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Brief Title: Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib
Official Title: Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group
Study ID: NCT01524848
Brief Summary: Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who develop resistance against the two hitherto approved drugs for this disease, the tyrosin kinase inhibitors (TKIs) imatinib and sunitinib, have a poor prognosis. Sometimes a further response may be achieved by other drugs, mainly other TKIs, which have been explored in different studies but not yet have been approved for clinical use. Pazopanib is a TKI inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves investigational trials. The drug is approved for metastatic renal cancer and is relatively well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after 12 weeks of treatment will be assessed as the primary endpoint, and at the same time trough levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control rate in relation to trough level week 12 and in relation to the primary mutation of the tumor (if known). The goal is to include 72 patients in the trial, which is open and single arm.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aarhus University Hospital, dept. of Oncology, Aarhus, , Denmark
Herlev Hospital, dept. of Oncology, Herlev, , Denmark
Helsinki University Hospital, dept. of oncology, Helsingfors, , Finland
Kuopio University Hospital Cancer Center, Kuopio, , Finland
Klinik für Interdisziplinäre Onkologie, Sarkomzentrum Berlin-Brandenburg, Berlin, , Germany
Universitätsklinikum Essen, Innere klinik und Poliklinik, Essen, , Germany
Studienzentrale chirurgische klinik, Universitäts medizin Mannheim, Mannheim, , Germany
Dept of Oncology, Haukeland University Hospital, Bergen, , Norway
Norwegian Radium Hospital, Oslo, , Norway
Dept of Oncology, St Olav Hospital, Trondheim, , Norway
Dept of Oncology, Sahlgrenska University Hospital, Gothenburg, , Sweden
Dept of Oncology, Linköping University Hospital, Linköping, , Sweden
Dept of Oncology, Skane University Hospital, Lund, , Sweden
Radiumhemmet, Karolinska University Hospital, Stockholm, , Sweden
Dept of Oncology, Norrland University Hospital, Umeå, , Sweden
Dept of Oncology, Academic Hospital, Uppsala, , Sweden
Name: Mikael Eriksson, MD PhD
Affiliation: Scandinavian Sarcoma Group
Role: PRINCIPAL_INVESTIGATOR