A study comparing E7050 and Sorafenib to Sorafenib alone for thetreatment of liver cancer.

• Conditions: Hepatocellular carcinoma; MedDRA version: 14.1Level: LLTClassification code 10049010Term: Carcinoma hepatocellularSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000752-41-IT
• Lead Sponsor: EISAI LTD UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. Male or female patient = 18 years of age;2.Histologically or cytologically confirmed, unresectable locally advanced or metastatic HCC. Patients with HCC may be enrolled without histological confirmation of disease so long as they meet the following criteria for diagnosis of HCC (and all other protocol eligibility criteria):Lesion >2 cm in diameter, AND Serum a-fetoprotein (AFP) =400 ng/mL (if serum AFP is <400 ng/mL,a biopsy is required to confirm HCC); AND Radiological appearance of mass is suggestive of HCC (ie, contrast enhanced CT or MRI with arterial hypervascularity AND venous or delayed phase washout); 3.No previous prior systemic anti-cancer therapy (1 prior systemic anticancer regimen is allowed in Phase 1b);4. At least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v. 1.1) criteria. Tumor lesions previously treated with local therapy should demonstrate clear dimensional increase by radiographic assessment in order to be selected as target lesion(s) at Baseline;5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)0 or 1;6 Child-Pugh Cirrhotic Status A or B with a score of 7;7. For patients with hypertension, it must be well controlled. If a patient presents with poorly controlled hypertension, defined as a mean systolic blood pressure =140 mm Hg or mean diastolic blood pressure =90 mm Hg, antihypertensive medication(s) should be initiated or adjusted with a goal to control the blood pressure <140/90 mm Hg. Blood pressure must be reassessed on 2 occasions, consecutively, that are separated by a minimum of 24 hours;8.Patients must have adequate liver function as evidenced by bilirubin = 2.0 mg/dL and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) =5 times the upper limit of the normal range (ULN). If there are bone metastases, liver-specific alkaline phosphatase (gamma-glutamyltransferase) may be separated from the total and used to assess liver function instead of total alkaline phosphatase; 9.International normalized ratio (INR) 0.8 to 1.4 or =3 for patients receiving vitamin K antagonists; 10. Patients must have adequate renal function as evidenced by:Serum creatinine =1.5 X ULN and creatinine clearance >50 mL/min per the Cockcroft and Gault formula; Urine protein creatinine (UPC) ratio of <1 on a spot urine or <1.0 g of protein determined by 24-hour urine protein analysis. If the UPC ratio is =1, 24-hour urine protein must be assessed and the 24- hour urine protein must be <1.0 g of protein for the patient to be eligible;11. Patients must have adequate bone marrow function as evidenced by an absolute neutrophil count (ANC) =1.5 X 109/L, hemoglobin =9.0 g/dL(a hemoglobin <9.0 g/dL at Screening is acceptable if it is corrected to = 9 g/dL by growth factor or transfusion prior to the first dose), and platelet count =60 X 109/L; 12. Male or female patients of childbearing potential must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment; 13. Females of childbearing potential must have a negative serum pregnancy test at Screening;14. Females may not be breastfeeding;15. Ability to understand and willingness to sign a written informed consent.
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 r

Exclusion Criteria

1. Prior treatment with E7050, its chemical derivatives or prior anti-c- Met therapy;2. Prior anti-angiogenic therapy (permitted in Phase Ib); 3. Prior systemic anti-cancer therapy (one prior systemic anti-cancer therapy is allowed for the Phase 1b portion of the study, must not be within 4 weeks prior to first day of study-defined treatment); 4. Prior external beam radiation to the primary site;5. Prior central thoracic radiation therapy, including to the heart;6. Previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies within 6 weeks prior to the first day of study-defined treatment; 7. Child-Pugh Cirrhotic Status >7; 8. History of other malignancies except: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, or b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for =3 years; 9. Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization; 10. Received treatment in another clinical study within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to Grade =1, except for peripheral neuropathy (Grade 1 and Grade 2 are permitted) and alopecia; 11. Palliative radiotherapy is not permitted throughout the study period;12. Common Terminology Criteria (CTC) Grade =3 peripheral neuropathy (Grade 1 and Grade 2 are permitted); 13. Active clinically serious infections defined as Grade =3 according to CTCAE v. 4.0; 14. Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within the 28 days prior to commencing study treatment. Minor surgery such as core biopsy or Portacath placement or skin biopsy is permitted if =7 days have passed; 15. History of bleeding diathesis or coagulopathy other than due to anticoagulation therapy; 16. History of bleeding varices; 17. Active hemoptysis (defined as bright red blood of ½ teaspoon or more) within the 30 days prior to study entry; 18. Clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention, eg. variceal banding, transjugular intrahepatic portosystemic shunt procedure, arterial embolization, topical coagulation therapy) within 6 months prior to first dose;19. History of untreated deep venous thrombosis within the past 6 months (eg, calf vein thrombosis); 20. Refractory nausea and vomiting, malabsorption, significant bowel resection with clinical evidence of malabsorption, or any other medical condition that would preclude adequate absorption or result in the inability to take oral medication;21. Significant cardiovascular impairment (history of congestive heart failure New York Heart Association [NYHA] Grade >2, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia); 22. Known positive human immunodeficiency virus (HIV); 23. Have anymedical condition that would interfere with the conduct of the study.

Study & Design

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