A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer

Inclusion Criteria:

- Male or female patients ≥18 years of age

- Histological or cytologically confirmed locally advanced, inoperable or metastatic
pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery

- Patients must have at least one uni-dimensional measurable lesion by CT or MRI
according to RECIST, Version 1.1

- Resolution of all acute toxic effects of any prior local treatment to Common
Terminology Criteria for Adverse Events (CTCAE) Grade
- Eastern Cooperative Oncology Group performance status (ECOG PS)
- Patient has cardiac function, within normal range, as measured by an echocardiogram

Exclusion Criteria:

- Known history of, or symptomatic metastatic brain or meningeal tumors

- History of cardiac disease

- Active clinically serious infections

- Clinically significant (ie. symptomatic) peripheral vascular disease

- Pregnant or lactating women; women of childbearing potential not employing adequate
contraception

- Use of strong inhibitors or inducers of CYP3A4

- Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic
cancer, or other malignancy

- Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers
to radiation therapy in adjuvant intention if given within 6 months from start of
study treatment

- Thrombotic or embolic events such within 6 months prior to start of study treatment