A Phase II Trial of TPI 287 in Patients Advanced, Unresectable Pancreatic Cancer

Exclusion Criteria

• •Patients with islet cell tumors, lymphoma, or sarcoma of the pancreas
• •Patients with more than one prior treatment for metastatic pancreatic carcinoma
• •Patients with current peripheral neuropathy \> Grade 1
• •Patients receiving any concurrent chemotherapy, radiotherapy, hormonal therapy or immunotherapy
• •Patients with serious infection or a life-threatening illness (unrelated to tumor) that is \> Grade 2 NCI CTCAE V 3.0), or active, serious infections requiring parental antibiotic therapy within 4 weeks prior to screening
• •History of cardiac disease or events according to the New York Health Association (NYHA) assessments. Clinically evident congestive heart failure as defined by NYHA Class 3 or 4 CHF or cardiac arrhythmia, including atrial fibrillation, if not adequately controlled
• •Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results
• •Known HIV or Hepatitis B or C (active, previously treated or both)
• •A history of other malignancy (except nonmelanoma skin cancer or carcinoma-in-situ of cervix), unless in CR and not receiving therapy for that disease for a minimum of 5 years
• •Patients with known hypersensitivity to any of the components of the drugs to be administered on study
• •Patients receiving concurrent investigational therapy (investigational therapy is defined as treatment for which there is currently no regulatory authority-approved indication)