Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors

Exclusion Criteria

• •Patients eligible for this study must not meet ANY of the following criteria:
• •1. Poorly differentiated neuroendocrine carcinoma, or high grade neuroendocrine tumor.
• •2. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• •3. Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment.
• •4. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
• •5. Current treatment on another clinical trial.
• •6. Patients who are using other investigational agents or who had received investigational drugs within 4 weeks prior to study enrollment.
• •7. Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
• •8. Any of the following within the 12 months prior to starting study treatment:
• •myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and sponsor, the 6-month post-event-free period for a patient with a pulmonary embolus can be waived if due to advanced cancer. Appropriate treatment with anticoagulants is permitted.
• •9. Hypertension that cannot be controlled by medications (\> 160/100 mmHg despite optimal medical therapy).
• •10. Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
• •11. Known history of human immunodeficiency virus (HIV) seropositivity and/or is receiving anti-retroviral therapy.
• •12. Hepatitis B virus (HBV) or hepatitis C virus (HCV) with evidence of chronic active disease or receiving/requiring antiviral therapy.
• •13. History of receiving organ transplantation or immune disorders that require continuous immunosuppressant agent therapy.
• •14. Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the Investigator or a designated associate.
• •15. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would impart, in the judgment of the investigator and/or Sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.