A Phase I, Multi-center, Non-randomized, Open Label, Parallel-group Study Evaluating the Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Subjects With Severe Renal Impairment Compared to a Control Group
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
- For subjects with NORMAL OR MILDLY IMPAIRED RENAL FUNCTION (Control group); to be
tested within 7 days of starting the study treatment:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- 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