Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer

Inclusion Criteria

• Subject has provided signed informed consent. Fully understands requirements of the trial and willing to comply with all trial visits and assessments.
• Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas and availability of tumor sample.
• Evidence of disease (not necessarily measurable disease). Complete tumor assessment including chest X ray, CT scan of abdomen and other scans as necessary to document all sites of disease performed within 28 days prior to trial entry/randomization.
• Age ≥ 18 years.
• Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For the purposes of this trial, women of childbearing potential is defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive."
• Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during and four weeks after the last dose of trial medication. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device. The use of hormonal contraceptives should be avoided in female subjects of childbearing potential due to a possible drug-drug interaction.

Exclusion Criteria

• Bone marrow impairment as evidenced by hemoglobin less ( 1.5 x upper limit of normal (ULN), and/or calculated creatinine clearance 1.5 x ULN, or aspartate aminotransferase/ alanine aminotransferase (AST/ALT) > 2.5 x ULN, for subjects with liver involvement AST/ALT > 5 x ULN.
• Serum calcium > 1 x ULN.
• History of central nervous system (CNS) metastases, unless subject has been previously treated for CNS metastases, is stable by CT scan without evidence of cerebral edema, and has no requirements for corticosteroids or anticonvulsants.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 1.
• Significant cardiac conduction abnormalities, including QT interval corrected for heart rate (QTc) prolongation of > 480 milliseconds (ms) and/or pacemaker.
• Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of uveitis or history of retinal vein occlusion.