Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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)
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)
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)
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)
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
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
Sex
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
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
602
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Ciudad Auton. de Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Tucuman
Country [21] 0 0
Belgium
State/province [21] 0 0
Brugge
Country [22] 0 0
Belgium
State/province [22] 0 0
Bruxelles - Brussel
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Belgium
State/province [24] 0 0
Leuven
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio Grande do Sul
Country [26] 0 0
Brazil
State/province [26] 0 0
Belo Horizonte
Country [27] 0 0
Brazil
State/province [27] 0 0
Sao Paulo
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Stara Zagora
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Varna
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
Manitoba
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
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
Chile
State/province [37] 0 0
Santiago de Chile
Country [38] 0 0
Chile
State/province [38] 0 0
Santiago Región Metropolitana
Country [39] 0 0
Croatia
State/province [39] 0 0
Zagreb
Country [40] 0 0
France
State/province [40] 0 0
Bondy
Country [41] 0 0
France
State/province [41] 0 0
Bordeaux
Country [42] 0 0
France
State/province [42] 0 0
Clichy
Country [43] 0 0
France
State/province [43] 0 0
Dijon
Country [44] 0 0
France
State/province [44] 0 0
Lille Cedex
Country [45] 0 0
France
State/province [45] 0 0
Marseille
Country [46] 0 0
France
State/province [46] 0 0
Nantes
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
France
State/province [48] 0 0
Rennes Cedex
Country [49] 0 0
France
State/province [49] 0 0
Vandoeuvre-les-nancy
Country [50] 0 0
Germany
State/province [50] 0 0
Baden-Württemberg
Country [51] 0 0
Germany
State/province [51] 0 0
Bayern
Country [52] 0 0
Germany
State/province [52] 0 0
Hessen
Country [53] 0 0
Germany
State/province [53] 0 0
Niedersachsen
Country [54] 0 0
Germany
State/province [54] 0 0
Nordrhein-Westfalen
Country [55] 0 0
Germany
State/province [55] 0 0
Rheinland-Pfalz
Country [56] 0 0
Germany
State/province [56] 0 0
Saarland
Country [57] 0 0
Germany
State/province [57] 0 0
Sachsen-Anhalt
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin
Country [59] 0 0
Germany
State/province [59] 0 0
Hamburg
Country [60] 0 0
Greece
State/province [60] 0 0
Attica
Country [61] 0 0
Greece
State/province [61] 0 0
Athens
Country [62] 0 0
Greece
State/province [62] 0 0
Ioannina
Country [63] 0 0
Greece
State/province [63] 0 0
Thessaloniki
Country [64] 0 0
Israel
State/province [64] 0 0
Haifa
Country [65] 0 0
Israel
State/province [65] 0 0
Petach Tikva
Country [66] 0 0
Israel
State/province [66] 0 0
Tel Aviv
Country [67] 0 0
Israel
State/province [67] 0 0
Zrifin
Country [68] 0 0
Italy
State/province [68] 0 0
Milano
Country [69] 0 0
Italy
State/province [69] 0 0
Avellino
Country [70] 0 0
Italy
State/province [70] 0 0
Bologna
Country [71] 0 0
Italy
State/province [71] 0 0
Forlì
Country [72] 0 0
Italy
State/province [72] 0 0
Padova
Country [73] 0 0
Italy
State/province [73] 0 0
Palermo
Country [74] 0 0
Italy
State/province [74] 0 0
Pavia
Country [75] 0 0
Italy
State/province [75] 0 0
Pisa
Country [76] 0 0
Italy
State/province [76] 0 0
Roma
Country [77] 0 0
Mexico
State/province [77] 0 0
Distrito Federal
Country [78] 0 0
Mexico
State/province [78] 0 0
Monterrey
Country [79] 0 0
Mexico
State/province [79] 0 0
México, D.F.
Country [80] 0 0
New Zealand
State/province [80] 0 0
Auckland
Country [81] 0 0
New Zealand
State/province [81] 0 0
Wellington South
Country [82] 0 0
Peru
State/province [82] 0 0
Comas Lima
Country [83] 0 0
Peru
State/province [83] 0 0
Lima Cercado
Country [84] 0 0
Peru
State/province [84] 0 0
Lima
Country [85] 0 0
Poland
State/province [85] 0 0
Gdansk
Country [86] 0 0
Poland
State/province [86] 0 0
Poznan
Country [87] 0 0
Poland
State/province [87] 0 0
Warszawa
Country [88] 0 0
Romania
State/province [88] 0 0
Timis
Country [89] 0 0
Romania
State/province [89] 0 0
Craiova Dolj
Country [90] 0 0
Romania
State/province [90] 0 0
Iasi
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Ekaterinburg
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Kazan
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Kirov
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Krasnodar
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Moscow
Country [96] 0 0
Russian Federation
State/province [96] 0 0
St. Petersburg
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Tolgliatti
Country [98] 0 0
Spain
State/province [98] 0 0
Barcelona
Country [99] 0 0
Spain
State/province [99] 0 0
Bilbao
Country [100] 0 0
Spain
State/province [100] 0 0
Alicante
Country [101] 0 0
Spain
State/province [101] 0 0
Córdoba
Country [102] 0 0
Spain
State/province [102] 0 0
Madrid
Country [103] 0 0
Spain
State/province [103] 0 0
Pamplona
Country [104] 0 0
Spain
State/province [104] 0 0
Valencia
Country [105] 0 0
Switzerland
State/province [105] 0 0
Sankt Gallen
Country [106] 0 0
Switzerland
State/province [106] 0 0
Bern
Country [107] 0 0
Switzerland
State/province [107] 0 0
Genève
Country [108] 0 0
Switzerland
State/province [108] 0 0
Zürich
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Avon
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Oxfordshire
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Stratchclyde
Country [112] 0 0
United Kingdom
State/province [112] 0 0
London
Country [113] 0 0
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00105443