Study of Sorafenib With or Without VT-122 in Patients With Hepatocellular Carcinoma (HCC)

• Status: Unknown status
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if VT-122 provides a clinical benefit when added to Sorafenib in patients with advanced hepatocellular carcinoma (HCC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vicus Therapeutics
• Treatments: Etodolac; Niacinamide; Propranolol; Sorafenib

Criteria

Inclusion Criteria:

Participants will be required to meet all of the following criteria to be considered eligible for the study:

• Have a confirmed diagnosis of HCC. Biopsy is preferred but is not required.

• Male and female participants who are ≥18 years of age.

• In the opinion of the investigator, the participants have a life expectancy of at least 12 weeks.

• Able to take food or nutritional support orally.

• On sorafenib for at least 4 weeks prior to randomization. Dose adjustments are allowed prior to randomization.

• Have a Karnofsky Performance Score (KPS) equal to or greater than 50.

• Have a cirrhotic status of Child-Pugh Class A or B7.

• Have the following laboratory parameters:

• a. Platelet count ≥50 x 10E9/L.

• b. Total bilirubin ≤1.5 mg/dL (≤1.0 mg/dL for primary biliary cirrhosis). If total bilirubin >1.5 mg/dL but <3.0 mg/dL, a patient could be enrolled after consultation with the Medical Monitor. If total bilirubin is >3.0 mg/dL, but the value has been constant for a period of greater than 3 months, a patient could be enrolled after consultation with the Medical Monitor.

• c. Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance >60 mL/min calculated using Cockcroft-Gault.

• d. Serum albumin ≤3.5 g/dL and/or C-reactive protein (CRP) ≥3 mg/L

• Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice.

Exclusion Criteria:

Participants must not have any of the following criteria to be considered eligible for inclusion in the study:

• The patient has a history of another primary cancer, with the exception of: a) curatively resected non-melanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor with no known active disease present that in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.

• Contraindication to sorafenib, propranolol, etodolac, or placebo.

• Patient currently on beta-blockers for the treatment of portal hypertension or arrhythmia. [Patients on beta blockers for the treatment of hypertension are allowed if they change to a different drug class, e.g. some classes of angiotensin-converting enzyme (ACE) inhibitors, for controlling hypertension at least one week before randomization].

• Body mass index (BMI) <17.5 kg/m2.

• History or evidence of cardiac disease: congestive heart failure; New York Heart Association class 2 or greater; active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrioventricular block of second or third degree, or uncontrolled hypertension. Patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization.

• Hypotension at the time of screening (i.e., systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg).

• Resting heart rate <60 bpm at time of screening.

• Participants with a recent diagnosis of bleeding varices that has not been resolved for a minimum period of 4 weeks.

• Any uncontrolled intercurrent illness that, in the opinion of the Investigator, may interfere with study evaluation.

• On chronotropic drugs (acetylcholine, digoxin, diltiazem, verapamil, atropine, dopamine, dobutamine, epinephrine, isoproterenol).

• Active clinically serious infections [>Grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0].

• Known history of human immunodeficiency virus (HIV) infection.

• Known central nervous system tumors including metastatic brain disease.

• Clinically significant gastrointestinal (GI) bleeding within 30 days prior to Screening.

• Substance abuse, medical, psychological or social conditions that may, in the in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results.

• Known or suspected allergy to the investigational agents or any agent given in association with this trial (hypersensitivity reaction, hives, rash, difficulty breathing swelling of face, lips, tongue, or throat).

• Inability to swallow oral medications.

• Any condition that is unstable or which in the opinion of the Investigator could jeopardize the safety of the patient and his/her compliance in the study.

• Pregnant or breastfeeding participants. Women of childbearing potential (non-childbearing potential is defined as menopausal for at least 2 years, post-bilateral tubal ligation for at least 1 year, post-bilateral oophorectomy or post-hysterectomy) must have a negative urine pregnancy test performed within 10 days prior to the start of study drug. Both men and women enrolled in this trial must use adequate double-barrier birth control measures [2 types of an acceptable form of FDA-approved contraception (e.g., barrier method, Depo-Provera™, Norplant™, Ortho Evra® [birth control patch], oral contraceptives)] during the course of the trial.

• Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study.