A Phase II Study of Sorafenib in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors Who Failed to Imatinib and Sunitinib
This is a non-randomized, open-label, multi-center, phase II study recruiting patients with
advanced GIST who are pretreated with both imatinib and sunitinib. The current study will
provide an estimate of the activity and safety of sorafenib in GIST. The primary study
endpoint is the disease control rate (DCR), defined as complete or partial response or
stable disease of at least 24 weeks of sorafenib therapy. Secondary endpoints include PFS,
OS and safety.
Patients with advanced (unresectable and/or metastatic) GIST who failed after previous
therapy involving both imatinib and sunitinib will be eligible. Failure to imatinib and
sunitinib is defined as disease progression regardless of intervening response during
therapy, or intolerance. There is no limit to the number of prior therapies a patient may
have received (e.g., patients may have received therapy with nilotinib, other TKIs, or
chemotherapy in addition to imatinib or sunitinib).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-control rate
Six months after registration
No
Se Hoon Park, MD
Principal Investigator
Samsung Medical Center, Seoul, Korea
South Korea: Korea Food and Drug Administration (KFDA)
2009-08-102
NCT01091207
November 2009
August 2011
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