Trial Condition(s):

Neoplasms

Open label Regorafenib study to evaluate cardiovascular safety parameters, tolerability, and anti-tumor activity

Bayer Identifier:

14814

ClinicalTrials.gov Identifier:

NCT01339104

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Open label Phase I study of Regorafenib to evaluate cardiovascular safety, tolerability 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 </= 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.
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

Trial Summary

Enrollment Goal
53
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Sarah Cannon Cancer Center

Nashville, United States, 37203

Status
Completed
 
Locations

Seattle Cancer Center Alliance

Seattle, United States, 98109

Status
Completed
 
Locations

University of Michigan Health System

Ann Arbor, United States, 48109

Status
Completed
 
Locations

Washington University School of Medicine

St. Louis, United States, 63110

Status
Completed
 
Locations

University of Colorado Hospital

Aurora, United States, 80010

Status
Completed
 
Locations

Oklahoma University Health Science Center

Oklahoma City, United States, 73104

Status
Completed
 

Trial Design