Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Austria
State/province [19] 0 0
Wien
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles - Brussel
Country [21] 0 0
Belgium
State/province [21] 0 0
Edegem
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
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Belgium
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Kortrijk
Country [24] 0 0
Belgium
State/province [24] 0 0
La Louviere
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Belgium
State/province [26] 0 0
Liege
Country [27] 0 0
Brazil
State/province [27] 0 0
Minas Gerais
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio Grande Do Sul
Country [29] 0 0
Brazil
State/province [29] 0 0
Sao Paulo
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio de Janeiro
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Plovdiv
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Varna
Country [34] 0 0
Canada
State/province [34] 0 0
Alberta
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Chile
State/province [36] 0 0
Santiago
Country [37] 0 0
China
State/province [37] 0 0
Guangdong
Country [38] 0 0
China
State/province [38] 0 0
Jiangsu
Country [39] 0 0
China
State/province [39] 0 0
Zhejiang
Country [40] 0 0
China
State/province [40] 0 0
Beijing
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Colombia
State/province [41] 0 0
Floridablanca
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Colombia
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Medellín
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France
State/province [43] 0 0
Bordeaux
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France
State/province [44] 0 0
Clichy
Country [45] 0 0
France
State/province [45] 0 0
Creteil
Country [46] 0 0
France
State/province [46] 0 0
La Roche Sur Yon
Country [47] 0 0
France
State/province [47] 0 0
Lille
Country [48] 0 0
France
State/province [48] 0 0
Lyon
Country [49] 0 0
France
State/province [49] 0 0
Marseille
Country [50] 0 0
France
State/province [50] 0 0
Paris
Country [51] 0 0
France
State/province [51] 0 0
Pessac
Country [52] 0 0
France
State/province [52] 0 0
Vandoeuvre-les-nancy
Country [53] 0 0
France
State/province [53] 0 0
Villejuif
Country [54] 0 0
Germany
State/province [54] 0 0
Baden-Württemberg
Country [55] 0 0
Germany
State/province [55] 0 0
Bayern
Country [56] 0 0
Germany
State/province [56] 0 0
Hessen
Country [57] 0 0
Germany
State/province [57] 0 0
Niedersachsen
Country [58] 0 0
Germany
State/province [58] 0 0
Nordrhein-Westfalen
Country [59] 0 0
Germany
State/province [59] 0 0
Rheinland-Pfalz
Country [60] 0 0
Germany
State/province [60] 0 0
Saarland
Country [61] 0 0
Germany
State/province [61] 0 0
Berlin
Country [62] 0 0
Greece
State/province [62] 0 0
Athens
Country [63] 0 0
Greece
State/province [63] 0 0
Larissa
Country [64] 0 0
Greece
State/province [64] 0 0
Thessaloniki
Country [65] 0 0
Hong Kong
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Hong Kong
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Hong Kong
State/province [66] 0 0
Shatin
Country [67] 0 0
Israel
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Beer Sheva
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Israel
State/province [68] 0 0
Haifa
Country [69] 0 0
Israel
State/province [69] 0 0
Petah Tikva
Country [70] 0 0
Israel
State/province [70] 0 0
Rehovot
Country [71] 0 0
Israel
State/province [71] 0 0
Zrifin
Country [72] 0 0
Italy
State/province [72] 0 0
Lombardia
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Gyeonggido
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Korea, Republic of
State/province [74] 0 0
Seoul
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Wellington South
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Peru
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Lima
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Gliwice
Country [82] 0 0
Poland
State/province [82] 0 0
Warszawa
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Barnaul
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Moscow
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Nizhny Novgorod
Country [86] 0 0
Singapore
State/province [86] 0 0
Singapore
Country [87] 0 0
South Africa
State/province [87] 0 0
Gauteng
Country [88] 0 0
South Africa
State/province [88] 0 0
Western Cape
Country [89] 0 0
Spain
State/province [89] 0 0
Barcelona
Country [90] 0 0
Spain
State/province [90] 0 0
Lugo
Country [91] 0 0
Spain
State/province [91] 0 0
Madrid
Country [92] 0 0
Spain
State/province [92] 0 0
Santander
Country [93] 0 0
Spain
State/province [93] 0 0
Valencia
Country [94] 0 0
Taiwan
State/province [94] 0 0
Tainan
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taipei
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taoyuan
Country [97] 0 0
United Kingdom
State/province [97] 0 0
South Yorkshire
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Glasgow
Country [99] 0 0
United Kingdom
State/province [99] 0 0
London
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Newcastle Upon Tyne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00901901