An Open-label, Non-randomized Phase I Study of Regorafenib (BAY73-4506) to Evaluate Cardiovascular Safety Parameters, Tolerability, Pharmacokinetics, and Anti-tumor Activity in Patients With Advanced Solid Tumors

Inclusion Criteria:

- Male or female subjects >/= 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1

- Adequate bone marrow, liver, and renal function as assessed by the following
laboratory requirements to be conducted within 7 days prior to dosing:

- Hemoglobin (Hb) >/= 9.0 g/dL, Absolute neutrophil count (ANC) >/= 1500/mm³,
Platelet >/= 100,000/mm³, Total bilirubin (ULN), Alkaline phosphatase
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) times ULN ( International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) < 1.5
x ULN, Serum creatinine >/= 30 ml/min/1.73 m² according to the MDRD (Modified Diet in Renal Disease)
abbreviated formula, Lipase
- Left Ventricular Ejection Fraction (LVEF) >/= 50 % as assessed at the Baseline
Multigated Acquisition (MUGA) scan

- QTc (Q-T corrected)
- Having advanced, refractory disease

- Life expectancy of at least 3 months

- Recovery from any previous drug/procedure-related toxicity to Common Toxicological
Criteria (CTC) Grade 0 or 1 levels (except alopecia), or to baseline preceding the
prior treatment.

Exclusion Criteria:

- History of cardiac disease: congestive heart failure > New York Heart Association
(NYHA) Class II; active coronary artery disease (unstable angina [anginal symptoms at
rest] or new-onset angina [began within the last 3 months] or myocardial infarction
within the past 6 months).

- Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg,
despite the use of >/= 3 antihypertensive drugs or systolic blood pressure greater
than 150 mmHg)

- History of or known human immunodeficiency virus (HIV) infection or active hepatitis
B or C.

- Subjects with serious non-healing wound, ulcer, or bone fracture

- Subjects with arterial or venous thrombotic or embolic events such as cerebrovascular
accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary
embolism within the 6 months before start of study medication

- Persistent proteinuria of CTC Grade 3 or higher (> 3.5 g/24 hours, measured by urine
protein/creatinine ratio on a random urine sample)

- Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months
from definitive therapy, has no evidence of tumor growth on an imaging study within 2
weeks prior to study entry, and is clinically stable with respect to the tumor at the
time of study entry

- Clinically significant bleeding (CTC AE Grade 3 or higher) within 30 days before
start of study medication.

- Subjects with seizure disorder requiring anticonvulsant medication

- History of organ allograft