A Randomized Phase I/II Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for Patients With Unresectable Pancreatic Cancer

Inclusion Criteria:

- Phase I patients should have treatment naïve pancreatic cancer; however , Phase I
patients who have had 1 prior regimen consisting of adjuvant chemo-radiation or
adjuvant gemcitabine - as defined within the NCCN guidelines may be enrolled. Phase
II patients must have metastatic disease (Stage IV only).

- Karnofsky performance status of >70%

- Adequate liver function. (total bilirubin ≤ 1.5 mg/dL and AST(SGOT) and ALT(SGPT) of
< 2.5 ULN ( ≤ 5 ULN for Phase II patients with liver metastases), Serum Creatinine <
1.5 ULN

- Adequate bone marrow function as documented by the following laboratory test results
within 14 days of starting therapy. platelets ≥100,000/mm3, absolute neutrophil count
(ANC) ≥1500/mm3, hemoglobin ≥9.0 g/dL, white blood cell (WBC) count ≥3000 /mm3

- Practice effective contraception during the entire study period.

- Life expectancy of more than 3 months.

- Able and willing to sign the informed consent form.

- Willing and able to self-administer orally and document all doses of RTA 402
ingested.

Exclusion Criteria:

- Prior treatment for current malignancy outside of the adjuvant setting for Phase I

- Inability to swallow tablets or capsules

- Active brain metastases or primary central nervous system (CNS) malignancies.
(Patients with a previously treated brain metastasis may be included.)

- Active second malignancy

- Ten percent or greater weight loss over the 6 weeks before study entry.

- Pregnant or breast feeding

- Clinically significant illnesses which could compromise participation in the study,
including, but not limited to: Uncontrolled diabetes; Active or uncontrolled
infection; Acute or chronic liver disease; Confirmed diagnosis of Human
immunodeficiency virus (HIV) infection; Uncontrolled hypertension, symptomatic
congestive heart failure, unstable angina pectoris, myocardial infarction within the
past 6 months, or uncontrolled cardiac arrhythmia.

- Psychiatric illness that would limit compliance with study requirements.