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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00105443




Registration number
NCT00105443
Ethics application status
Date submitted
14/03/2005
Date registered
15/03/2005
Date last updated
31/10/2014

Titles & IDs
Public title
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Scientific title
A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Secondary ID [1] 0 0
2004-001773-26
Secondary ID [2] 0 0
100554
Universal Trial Number (UTN)
Trial acronym
SHARP
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 - Placebo

Experimental: Sorafenib (Nexavar, BAY43-9006) - Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.

Placebo Comparator: Placebo - Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.


Treatment: Drugs: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.

Treatment: Drugs: Placebo
Sorafenib-matching placebo tablets were orally administered twice daily (bid).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Timepoint [1] 0 0
from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment
Primary outcome [2] 0 0
Time to Symptomatic Progression (TTSP) - TTSP was defined as the time from randomization to the first documented symptomatic progression.
Timepoint [2] 0 0
from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment
Secondary outcome [1] 0 0
Time to Progression (TTP) - TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.
Timepoint [1] 0 0
from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment
Secondary outcome [2] 0 0
Disease Control (DC) - The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.
Timepoint [2] 0 0
time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
Secondary outcome [3] 0 0
Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire - PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.
Timepoint [3] 0 0
from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment

Eligibility
Key inclusion criteria
- Ages eligible for study: 18 years and above, Genders eligible for study: both

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

- Patients with histologically or cytologically documented Hepatocellular Carcinoma
(HCC)

- Patients must have at least one tumor lesion that meets both of the following
criteria: (1) Accurately measured in at least one dimension according to RECIST
(Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local
therapy

- Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status)
of 0, 1, or 2
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous or concurrent cancer that is distinct in primary site or histology from HCC,
EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder
tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] &
T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3
years prior to entry is permitted

- Renal failure requiring hemo- or peritoneal dialysis

- History of cardiac disease

- Active clinically serious infections

- Known history of human immunodeficiency virus (HIV) infection

- Known central nervous system tumors including metastatic brain disease

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

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
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,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Randwick
Recruitment hospital [3] 0 0
- Westmead
Recruitment hospital [4] 0 0
- East Bentleigh
Recruitment hospital [5] 0 0
- Heidelberg
Recruitment hospital [6] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3052 - Melbourne
Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Georgia
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Illinois
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Kentucky
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Michigan
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Missouri
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Nebraska
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New York
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Ohio
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Oregon
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Pennsylvania
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Texas
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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Auton. de Buenos Aires
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Argentina
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Tucuman
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Belgium
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Brugge
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Belgium
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Bruxelles - Brussel
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Belgium
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Gent
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Belgium
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Leuven
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Brazil
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Rio Grande do Sul
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Brazil
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Belo Horizonte
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Brazil
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Sao Paulo
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Bulgaria
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Varna
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Canada
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Alberta
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British Columbia
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Chile
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Santiago Región Metropolitana
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Croatia
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Zagreb
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Bondy
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Bordeaux
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France
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Clichy
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France
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Dijon
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France
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Lille Cedex
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France
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Marseille
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France
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Nantes
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France
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Paris
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France
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Rennes Cedex
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Vandoeuvre-les-nancy
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Germany
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Bayern
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Hessen
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Niedersachsen
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Saarland
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Sachsen-Anhalt
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Berlin
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Hamburg
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Greece
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Attica
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Athens
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Ioannina
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Thessaloniki
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Haifa
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Petach Tikva
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Tel Aviv
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Israel
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Zrifin
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Milano
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Avellino
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Padova
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Pavia
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Comas Lima
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Lima
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Gdansk
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Poland
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Warszawa
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Romania
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Timis
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Romania
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Craiova Dolj
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Iasi
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Russian Federation
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Ekaterinburg
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Kirov
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Tolgliatti
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Spain
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Barcelona
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Bilbao
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Alicante
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Córdoba
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Madrid
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Pamplona
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Spain
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Valencia
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Switzerland
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Sankt Gallen
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Switzerland
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Bern
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Switzerland
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Genève
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Switzerland
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Zürich
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United Kingdom
State/province [109] 0 0
Avon
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United Kingdom
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Oxfordshire
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United Kingdom
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Stratchclyde
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United Kingdom
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London
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United Kingdom
State/province [113] 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
The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find
out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents
the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics
(PK) in patients with liver cancer.
Trial website
https://clinicaltrials.gov/show/NCT00105443
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
Other publications