regorafenib in gist with secondary c-kit exon 17 mutation

Conditions: Gastrointestinal Stromal Tumour (GIST)

Summary: the main purpose of this study is to examine whether regorafenib treatment can help people with gastrointestinal stromal tumours (gist) and have gene mutation on c-kit exon 17. the safety of regorafenib treatment is also examined.


Eligibility criteria:
inclusion criteria: an eligible subject must fulfill all of the following inclusion criteria: * signed informed consent (ic) obtained before any study specific procedure. patients must be able to understand and willing to sign the written ic. * pathologically confirmed gastrointestinal stromal tumours. * all patients had received imatinib or sunitinib. * pathological confirmed c-kit exon 17 mutation. * at least one measurable lesion in a non-irradiated area or allowed to be tracked whether there are circumstances recurrence by computed tomography (ct) or magnetic resonance imaging (mri). * aged \> 20 years old. * eastern cooperative oncology group (ecog) performance status 0 or 1. * life expectancy greater than 12 weeks. * adequate bone marrow function: 1) absolutely neutrophil count \>= 1.5 x10\^9/l or white blood cell count (wbc) \>= 4x10\^9/l; 2) hemoglobin \>= 9 g/dl; 3) platelet count \>= 100x10\^9/l. * adequate liver function: 1) total bilirubin \<= 1.5x the upper limit of normal (uln); 2) alanine aminotransferase (alt) \& aspartate aminotransferase (ast) \<= 2.5x uln if without liver metastasis or \<= 5x uln if with hepatic metastasis; 3) alkaline phosphatase \<= 2.5x uln if without liver metastasis or \<= 5x uln if with hepatic metastasis or bone metastasis; 4) bilirubin \< 2x uln. * adequate renal function: creatinine \<1.5x uln. * patients must be accessible for treatment and follow-up in the participating centers. exclusion criteria: subject will not meet any of the following exclusion criteria: * major surgery within four weeks prior to entering the study. * patients with central nervous system (cns) metastasis, including clinical suspicion. * patients who are under active or uncontrolled infections. * patients who with unstable angina (angina symptoms at rest, new-onset angina (begun within the last 3 months) or myocardial infarction history 6 months before entry. * cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). * congestive heart failure new york heart association (nyha) class 2. * uncontrolled hypertension (systolic blood pressure \[bp\] \> 150 mmhg or diastolic pressure \> 90 mmhg despite optimal medical management. * arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication. * patients who are pregnant or with breast feeding. * other concomitant or previously malignancy within 5 years except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only. * mental status is not fit for clinical trial. * cannot take study medication orally. * fertile men and women unless using a reliable and appropriate contraceptive method. * patients with evidence or history of any bleeding diathesis, irrespective of severity. * any hemorrhage or bleeding event \>= common terminology criteria for adverse events (ctcae) grade 3 within 4 weeks prior to the start of study medication. * non-healing wound, ulcer, or bone fracture. * renal failure requiring hemo-or peritoneal dialysis.