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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00901901




Registration number
NCT00901901
Ethics application status
Date submitted
13/05/2009
Date registered
14/05/2009
Date last updated
30/05/2019

Titles & IDs
Public title
Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
Scientific title
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)
Secondary ID [1] 0 0
2008-006021-14
Secondary ID [2] 0 0
12917
Universal Trial Number (UTN)
Trial acronym
SEARCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sorafenib (Nexavar, BAY43-9006)
Treatment: Drugs - Erlotinib (Tarceva)
Treatment: Drugs - Placebo

Experimental: Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) - Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)

Active Comparator: Sorafenib (Nexavar, BAY43-9006) + Placebo - Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)


Treatment: Drugs: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg twice daily

Treatment: Drugs: Erlotinib (Tarceva)
Erlotinib 150 mg once daily

Treatment: Drugs: Placebo
Matching erlotinib placebo 150 mg once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization of the first patient until 34 months or date of death of any cause whichever came first
Secondary outcome [1] 0 0
Time to Radiological Tumor Progression (TTP)
Timepoint [1] 0 0
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Secondary outcome [2] 0 0
Disease Control
Timepoint [2] 0 0
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Secondary outcome [3] 0 0
Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index
Timepoint [3] 0 0
The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.
Secondary outcome [4] 0 0
Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS
Timepoint [4] 0 0
The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.

Eligibility
Key inclusion criteria
- Patients > 18 years of age

- Patients who have a life expectancy of at least 12 weeks

- Patients with histological or cytologically documented HCC

- Patients must have at least one tumor lesion that meets both of the following
criteria:

- The lesion can be accurately measured in at least one dimension according to
response evaluation criteria in solid tumors (RECIST)

- The lesion has not been previously treated with local therapy

- Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status)
of 0 or 1

- Cirrhotic status of Child-Pugh class A.

- Patients who give written informed consent prior to any study specific screening
procedures with the understanding that the patient has the right to withdraw from the
study at any time.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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).

- History of interstitial lung disease (ILD).

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

- Previous treatment with yttrium-90 spheres

- Any condition that is unstable or which could jeopardize the safety of the patient and
his/her compliance in the study.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/05/2018
Sample size
Target
Accrual to date
Final
732
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Herston
Recruitment hospital [4] 0 0
- Clayton
Recruitment hospital [5] 0 0
- Melbourne
Recruitment hospital [6] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4120 - Brisbane
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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California
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District of Columbia
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Florida
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Georgia
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Hawaii
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Illinois
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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North Carolina
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Washington
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Austria
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Wien
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Bruxelles - Brussel
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Belgium
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Edegem
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Gent
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Kortrijk
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La Louviere
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Leuven
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Liege
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Sao Paulo
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Rio de Janeiro
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Bulgaria
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Plovdiv
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Sofia
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Varna
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Canada
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Alberta
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Quebec
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Chile
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Santiago
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Jiangsu
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Zhejiang
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Beijing
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Clichy
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Creteil
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France
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La Roche Sur Yon
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Lille
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Lyon
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Vandoeuvre-les-nancy
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Villejuif
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Baden-Württemberg
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Bayern
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Germany
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Hessen
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Niedersachsen
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Shatin
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Haifa
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Israel
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Rehovot
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Barnaul
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Moscow
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Singapore
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Singapore
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Gauteng
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Barcelona
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Lugo
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Madrid
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Santander
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Spain
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Valencia
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Tainan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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South Yorkshire
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Glasgow
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London
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United Kingdom
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Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily
and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib
once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients
who are candidates for potentially curative intervention (i.e. surgical resection or local
ablation) are not eligible for this study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00901901
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00901901