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Spots Global Cancer Trial Database for Nintedanib(BIBF1120) in Thyroid Cancer

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Trial Identification

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

Interventions

Nintedanib
Placebo

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Martin Schlumberger, MD

Affiliation: Gustave Roussy, Cancer Campus, Grand Paris

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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