check_circleStudy Completed
Neoplasms
Bayer Identifier:
14814
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
53Trial Dates
April 2011 - August 2013Phase
Phase 1Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere 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 tumorsdate_rangeTime Frame:After 8 weeksenhanced_encryptionYesSafety Issue:
- Effect on Left Ventricular Ejection Fraction (LVEF)date_rangeTime Frame:12 weeks post Cycle 1enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Decrease in tumor size based on investigator assessed RECIST criteriadate_rangeTime Frame:3 yearsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1