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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
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) - The period from randomization until disease progression or death.
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) - Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])
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 - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula assigns a utility value for each domain in the profile. Score is transformed and results in a score range -0.594 to 1.000; higher score indicates better health state.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
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California
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Florida
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Kentucky
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Ohio
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Tennessee
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Virginia
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Washington
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Bruxelles
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Ontario
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Anhui
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Shanghai
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Amiens Cedex 1
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Toulouse
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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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Mainz
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Germany
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Muenchen
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Hong Hong
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Kowloon
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Shatin, New Territories
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Tuen Mun, New Territories
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Pyatigorsk
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Russian Federation
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Barcelona
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Murcia
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Sevilla
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Sweden
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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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Istanbul
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United Kingdom
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Cambridgeshire
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United Kingdom
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London

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

Ethics approval
Ethics application status

Summary
Brief summary
The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally
once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients
with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A
and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be
given until disease progression, occurrence of unacceptable toxicity, or other withdrawal
criteria are met. After discontinuation of study treatment, patients will be followed up in
order to collect information on further antineoplastic therapy and survival.
Trial website
https://clinicaltrials.gov/show/NCT00699374
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00699374