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

Inclusion Criteria: * At least 18 years of age * Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy; previously treated with at least one chemotherapy regimen for advanced or metastatic disease or no effective standard treatment is available OR * Metastatic and/or locally advanced, inoperable pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided) * 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 * Women of childbearing potential and men to use effective means of contraception from entry into the study through 6 months after the last dose * Ability to understand the purposes and risks of the study and provide written informed consent. 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