Optimization for Regorafenib in HCC

Stopped early · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

This is a randomized, two arm, phase II study of 1st Cycle dose optimization for regorafenib treatment compared to standard dose of regorafenib treatment in HCC patients for whom the physician is intending to treat with regorafenib and who failed any 1st line systemic treatment.

Key facts

Study ID

NCT04476329

Run by

SC Liver Research Consortium, LLC

People needed

7

Starts

2021-01-21

Expected to finish

2021-12-10

Last updated by the study team

2021-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients age ≥ 18 years.
• Histological, cytological confirmation of hepatocellular carcinoma or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in patients with a confirmed diagnosis of cirrhosis.
• Locally advanced or metastatic and/or unresectable HCC that is not amenable or progressed after curative surgical and/or locoregional therapies.
• Patients who received one prior systemic treatment and for whom the treating physician has decided to treat with regorafenib.
• Life expectancy of ≥ 3 months.
• The following laboratory values obtained ≤ 7 days prior to randomization.
• Absolute neutrophil count (ANC) > 1500/mm3
• Platelet count > 60,000/mm3
• Hemoglobin > 9.0 g/dL
• Albumin > 2.7 gm/dL
• Total bilirubin < 2 mg/dl (Mildly elevated total bilirubin (< 6 mg/dL) is allowed if Gilbert's syndrome is documented)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x ULN
• Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 50 mL/min (calculated using the Cockcroft-Gault formula)
• INR/PTT ≤ 1.5 x ULN
• Alkaline phosphatase limit ≤ 2.5 x ULN
• At least one measurable (per RECIST 1.1) lesion. Patients who received prior local therapy (e.g., radiofrequency ablation or transarterial chemoembolization, etc.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) = 0 or 1
• Negative serum pregnancy test done ≤ 7 days prior to randomization, for females of childbearing potential only.
• Provide written informed consent.
• Patients with a prior liver transplant may be included if they have no history of graft rejection within the previous 6 months and stable graft function.

You may not qualify if…

• Prior treatment with regorafenib.
• Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to randomization.
• Congestive heart failure > New York Heart Association (NYHA) class 2.
• Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction less than 6 months prior to randomization.
• Cardiac arrhythmias requiring anti-arrhythmic therapy. Note: beta blockers or digoxin are permitted.
• Uncontrolled hypertension. (Systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
• History of or current pheochromocytoma.
• Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism ≤ 6 months prior to randomization.
• Ongoing infection > grade 2 NCI-CTCAE version 5.0.
• Patients with seizure disorder requiring medication.
• Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of randomization and is clinically stable with respect to the tumor at the time of randomization.
• NOTE: Patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
• History of organ allograft (including corneal transplant), except prior liver transplant.
• Hepatic Encephalopathy requiring hospital admission within six (6) months prior to randomization.
• Ascites requiring paracentesis within four (4) weeks of randomization.
• Evidence or history of bleeding diathesis or any hemorrhage or bleeding event > CTCAE grade 3 ≤4 weeks prior to randomization.
• Non-healing wound, ulcer, or bone fracture.
• Renal failure requiring hemo-or peritoneal dialysis.
• Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
• Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
• Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
• Persistent proteinuria of CTC Grade 3 or higher (> 3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample).
• Patients unable to swallow oral medications.
• Any malabsorption conditions that will affect that absorption of regorafenib.
• Unresolved toxicity greater than CTCAE (version 5.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity ≤ Grade 2.

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• VA Long Beach Health System — Long Beach, California, United States
• Tulane University — New Orleans, Louisiana, United States
• Henry Ford Health Systems — Detroit, Michigan, United States
• Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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