Study Completed

Neoplasms

Bayer Identifier:

14814

ClinicalTrials.gov Identifier:

NCT01339104

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

Open label Phase I study of Regorafenib to evaluate cardiovascular safety, tolerability and anti-tumor activity in patients with advanced solid tumors

Key Participants Requirements

Sex

Both

Age

18 - N/A

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 -- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) /= 30 ml/min/1.73 m² according to the MDRD (Modified Diet in Renal Disease) abbreviated formula, Lipase -- Left Ventricular Ejection Fraction (LVEF) >/= 50 % as assessed at the Baseline Multigated Acquisition (MUGA) scan
-- QTc (Q-T corrected) - 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

Trial Dates

April 2011 - August 2013

Phase

Phase 1

Could I Receive a placebo

Products

Stivarga (Regorafenib, BAY73-4506)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Sarah Cannon Cancer Center	Nashville, 37203, United States
Completed	Seattle Cancer Center Alliance	Seattle, 98109, United States
Completed	University of Michigan Health System	Ann Arbor, 48109, United States
Completed	Washington University School of Medicine	St. Louis, 63110, United States
Completed	University of Colorado Hospital	Aurora, 80010, United States
Completed	Oklahoma University Health Science Center	Oklahoma City, 73104, United States

Primary Outcome

Effect of regorafenib on cardiovascular safety parameters measured by change in QT\QTc on the ECG in patients with advanced solid tumors
Time Frame:
After 8 weeks
Safety Issue:
Yes
Effect on Left Ventricular Ejection Fraction (LVEF)
Time Frame:
12 weeks post Cycle 1
Safety Issue:
Yes

Secondary Outcome

Decrease in tumor size based on investigator assessed RECIST criteria
Time Frame:
3 years
Safety Issue:
Yes

Trial design

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

Additional Information

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