A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer

Subjects enrolled to assess safety will receive a combination of Gemcitabine plus RX-0201. Gemcitabine will be administered prior to RX-0201 intravenously in a 30-min iv infusion dose at 1000 mg/m2 once weekly for up to 2 cycles; each 4-week cycle consist of 3-week treatment phase followed by 1 week resting phase. RX-0201 will be administered at 250 mg/m2/day in a 24-hour continuous intravenous infusion for up to 2 cycles; each 3-week cycle consists of 2-week treatment phase followed by a 1 week resting phase. (See schedule of assessments)Subjects enrolled to evaluate efficacy will receive a combination of Gemcitabine and RX-0201 as outline above for up to 4 cycles.

Inclusion criteria

• Provide written informed consent prior to the initiation of study procedures.
• Are > 18 years of age
• Have metastatic pancreatic cancer.
• Have at least 1 measurable lesion by RECIST criteria.
• Have a Karnofsky Performance Status of > 70.
• Have at least a 6-month life expectancy as assessed by the investigator.
• Pre-menopausal women must be surgically sterile or agree to use an accepted method of birth control while participating in the study and for 30 days following the last exposure of study drug. Acceptable forms of birth control are: hormonal contraceptives (oral, injectable, transdermal or implant), double-barrier contraceptives (condom or diaphragm with spermicide), and intrauterine device (IUD).
• Male subjects need to either be surgically sterile or agree to use a barrier method of birth control described above during the study and for 30 days following the last exposure to study drug. The subject's agreed upon method of birth control will be discussed and documented in the subjects source document during the screening phase of the study.

Exclusion criteria

• Are unwilling or unable to provide informed consent.
• Are unwilling or unable to comply with the requirements of the protocol.
• Have been treated with another investigational agent for pancreatic cancer.
• Have any of the following screening laboratory values:

• Hemoglobin < 8.0 grams/deciliter (g/dL)
• Absolute neutrophil count (ANC) < 1500/microliter (μL)
• Platelet count < 100,000/μL
• Serum creatinine > 1.5 x the institutional upper limit of normal (IULN) creatinine.
• Serum bilirubin > 1.5 X IULN
• Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase, SGOT) > 2 x IULN (> 5 x IULN in presence of known liver metastasis)
• Alanine transaminase (ALT) (serum glutamate pyruvate transaminase, SGPT) > 2 x IULN (> 5 x IULN in presence of known liver metastasis)
• Have a prothrombin time >1.25 x IULN on screening laboratory assessments.
• HCV or HBsAg positive subjects
• Have received therapeutic dose of either warfarin or heparin within 21 days before Day 1 (the first day of dosing; prophylactic use of warfarin or heparin) to maintain patency of indwelling IV catheters/lines is allowed
• Have a history of brain cancer (primary or metastatic).
• Have a history of an active hematologic malignancy within the past 2 years.
• Have an underlying diagnosis or disease state associated with an increased risk of bleeding (i.e., coagulopathies, HIV).
• Have a serious infection requiring intravenous antibiotic therapy during screening.
• Females who are pregnant, lactating, or have a positive serum pregnancy test during the screening period.