A Study of CP-4126 in Patients With Advanced Pancreatic Cancer

Inclusion criteria

• Histological or cytological confirmed advanced pancreatic cancer*
• Not eligible for curative resection
• Performance Status (ECOG) 0-2
• Estimated life expectancy of at least 12 weeks
• Age ≥ 18 years
• Adequate haematological and biological functions:

• Neutrophils ≥ 1.5 x 109/L
• Platelets > 100.0 x 109/L
• Hb ≥ 10 g/dL
• AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN), if liver metastases
• AST/ALT ≤ 5 x institutional ULN and ALP ≤ 4 x institutional ULN
• Bilirubin ≤ 1.5 times institutional ULN, if liver metastases ≤ 3 x institutional ULN
• Serum creatinine ≤ 1.5 times institutional ULN
• Signed informed consent

Exclusion criteria

• Prior chemotherapy for metastatic disease
• Symptomatic brain metastases
• Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
• Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
• History of allergic reactions to gemcitabine or egg
• Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
• Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
• Pregnant or breastfeeding women
• Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment
• Known positive status for HIV
• Any reason why, in the investigator's opinion, the patient should not participate in the study.
• Drug or alcohol abuse
• Prior radical resection, but exploratory laparotomy as well palliative (e.g bypass) surgery are allowed