Hepatocellular carcinoma (HCC) MedDRA version: 15.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: AXITINIB
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: AXITINIB
CAS Number: NA
Current Sponsor code: AG-013736
Other descriptive name: NA
Concentration unit: mg milli
Sponsors
UNIVERSITA' CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Histologically or cytologically proven HCC or alpha-fetoprotein level > 400 ng/ml together with hypervascular tumor and cirrhosis documented by CT scan or MRI. BCLC criteria 2000 ? HCC not amenable to curative treatment (resection, transplantation, percutaneous ablation) ? prior systemic treatment for HCC with sorafenib ? Presence of at least one dimensionally measurable target lesion with largest diameter >= 2 cm. ? World Health Organization (WHO) performance status = 12 weeks. ? Age >= 18 years. ? Child Pugh score A ? Adequate hematologic functions (neutrophil count = 1500 per cubic millimeter; platelet count = 75,000 per cubic millimetre; Hemoglobin = 9 g/dl) ? Adequate liver function (bilirubin = 1.5 the upper limit of normal; AST and ALT = 2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT = 5.0 x ULN) ? Adequate renal function (serum creatinine ?1.5 x ULN or calculated creatinine clearance = 60 mL/min) ? Urinary protein =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: ? Decompensated cirrhosis (Child-Pugh score > 7) ? Variceal bleeding during the previous 3 months ? Gastrointestinal abnormalities including: History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment, inability to take oral medication, requirement for intravenous alimentation, prior surgical procedures affecting absorption including total gastric resection, treatment for active peptic ulcer disease in the past 6 months, active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy, malabsorption syndromes. ? Thromboembolic event during the previous 6 months, except for portal vein neoplastic thrombosis ? Current or anticipated use of drugs known to be potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine). ? Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John’s wort). ? Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed. ? Abnormal cardiac function with history of ischemic heart disease in the previous 6 months, uncontrolled hypertension, unstable angina, severe cardiac arrhythmia ? Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry. ? Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. ? Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. ? Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis. ? Previous or current malignancies at other sites ? Concomitant antitumor treatment including tamoxifen or somatostatin analogs. ? Unstable systemic diseases or active uncontrolled infections. ? Female patients who are pregnant or lactating, or men and women of reproductive potential not willing or not able to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for 6 months after discontinuing study treatment The definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate. ? Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug. ? Serious or non-healing wound, ulcer, or bone fracture. ? Uncontrolled Hypertension ? Class III or IV heart failure as defined by the NYHA functional classification system. ? Patients with thyroid abnormality not in cure. ? Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study. ? Other concurrent chemotherapy, immunotherapy, radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: explore the clinical activity of Axitinib in patients affected by locally advanced, unresectable, metastatic hepatocellular carcinoma progressed under treatment or intolerant to sorafenib.;Secondary Objective: To assess the duration of response (first administration of study drug until PD in patients with objective responses);Primary end point(s): To assess rate of patients without progression;Timepoint(s) of evaluation of this end point: 4 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) To estimate disease control rate (proportion of patients with best response of CR+PR+SD) 2) to estimate overall survival (first day of receiving study medication to death) 3) To define safety/toxicity profile;Timepoint(s) of evaluation of this end point: 4 months | — |
Countries
Italy
Contacts
Public ContactONCOLOGIA MEDICA
UNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
Outcome results
None listed