Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 February 2019 |
Main ID: |
EUCTR2008-006021-14-GB |
Date of registration:
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08/05/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Evaluation of the combination of Nexavar and Tarceva for the treatment of liver cancer.
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Scientific title:
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A Phase III randomized, placebo controlled, double blind trial of Sorafenib plus Erlotinib vs. Sorafenib plus placebo as First Line systemic treatment for Hepatocellular Carcinoma (HCC) - SEARCH |
Date of first enrolment:
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03/06/2009 |
Target sample size:
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700 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006021-14 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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Chile
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China
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Colombia
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France
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Germany
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Greece
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Hong Kong
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Israel
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Italy
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Korea, Democratic People's Republic of
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New Zealand
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Peru
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Poland
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Russian Federation
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Singapore
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South Africa
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Spain
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Bayer Clin. Trials Contact CTP Team
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Address:
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Bayer Pharma AG, S102, Level 2, Room 156
13342
Berlin
Germany |
Telephone:
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Email:
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clinical-trials-contact@bayerhealthcare.com |
Affiliation:
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Bayer |
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Name:
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Bayer Clin. Trials Contact CTP Team
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Address:
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Bayer Pharma AG, S102, Level 2, Room 156
13342
Berlin
Germany |
Telephone:
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Email:
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clinical-trials-contact@bayerhealthcare.com |
Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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 lesion 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 therapy 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 ratio (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 = 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 >90mmHg 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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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To evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 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
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Trade Name: NEXAVAR Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sorafenib CAS Number: 284461-73-0 Current Sponsor code: BAY 43-9006 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
Trade Name: TARCEVA Pharmaceutical Form: Film-coated tablet INN or Proposed INN: erlotinib CAS Number: 183321-74-6 Current Sponsor code: Ro-508231 Other descriptive name: erlotinib hydrochloride Concentration unit: mg milligram(s) Concentration type: range Concentration number: 25 mg-150 mg Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: From the date of randomisation until the date of death due to any cause
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Primary end point(s): Overall Survival measured via patient phone contacts after treatment is complete
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Main Objective: Overall Survival
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Secondary Objective: Time to radiographic Tumor Progression (TTP)
Disease Control Rate (DCR)
Safety
Health Related Quality of Life (HRQoL) and utility values as measured by EQ-5D
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1. Every 6 weeks during treatment
2. Every 6 weeks during treatment
3. Every 3 weeks during treatment
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Secondary end point(s): 1. Time to progression, response rate, duration of response, disease control rate, determined by tumor measurement using MRI or CT scans
2. Health-related quality of life and utility values as measured by the EQ-5D
3. Safety
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Secondary ID(s)
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BAY43-9006/12917
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2008-006021-14-DE
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Source(s) of Monetary Support
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Bayer AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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