Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer

Exclusion Criteria

• •Prior chemotherapy for metastatic/locally advanced pancreatic cancer
• •Prior administration of gemcitabine
• •Radiation therapy within 28 days prior to study start
• •Hormonal therapy, biologic therapy, chemotherapy or other systemic anti-tumor therapy for cancer within 21 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
• •History or symptoms of cardiovascular disease (NYHA Class 3 or 4)
• •Other primary malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
• •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),
• •* ANC \<1500/μL,
• •* Platelet count \<100,000/μL,
• •* Total bilirubin \> 1.5 ×ULN,
• •* AST/ALT \> 2.5-fold above ULN (\>5-fold above ULN if liver metastases),
• •* Serum creatinine \> 2 mg/dL,
• •* Creatinine clearance \< 60 mL/min (calculated)
• •Females who are pregnant or breast-feeding
• •Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
• •Concomitant disease or condition that could interfere with the conduct of the study
• •Unwillingness or inability to comply with the study protocol for any other reason