Combination With Gemcitabine in Advanced Pancreatic Cancer

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

Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.

Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.

Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.

Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.

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 </= 1
• Eastern Cooperative Oncology Group performance status (ECOG PS) </= 2
• 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