Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group
Inclusion Criteria
Eligibility Criteria:
- Metastatic and/or locally advanced GIST, with diagnosis based on histology with
positive c-kit and/or DOG-1, or with a GIST-typical mutation in KIT or PDGFR
- Measurable disease on CT (computed tomography) as defined by RECIST criteria; at
least one measurable lesion not given radiotherapy
- History of progressive disease on CT according to RECIST criteria after both imatinib
and sunitinib treatment, and also after nilotinib if this drug has been given
- No other TKIs given than imatinib, sunitinib and nilotinib
- Age at least 18 years at the time of diagnosis of GIST
- WHO performance status 0-2
- Resolution of all toxic side effects from earlier TKI treatment and any other
potential non-TKI treatment to grade 1 or below
- Sufficient organ functions as defined in the protocol
- Absence of earlier or present certain other conditions as defined in the protocol
- No pregnancy or lactation
- Women with childbearing potential must accept the use of adequate contraception
throughout the study period
- Written informed consent