Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer

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 incombination with other agents; at regular, not radiosensitizing, doses) foradvanced/metastatic pancreatic cancer

• Measurable or nonmeasurable disease by RECIST criteria (at least one target ornontarget 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 ofcontraception (surgical sterilization or the use of barrier contraception with eithera condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry intothe study through 6 months after the last dose

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

Exclusion Criteria:

• More than one prior systemic therapy regimen for metastatic/locally advancedpancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of initialradiotherapy do not count as a prior systemic therapy regimen)

• Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemicantitumor therapy for pancreatic cancer within 14 days prior to study start

• Symptomatic brain metastases (baseline CT scan is not required in asymptomaticsubjects)

• 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 riskof cardiovascular instability, uncontrolled hypertension, clinically significantpericardial effusion, or congestive heart failure

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

• Major surgery within 3 weeks of the start of study treatment, without completerecovery

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