Table 1 Eligibility Criteria
Inclusion criteria | Exclusion criteria |
|---|---|
Written informed consent (IC) | Major surgery < 4 weeks prior to enrolment |
Histological confirmed advanced pancreatic adenocarcinoma | Weight loss > 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days |
At least one previous chemotherapy (gemcitabine-based) | PINI-Index > 10 |
≥ 18 years old | Pregnancy or breastfeeding |
Body weight ≥ 50 and ≤ 95 kg | > 4 weeks of parenteral nutrition within the last 6 months |
BMI ≥ 19 | Parenteral nutrition < 4 weeks prior to enrolment |
Negative pregnancy test (females of childbearing potential) | Vulnerable populations (e. g. subjects incapable of giving consent personally) |
Willingness to perform double-barrier contraception during study | Subject selection conflicts with warnings, precautions and contraindications stated for any investigational product |
Expected life expectancy > 3 months |