Spots Global Cancer Trial Database for Ph II Nintedanib vs. Ifosfamide in Soft Tissue Sarcoma
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Trial Identification
Brief Title: Ph II Nintedanib vs. Ifosfamide in Soft Tissue Sarcoma
Official Title: A Phase II Multicenter Study Comparing the Efficacy of the Oral Angiogenesis Inhibitor Nintedanib With the Intravenous Cytotoxic Compound Ifosfamide for Treatment of Patients With Advanced Metastatic Soft Tissue Sarcoma After Failure of Systemic Non-oxazaphosporine-based First Line Chemotherapy for Inoperable Disease "ANITA"
Study ID: NCT02808247
Conditions
Study Description
Brief Summary: This is a prospective, multicentric, randomized, open label Phase II trial investigating whether the oral angiogenesis inhibitor nintedanib, as compared to the intravenous cytotoxic compound ifosfamide, given for patients with advanced, inoperable and/or metastatic STS after failure of first line chemotherapy prolongs progression-free survival. The primary objective of the trial is to evaluate whether nintedanib given as second-line therapy for advanced, inoperable and/or metastatic STS prolongs progression-free survival when compared with ifosfamide. Secondary objectives are to evaluate the efficacy of nintedanib as compared to ifosfamide in terms of progression-free survival rate at 12 weeks, overall survival, objective response rate, patient benefit rate, response duration, total duration of treatment with nintedanib safety, Health related Quality of Life and Health Economics. Exploratory objectives include an analysis of putative predictive biomarkers for the anti-tumor effects of the investigational agent nintedanib.treatment.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet, Brussels, , Belgium
Cliniques Universitaires Saint-Luc (121), Brussels, , Belgium
U.Z. Leuven - Campus Gasthuisberg (147), Leuven, , Belgium
Institut Bergonie, Bordeaux, , France
Centre Leon Berard (227), Lyon, , France
Gustave Roussy (225), Villejuif, , France
Vilnius University Hospital Santariskiu Santaros Clinics Klinikos (9453), Vilnius, , Lithuania
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (301), Amsterdam, , Netherlands
Leiden University Medical Centre (310), Leiden, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw, , Poland
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia), Barcelona, , Spain
Hospital Universitario San Carlos (366), Madrid, , Spain
Royal Marsden Hospital - Chelsea, London (613), London, , United Kingdom
Contact Details
Name: Patrick Schoeffski, MD
Affiliation: U.Z. Leuven - Campus Gasthuisberg (147)
Role: PRINCIPAL_INVESTIGATOR
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