check_circleStudy 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
  • - 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.
  • - 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
April 2011 - August 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sarah Cannon Cancer CenterNashville, 37203, United States
Completed
Seattle Cancer Center AllianceSeattle, 98109, United States
Completed
University of Michigan Health SystemAnn Arbor, 48109, United States
Completed
Washington University School of MedicineSt. Louis, 63110, United States
Completed
University of Colorado HospitalAurora, 80010, United States
Completed
Oklahoma University Health Science CenterOklahoma 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
    date_rangeTime Frame:
    After 8 weeks
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    Safety Issue:
    Yes
  • Effect on Left Ventricular Ejection Fraction (LVEF)
    date_rangeTime Frame:
    12 weeks post Cycle 1
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Decrease in tumor size based on investigator assessed RECIST criteria
    date_rangeTime Frame:
    3 years
    enhanced_encryption
    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
1

Additional Information

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