Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor

Exclusion Criteria

• •Use of any unapproved tyrosine kinase inhibitors or investigational agents within 2 weeks or 6 half-lives of the agent, whichever is shorter, prior to receiving study drug
• •Participants who have had radiotherapy within 4 weeks prior to study entry
• •Major surgery, or significant traumatic injury within 4 weeks prior to study entry
• •Presence of symptomatic or uncontrolled brain or central nervous system metastases
• •Prior exposure to sorafenib
• •Prior exposure to regorafenib
• •Known or suspected allergy to the investigational agent or any agent given in association with this trial
• •Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy or other primary malignancy is neither currently clinically significant nor requiring active intervention
• •Clinically significant cardiac arrhythmias and/or patients who require anti-arrhythmic therapy (excluding beta blockers or digoxin)
• •History of clinically significant cardiac disease or congestive heart failure \> NYHA class 2. Patients must not have unstable angina or new-onset angina within the last 3 months or myocardial infarction within the past 6 months
• •Hypertension as defined by systolic blood pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg; recurrent or persistent or symptomatic increase by \> 20 mmHg (diastolic) or to systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg if previously within normal limits, 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 the 6 months before start of study medication
• •Ongoing infection of Grade 3 or higher
• •Patients with evidence of, or history of, bleeding diathesis. Any major hemorrhage or bleeding event of Grade 3 or higher within 4 weeks of start of study medication
• •Non-healing wound, ulcer or bone fracture
• •Renal failure requiring hemo-or peritoneal dialysis
• •Dehydration of Grade 2 or greater
• •Persistent proteinuria Grade 3 or higher
• •Known history of HIV infection or chronic hepatitis B or C
• •Uncontrolled intercurrent illness
• •Pregnant or lactating females