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Brief Title: Nintedanib(BIBF1120) in Thyroid Cancer
Official Title: A Phase II Study Exploring the Safety and Efficacy of Nintedanib (BIBF1120) as Second Line Therapy for Patients With Either Differentiated or Medullary Thyroid Cancer Progressing After First Line Therapy.
Study ID: NCT01788982
Brief Summary: For the treatment of thyroid cancer with the so called targeted therapy the angiogenesis pathway has several potential targets. The Receptors for Vascular endothelial growth factor (VEGF) and especially VEGFR-2 is considered to be crucial for the initiation of the formation as well as the maintenance of tumor vasculature. In thyroid cancer these VEGF receptors (VEGFR-1, VEGFR-2), VEGF itself and receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed. Other cells as pericytes and smooth muscle cells that are also involved in tumor angiogenesis express these receptors as well. Inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. However there is no treatment that is generally considered as standard of care for patients with differentiated thyroid cancer (DTC) or medullar thyroid cancer (MTC) who have progressed on one line of therapy. The classical cytotoxic chemotherapy has not shown a clinically meaningful benefit yet. Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF. Therefore it might act not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of this multi-kinase activity rationale exists to investigate the effect in MTC and DTC. Because it targets these three major angiogenesis signaling pathways it might prevent further tumor growth and related tumor escape mechanisms. Therefore nintedanib may be active in patients who have progressed on agents that target only one pathway.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
A.Z. St. Jan, Brugge, , Belgium
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, Antwerpen, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
U.Z. Leuven - Campus Gasthuisberg, Leuven, , Belgium
Odense University Hospital, Odense, , Denmark
CHU d'Angers, Angers, , France
Institut Bergonie, Bordeaux, , France
Centre Regional Francois Baclesse, Caen, , France
Centre Georges-Francois-Leclerc, Dijon, , France
Centre Leon Berard, Lyon, , France
Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis, Paris, , France
Assistance Publique - Hopitaux de Paris - La Pitié Salpétrière, Paris, , France
Centre Jean Godinot, Reims, , France
Institut Gustave Roussy, Villejuif, , France
Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern, Munich, , Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Azienda Ospedaliera Universitaria "Federico II", Napoli, , Italy
University Medical Center Groningen, Groningen, , Netherlands
Leiden University Medical Centre, Leiden, , Netherlands
Radboud University Medical Center Nijmegen, Nijmegen, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw, , Poland
Hospital General Vall D'Hebron, Barcelona, , Spain
Royal Marsden Hospital - Sutton, Surrey, Sutton, Surrey, United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital, Glasgow, , United Kingdom
Name: Martin Schlumberger, MD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: PRINCIPAL_INVESTIGATOR