EVALUATION OF THE EFFECTIVENESS OF AXITINIB IN PATIENT WITH HEPATOCELLULAR CARCINOMA PROGRESSED WITH SORAFENIB

• Conditions: Hepatocellular carcinoma (HCC); MedDRA version: 15.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002029-24-IT
• Lead Sponsor: IVERSITA' CAMPUS BIOMEDICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-27
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <= 2 ? Life expectancy >= 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 <2+ by urine dipstick. If dipstick is = 2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours. ? Adequate coagulation function ? No evidence of pre-existing uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be ?140 mm Hg, and the baseline diastolic blood pressure readings must be ?90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible ? Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment ? Written informed consent ? Minimum of 4 weeks since any local procedures (chemoembolizzation or termoablation) or completion of radiation ? Minimum of 4 weeks since completion of all prior systemic anticancer therapy ? written informed consent approval by the institutional review board at each institution
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified