Evaluation of the combination of Nexavar and Tarceva for the treatment of liver cancer.

Phase 1

• Conditions: To evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotibib 150 mg once a day in subjects with unresectable advanced or metastatic Child-Pugh A HCC.; MedDRA version: 13.1Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-006021-14-AT
• Lead Sponsor: Bayer HealthCare AG, 51368 Leverkusen, Germany

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-13
• Last Update Posted: 3 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

•Patients with histological or cytologically documented HCC or clinical diagnosis by AASLD criteria in cirrhotic subjects is required. For subjects without cirrhosis histological or cytological confirmation is necessary.

•Patients must have at least one tumor lesions that meets both of the following criteria:
- Lesion can be accurately measured in at least one dimension according to RECIST
- Lesion has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation

•Patients who have received local therapy are eligible. Local theapy must be completed at least 4 weeks prior to the baseline scan. Previously treated lesions will not be selected as target lesions.

•Patients with an ECOG PS of 0 or 1.

•Cirrhotic status of Child-Pugh Class A.

•Following Laboratory Parameters (as assessed by Central Laboratory):
- Platelet count = 60 x 109/L
- Hemoglobin = to 8.5 g/dl
- Total Bilirubin = 2.8 mg/dl
- ALT and AST = 5 x ULN
- Serum Creatinine = 1.5 x ULN
- PT international normalized ration (INR) = 2.3 or PT = 6 seconds above control
- Patients who are being therapeutically anticoagulated with an agent such as wafarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists and these patients have a Child-Pugh score = 6 during screening.

•Patients must provide written informed consent prior to any study procedures being performed

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Renal failure requiring hemo- or peritoneal dialysis

•Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) – related illness or serious acute or chronic illness.

•Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sogren’s syndrome) including congenital abnormality (e.g. Fuch’s dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test).

•Child-Pugh class B or C

•Previous treatment with yttrium- 90 spheres

•Clinically significant (i.e. symptomatic) peripheral vascular disease

•History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension defined as systolic blood pressure>150mmHg or diastolic blood pressure>90 mmHg despite optimal medical management. Myocardial infarction more than 6 months prior to study entry is permitted. (See Appendix 11.6)

•History of interstitial lung disease (ILD)

•Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

•Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), except HBV/HCV infections

•Uncontrolled ascites (defined as not easily controlled with diuretic treatment)

•Pregnant or breast-feeding patients.

Study & Design

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