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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00699374




Registration number
NCT00699374
Ethics application status
Date submitted
16/06/2008
Date registered
18/06/2008
Date last updated
14/01/2013

Titles & IDs
Public title
Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
Scientific title
A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma
Secondary ID [1] 0 0
A6181170
Universal Trial Number (UTN)
Trial acronym
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 - sunitinib malate
Treatment: Drugs - sorafenib

Experimental: Arm A - sunitinib arm

Active comparator: Arm B - sorafenib arm


Treatment: Drugs: sunitinib malate
sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.

Treatment: Drugs: sorafenib
sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Secondary outcome [2] 0 0
Time to Tumor Progression (TTP)
Timepoint [2] 0 0
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Secondary outcome [3] 0 0
European Quality of Life (EQ-5D)- Health State Profile Utility Score
Timepoint [3] 0 0
Day 1 of each cycle

Eligibility
Key inclusion criteria
* Histologically-confirmed diagnosis of hepatocellular carcinoma
* presence of measurable disease by radiographic imaging
* Child-Pugh class A
* ECOG PS 0 or 1
* adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with any systemic treatment for hepatocellular carcinoma
* prior local treatment within 4 weeks from entry
* presence of clinically relevant ascites
* severe hemorrhage <4 weeks of starting study treatment
* known HIV or serious acute or chronic illness
* current treatment on another clinical trial
* pregnancy or breastfeeding

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
1075
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Concord
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Elizabeth Vale
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Woodville South
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Melbourne
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Iowa
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United States of America
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Kentucky
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Tennessee
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United States of America
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Virginia
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United States of America
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Washington
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Belgium
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Bruxelles
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Belgium
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Gent
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Anhui
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China
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Fujian
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China
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Guangdong
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China
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Guangxi
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China
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Hubei
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China
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Jiangsu
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China
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Sichuan
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China
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Zhejiang
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China
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Beijing
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China
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Bejing
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Chong qing
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Guangzhou
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China
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Nanjing
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China
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Shanghai
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France
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Amiens Cedex 1
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France
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Bordeaux Cedex
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Clichy Cedex
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Creteil Cedex
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Lille Cedex
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France
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Nice Cedex 2
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France
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Paris Cedex 13
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France
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Paris
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France
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St Herblain Cedex
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France
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France
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Toulouse
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France
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Vandoeuvre Les Nancy Cedex
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France
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Villejuif Cedex
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Mainz
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Germany
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Muenchen
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Hong Kong
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Hong Hong
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Hong Kong
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Kowloon
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Hong Kong
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Shatin, New Territories
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Hong Kong
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Tuen Mun, New Territories
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Italy
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FC
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Bari
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Bologna
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Pavia
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Ravenna
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Okayama
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Korea, Republic of
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Chonbuk
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Gyeonggi-do
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Busan
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Daegu
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Incheon
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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Poland
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Warszawa
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Russian Federation
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Chelyabinsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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St.Petersburg
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Singapore
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Singapore
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South Africa
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Parktown
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Barcelona
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Cantabria
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Illes Balears
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Murcia
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Spain
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Sevilla
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Sweden
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Taichung
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Tainan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Turkey
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Ankara
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Turkey
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Istanbul
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Cambridgeshire
Country [113] 0 0
United Kingdom
State/province [113] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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/NCT00699374