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Complete title: An Open-label, non-randomized Phase 1 study of Regorafenib (BAY 73-4506) to evaluate cardiovascular safety, tolerability, pharmacokinetics and anti-tumor activity in patients with Advanced Solid Tumors
|Research Study Number||20110500|
|Principal Investigator||Robin Jones|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
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 </= 1.5 times upper limit of normal (ULN), Alkaline phosphatase </= 4 x ULN
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) </= 2.5 times ULN (</= 5.0 x ULN for subjects with liver involvement of their cancer), International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) < 1.5 x ULN, Serum creatinine </= 1.5 times ULN and glomerular filtration rate (GFR) >/= 30 ml/min/1.73 m² according to the MDRD (Modified Diet in Renal Disease) abbreviated formula, Lipase </= 1.5 x ULN
- Left Ventricular Ejection Fraction (LVEF) >/= 50 % as assessed at the Baseline Multigated Acquisition (MUGA) scan
- QTc (Q-T corrected) </= 470 msec at Screening
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.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
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
Other exclusion criteria may apply.
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