Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
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.