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: 19.0 Level: LLT Classification code 10019829 Term: Hepatocellular carcinoma recurrent System Organ Class: 100000004864
MedDRA version: 19.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2008-006021-14-DE

Lead Sponsor: Bayer AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 720

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 ctyological 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 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. Myocardial infarction more than 6 months prior to study entry is permitted. (See Appendix 10.7)

•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

Primary Outcome Measures

Name	Time	Method
Main Objective: Overall Survival;<br> Secondary Objective: Time to radiographic Tumor Progression (TTP)<br> <br> Disease Control Rate (DCR)<br> <br> Safety<br> <br> Health Related Quality of Life (HRQoL) and utility values as measured by EQ-5D<br> ;Primary end point(s): Overall Survival measured via patient phone contacts after treatment is complete;Timepoint(s) of evaluation of this end point: From the date of randomisation until the date of death due any cause

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Time to progression, response rate, duration of response, disease control rate, determind by tumor measurment using MRI or CT scans<br> 2. Health-related quality of life and utility values as measured by EQ-5D<br> 3. Safety<br> ;<br> Timepoint(s) of evaluation of this end point: 1. Every 6 weeks during treatment<br> 2. Every 6 weeks during treatment<br> 3. Every 3 weeks during treatment<br> <br>

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