A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine

Inclusion Criteria:

- At least 18 years of age

- Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology
(CT- or endoscopic-guided)

- Metastatic pancreatic cancer

- Disease progression during or after treatment with gemcitabine (alone or in
combination with other agents; at regular, not radiosensitizing, doses) for
advanced/metastatic pancreatic cancer

- Measurable or nonmeasurable disease by RECIST criteria (at least one target or
nontarget lesion)

- Recovered from reversible toxicities of prior therapy

- Karnofsky performance status ≥70

- All women of childbearing potential and all men must agree to use effective means of
contraception (surgical sterilization or the use of barrier contraception with either
a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into
the study through 6 months after the last dose

- Ability to understand the purposes and risks of the study and has signed a written
informed consent form approved by the investigator's IRB/Ethics Committee

Exclusion Criteria:

- More than one prior systemic therapy regimen for metastatic/locally advanced
pancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of
initial radiotherapy do not count as a prior systemic therapy regimen)

- Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic
antitumor therapy for pancreatic cancer within 14 days prior to study start

- Symptomatic brain metastases (baseline CT scan is not required in asymptomatic
subjects)

- Active clinically significant infection requiring antibiotics

- Known HIV positive or active hepatitis B or C

- Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or
4), particularly coronary artery disease, arrhythmias or conduction defects with risk
of cardiovascular instability, uncontrolled hypertension, clinically significant
pericardial effusion, or congestive heart failure

- No other active malignancies (other than treated non-melanoma skin cancer or treated
in situ cancer) within the past year

- Major surgery within 3 weeks of the start of study treatment, without complete
recovery

- Clinically significant abnormalities in laboratory test results (including complete
blood count, chemistry panel including electrolytes, and urinalysis) (Hemoglobin <9
g/dL (may receive transfusion or erythropoietin to maintain))