Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation
Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation
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.
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.