Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment

Inclusion Criteria:

Subjects with histologically confirmed, locally advanced or metastatic, refractory solid tumors who are not candidates for standard therapy
Male or female subject ≥ 18 years of age
Women of childbearing potential must have a negative urine pregnancy test performed within 7 days before start of study treatment
Life expectancy at least 8 weeks
Adequate bone marrow, and liver function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

For subjects with NORMAL OR MILDLY IMPAIRED RENAL FUNCTION (Control group); to be tested within 7 days of starting the study treatment:

Estimated creatinine clearance (CLcr) ≥ 60 mL/min as calculated using the Cockcroft-Gault equation

For subjects with SEVERELY IMPAIRED renal function; to be tested within 7 days of starting the study treatment:

CLcr 15-29 mL/min as calculated using the Cockcroft-Gault equation

Exclusion Criteria:

Symptomatic metastatic brain or meningeal tumors
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
History of organ allograft
Non-healing wound, skin ulcer, or bone fracture
Pheochromocytoma
Uncontrolled concurrent medical illness including uncontrolled hypertension
History of cardiac disease
Pleural effusion or ascites that causes respiratory compromise
Interstitial lung disease with ongoing signs and symptoms at the time of screening
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication
Subjects with evidence or history of bleeding diathesis; any hemorrhage or bleeding event NCI-CTCAE Grade ≥ 3 or higher within 4 weeks of start of investigational treatment
Dehydration NCI-CTCAEversion 4.0 Grade ≥ 1
Unresolved toxicity higher than NCI-CTCAE version 4.0 Grade 1 attributed to any prior therapy/procedure (excluding alopecia or anemia or grade 2 neuropathy that is not reversible due to oxaliplatin)
Seizure disorder requiring anticonvulsant therapy (such as steroids or anti-epileptics)

For subjects with SEVERELY IMPAIRED renal function:

Renal failure requiring hemo- or peritoneal dialysis
Acute renal failure
Acute nephritis
Nephrotic syndrome