A Phase 2, Open Label, Single Arm Trial of TPI 287 in Patients With Advanced, Unresectable Pancreatic Cancer After Prior Treatment With a Gemcitabine-based Therapy

Inclusion Criteria:

- Patients must have histological or cytological confirmation of ductal adenocarcinoma
or undifferentiated carcinoma of the pancreas

- Patients must have metastatic disease precluding curative surgery

- Patients must have received only one prior systemic anticancer treatment for their
advanced disease, which must have included a gemcitabine-based therapeutic regimen
for advanced disease

- Patients may have received prior adjuvant therapy for their disease

- Patients must have a Karnofsky performance status ≥ 70 (Appendix I)

- Patients must be ≥ 18 years of age

- Women of childbearing potential (WOCBP):

- Must be using an adequate method of contraception to avoid pregnancy throughout
the study and for up to 4 weeks after the study

- Must have a negative serum or urine pregnancy test

- Patients must have adequate organ function:

- Bone marrow reserve as evidenced by: Absolute neutrophil count ≥1,500/uL,
Platelet count ≥ 100,000/uL

- Renal function as evidenced by serum creatinine ≥ 2.0 mg/uL

- Hepatic function as evidenced by: Serum total bilirubin < 2.0 mg/uL, SGOT/SGPT <
3X ULN for the reference lab (< 5X ULN for patients with known hepatic
metastases)

- Patient must have recovered from prior surgery, radiotherapy or other antineoplastic
therapy

- Patients or their legal representative must be able to read, understand, and sign the
informed consent to participate in the trial

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)