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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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Arizona
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California
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Connecticut
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Florida
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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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Oregon
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Pennsylvania
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Texas
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Virginia
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Washington
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Argentina
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Buenos Aires
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Ciudad Auton. de Buenos Aires
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Tucuman
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Brugge
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Bruxelles - Brussel
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Gent
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Leuven
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Rio Grande do Sul
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Sofia
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Varna
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Zrifin
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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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Kazan
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Kirov
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Tolgliatti
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Spain
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Barcelona
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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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Genève
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Zürich
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Avon
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Oxfordshire
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Stratchclyde
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United Kingdom
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London
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United Kingdom
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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

TypeCitations or Other Details
Journal Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane ... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00105443