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Brief Title: Ph II CABOGIST in GIST
Official Title: Phase II Study of Cabozantinib in Patients With Gastrointestinal Stromal Tumor (GIST) Who Progressed During Neoadjuvant, Adjuvant or Palliative Therapy With Imatinib and Sunitinib
Study ID: NCT02216578
Brief Summary: The study is a multi-center, multi-national, open label, single arm Phase II study of single-agent cabozantinib. The objective of the study is to assess the safety and activity of cabozantinib in patients with metastatic GIST who have previously progressed on imatinib and sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase inhibitors. Patient will receive cabozantinib until they experience no further benefit from the treatment, becoming intolerant to the drug or wishing to discontinue the treatment. Treatment beyond RECIST 1.1 progression is allowed in patients deriving clinical benefit upon investigator's discretion, provided no other criteria for treatment withdrawal are met.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
U.Z. Leuven - Campus Gasthuisberg (147), Leuven, , Belgium
University Hospital Motol (1905), Prague, , Czechia
Institut Bergonie (228), Bordeaux, , France
Centre Leon Berard (227), Lyon, , France
Gustave Roussy (225), Villejuif, , France
UniversitaetsMedizin Mannheim (527), Mannheim, , Germany
Military Hospital - State Health Centre (3769), Budapest, , Hungary
Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659), Bebington, , United Kingdom
Royal Marsden Hospital - Chelsea, London (613), Chelsea, , United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital (622), London, , United Kingdom
The Christie NHS Foundation Trust (610), Manchester, , United Kingdom
Name: Patrick Schöffski, MD
Affiliation: U.Z. Leuven -Campus Gasthuisberg, Leuven, Belgium
Role: PRINCIPAL_INVESTIGATOR