Clinical trial · Interventional
Open Label Regorafenib Study to Evaluate Cardiovascular Safety Parameters, Tolerability, and Anti-tumor Activity
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
NCT01339104CI-TRIAL-00015739completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Open label Phase I study of Regorafenib to evaluate cardiovascular safety, tolerability and anti-tumor activity in patients with advanced solid tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Regorafenib
- interventionNames
- Drug: Regorafenib (Stivarga, BAY73-4506)
Primary outcomes (2)
- measure
- Effect of regorafenib on cardiovascular safety parameters measured by change in QT\QTc on the ECG in patients with advanced solid tumors
- timeFrame
- After 8 weeks
- measure
- Effect on Left Ventricular Ejection Fraction (LVEF)
- timeFrame
- 12 weeks post Cycle 1
Secondary outcomes (1)
- measure
- Decrease in tumor size based on investigator assessed RECIST criteria
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJones RL, Bendell JC, Smith DC, Diefenbach K, Lettieri J, Boix O, Lockhart AC, O'Bryant C, Moore KN. A phase I open-label trial evaluating the cardiovascular safety of regorafenib in patients with advanced cancer. Cancer Chemother Pharmacol. 2015 Oct;76(4):777-84. doi: 10.1007/s00280-015-2827-3. Epub 2015 Aug 18. PMID 26281907