Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT00576056
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with HCC seen at UPMC will be enrolled in this study if they meet the following eligibility criteria:
* Adults patients (≥ 18 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
* Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP \> 200
* Patient must have quantifiable disease limited to the liver
* Patients must have at least one tumor lesion that meets both of the following criteria:
* The lesion can be accurately measured in at least one dimension according to RECIST criteria
* The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
* ECOG performance status (PS) \<2
* No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
* At least 4 weeks since prior TACE
* At least 4 weeks since prior interferon
* Not pregnant
* No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
* No significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis
* No current infections requiring antibiotic therapy
* Not on anticoagulation or suffering from a known bleeding disorder
* No unstable coronary artery disease or recent MI
* The following laboratory parameters:
* Platelet count ≥ 60,000/µL
* Hemoglobin ≥ 8.5 g/dL
* Total bilirubin ≤ 1.5 mg/dL
* ASL and AST ≤ 5 x upper limit of normal
* Serum creatinine ≤ 1.5 x upper limit of normal
* INR ≤ 1.5 or a Pt/PTT within normal limits
* Absolute neutrophil count (ANC) \> 1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria:
* Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), and any cancer curatively treated \> 3 years prior to entry is permitted
* Renal failure requiring hemo- or peritoneal dialysis
* Child-Pugh B \& C hepatic impairment
* History of cardiac disease: \> NY Heart Association (NYHA) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
* Active clinically serious infections (\> CTCAEv3 grade 2)
* Known history of HIV
* Known central nervous system tumors including metastatic brain disease
* History of organ allograft
* Substance abuse (current), psychological, or social conditions that may 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.
* Patients unable to swallow oral medications.
* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg, despite optimal medical management
* Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
* Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
* Serious non-healing wound, ulcer, or bone fracture
Excluded therapies and medications, previous and concomitant:
* Prior use of Raf-kinase inhibitors (RKI), VEGF inhibitors, MEK inhibitors, or farnesyl transferase inhibitors
* Major surgery within 6 weeks of start of study drug
* Radiotherapy during study or within 3 weeks prior to start of study drug.
* Use of biologic response modifiers such as granulocyte colony-stimulating factor (G-CSF) within 3 weeks prior to study entry.
* Autologous bone marrow transplant or stem cell rescue within four months of study drug initiation
* Concomitant treatment with rifampin or St. John's wort.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT00576056
Study Brief:
Protocol Section:
NCT00576056