cancer is to target angiogenesis pathways. Vascular endothelial growth factor receptors are intimately involved in the biology of tumor vasculature and are often overexpressed in thyroid cancer, as are receptors for fibroblast growth factor and platelet-derived growth factor. Nintedanib (BIBF1120) inhibits all three of these growth factor receptor types, so it is thought that this drug could inhibit tumor growth and perhaps also be active in patients who have progressed on agents that only target a single growth factor receptor pathway.

EORTC trial 1209, a randomized, blinded, placebo controlled, phase II trial, is now open and will explore the safety and efficacy of nintedanib as second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.

Dr. Martin Schlumberger of the Institut Gustave Roussy in Villejuif, France, and Coordinator of this study says, “This is a randomized phase II trial that evaluates the role of nintedanib, a potentially active drug, as second/third line treatment in patients with both differentiated and medullary thyroid cancer. This is a very interesting study, because there are very limited treatment options for this population.”

EORTC trial 1209 plans to accrue 150 patients and will be conducted in 36 sites in nine countries: Belgium, Denmark, France, Germany, Italy, Poland, Spain, The Netherlands, and the United Kingdom. This trial is led by the EORTC Endocrine Tumors Task Force and is supported by an educational grant from Boehringer-Ingelheim.

For more information concerning EORTC trial 1209 please contact: www.eortc.org/contact

John Bean, PhD
EORTC, Medical Science Writer