Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

Uncontrolled, Open-label, Non-randomized, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.

Inclusion Criteria:

• Male or female Chinese subjects >/- 18 years
• Advanced, histologically or cytologically confirmed solid tumors
• Subjects malignancies must be refractory to standard treatment or have no standard therapy available, or the subject actively refused any treatment that would be regarded standard, and/or if, in the judgment of the investigator or his/her designated associate(s), experimental treatment is clinically and ethically acceptable.
• Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1;
• Adequate bone marrow, liver and renal function
• Life expectancy of at least 3 months

Exclusion Criteria:

• Unstable/uncontrolled cardiac disease
• History of arterial or venous thrombotic or embolic events
• Malabsorption condition
• Severe renal impairment; persistent proteinuria >/= Grade 3
• Symptomatic metastatic brain or meningeal tumors
• Clinically significant bleeding >/=Grade 3 within 30 days before start of study medication.