Trial Condition(s):
Open label Regorafenib study to evaluate cardiovascular safety parameters, tolerability, and anti-tumor activity
14814
Not Available
Not Available
Open label Phase I study of Regorafenib to evaluate cardiovascular safety, tolerability and anti-tumor activity in patients with advanced solid tumors
- 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 </= 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.
- 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
Locations | |
---|---|
Locations Sarah Cannon Cancer Center Nashville, United States, 37203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seattle Cancer Center Alliance Seattle, United States, 98109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Michigan Health System Ann Arbor, United States, 48109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Washington University School of Medicine St. Louis, United States, 63110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Colorado Hospital Aurora, United States, 80010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oklahoma University Health Science Center Oklahoma City, United States, 73104 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1