Phase II Study of Bevacizumab (Avastin®) in Myelofibrosis

Exclusion Criteria

• •Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• •Inadequately controlled hypertension (defined as systolic blood pressure \>140 and/or diastolic blood pressure \>90 mmHg on antihypertensive medications) within 4 weeks prior to entering this study
• •Any prior history of hypertensive crisis or hypertensive encephalopathy
• •New York Heart Association (NYHA) Grade II or greater congestive heart failure
• •Unstable angina
• •History of myocardial infarction within 6 months
• •History of stroke or transient ischemic attack within 6 months
• •History of Budd-Chiari Syndrome or portal vein thrombosis.
• •Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• •Symptomatic peripheral vascular disease
• •Evidence of bleeding diathesis or clinically significant coagulopathy
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days, or anticipation of the need for major surgical procedure during the course of the study
• •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device or bone marrow biopsy, within 7 days prior to study enrollment
• •Proteinuria at screening as demonstrated by either
• •* Urine protein:creatinine (UPC) ratio greater than or equal to 1.0 at screening OR
• •* Urinalysis with proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
• •History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intra-abdominal abscess within 6 months
• •Ongoing serious, non-healing wound, ulcer, or bone fracture
• •Known hypersensitivity to any component of bevacizumab
• •Patients with a history of DVT and/or a CNS thrombotic or hemorrhagic event within the past 6 months.
• •Patients on anticoagulation therapy for a variety of conditions such as prosthetic heart valves or chronic atrial fibrillation.