Timing of Start of systemIc Treatment for Asymptomatic Metastasized Pancreatic Cancer

Inclusion Criteria:

• Signed, written Institutional Review Board/Ethics Committee-approved Informed ConsentForm (ICF).
• Patients with histologically/cytological confirmed diagnosis of metastatic pancreaticductal adenocarcinoma.
• Measurable disease on computed tomography (CT) scan per RECIST version 1.1 criteria.
• Eastern Cooperative Oncology Group Performance Status of 0-1
• Life expectancy ≥ 3 months.
• Age ≥ 18 years.
• A negative urine or serum pregnancy test within 7 days before Day 1 (first dose ofstudy medication) if female subject is of childbearing potential.
• Screening clinical laboratory values as follows:

1. Absolute neutrophil count > 1.5 x 109 /L
2. Total bilirubin ≤ 1.5 times upper limit of normal (ULN).
3. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times ULN, (ifliver metastases are present, then ≤ 5 times ULN is allowed).
4. Serum creatinine < 1.5 x ULN or creatinine clearance >50 mL/min/1.73 m2
5. Prothrombin time/international normalized ratio within normal limits (± 15%) orwithin therapeutic range if subject takes warfarin. Partial thromboplastin time (PTT) within normal limits (± 15%).
6. Platelet count > 100,000 x 109 /L

• No symptoms related to advanced disease, specified as:

1. no pain requiring regular narcotic analgesics;
2. no weight loss over 5 kg (unless related to surgery or other illness);
3. no persistent nausea requiring medication;
4. no obstructive bowel symptoms;
5. no persistent fever related to metastatic cancer;
6. no other symptom which in the opinion of the clinician was due to progressivemetastatic cancer.

• No prior chemotherapy for metastatic disease (patients might have received adjuvanttreatment more than 6 months before the development of metastatic disease, orneoadjuvant treatment before surgery for resectable disease)

Exclusion Criteria:

• Known central nervous system involvement or brain metastases.
• New York Heart Association Class III or IV cardiac disease or myocardial infarctionwithin the past 12 months
• Any other disease, active, uncontrolled bacterial, viral or fungal infection requiringsystemic therapy, metabolic dysfunction, physical examination finding or clinicallaboratory finding that leads to reasonable suspicion of a disease or condition thatcontraindicates the use of an investigational drug, that may affect the interpretationof the results, or that may render the subject at high risk for treatmentcomplications.
• Inability to comply with study and follow-up procedures as judged by the Investigator.
• Women currently pregnant or breastfeeding.