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A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (SHARP)

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sorafenib (Nexavar, BAY43-9006)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Liver Cancer, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sorafenib (Nexavar, BAY43-9006)

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Time to Symptomatic Progression (TTSP)
TTSP was defined as the time from randomization to the first documented symptomatic progression.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 14, 2005
Last Updated
October 24, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00105443
Brief Title
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Acronym
SHARP
Official Title
A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The following abbreviations were used in the Adverse Event section: international normalized ratio (inr) Common Terminology Criteria for Adverse Events (ctcae) Not Otherwise Specified (nos) Gastrointestinal (gi) Central nervous system (cns) Absolute Neutrophil Count (anc) Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) Creatine phosphokinase (cpk) Gammaglutamyltransferase (ggt) Genitourinary (gu) Atrioventricular (av)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Liver Cancer, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
602 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sorafenib (Nexavar, BAY43-9006)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar, BAY43-9006)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sorafenib-matching placebo tablets were orally administered twice daily (bid).
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
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
Title
Time to Symptomatic Progression (TTSP)
Description
TTSP was defined as the time from randomization to the first documented symptomatic progression.
Time Frame
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 Measure Information:
Title
Time to Progression (TTP)
Description
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.
Time Frame
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
Title
Disease Control (DC)
Description
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.
Time Frame
time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
Title
Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
Description
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.
Time Frame
from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054-4502
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7077
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92668-3298
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-8019
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0362
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2000
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030-3876
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-1502
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6174
Country
United States
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629AHJ
Country
Argentina
City
Bueno Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1417DTB
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1120AAF
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1145ADP
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
City
San Miguel de Tucumán
State/Province
Tucuman
ZIP/Postal Code
T4000GTB
Country
Argentina
City
San Miguel de Tucumán
State/Province
Tucuman
ZIP/Postal Code
T4000HXU
Country
Argentina
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1090
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-003
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90619900
Country
Brazil
City
Belo Horizonte
ZIP/Postal Code
30180090
Country
Brazil
City
Belo Horizonte
ZIP/Postal Code
30380490
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01246-903
Country
Brazil
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H8
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Santiago de Chile
State/Province
Santiago
ZIP/Postal Code
833-0024
Country
Chile
City
Santiago de Chile
Country
Chile
City
Santiago Región Metropolitana
Country
Chile
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Bondy
ZIP/Postal Code
93143
Country
France
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Clichy
ZIP/Postal Code
92110
Country
France
City
Dijon
ZIP/Postal Code
21000
Country
France
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
City
Marseille
ZIP/Postal Code
13005
Country
France
City
Nantes
ZIP/Postal Code
44805
Country
France
City
Paris
ZIP/Postal Code
75020
Country
France
City
Rennes Cedex
ZIP/Postal Code
35062
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54500
Country
France
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93042
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Haidari
State/Province
Attica
ZIP/Postal Code
12462
Country
Greece
City
Athens
ZIP/Postal Code
115 27
Country
Greece
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
City
Thessaloniki
ZIP/Postal Code
540 07
Country
Greece
City
Thessaloniki
ZIP/Postal Code
54639
Country
Greece
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
City
Haifa
ZIP/Postal Code
84801
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Zrifin
ZIP/Postal Code
70300
Country
Israel
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
City
Avellino
ZIP/Postal Code
83100
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Forlì
ZIP/Postal Code
47100
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Milano
ZIP/Postal Code
20133
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Palermo
ZIP/Postal Code
90127
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Pisa
ZIP/Postal Code
56126
Country
Italy
City
Roma
ZIP/Postal Code
00144
Country
Italy
City
México
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
City
México, D.F.
ZIP/Postal Code
06720
Country
Mexico
City
México, D.F.
ZIP/Postal Code
14050
Country
Mexico
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
City
Wellington South
ZIP/Postal Code
6001
Country
New Zealand
City
Comas Lima
Country
Peru
City
Lima Cercado
ZIP/Postal Code
LIMA 1
Country
Peru
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Poznan
ZIP/Postal Code
61-878
Country
Poland
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300223
Country
Romania
City
Craiova Dolj
ZIP/Postal Code
200642
Country
Romania
City
Iasi
ZIP/Postal Code
700111
Country
Romania
City
Ekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
City
Kirov
ZIP/Postal Code
610002
Country
Russian Federation
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
City
Moscow
ZIP/Postal Code
105 203
Country
Russian Federation
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
City
Moscow
ZIP/Postal Code
111 020
Country
Russian Federation
City
Moscow
ZIP/Postal Code
113 811
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129 010
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
188663
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
195 067
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
City
Tolgliatti
Country
Russian Federation
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Cruces/Barakaldo
State/Province
Bilbao
ZIP/Postal Code
48903
Country
Spain
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Valencia
ZIP/Postal Code
46014
Country
Spain
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX1 2JD
Country
United Kingdom
City
Glasgow
State/Province
Stratchclyde
ZIP/Postal Code
G11 6NT
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE2 4HH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18650514
Citation
Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
Results Reference
result
PubMed Identifier
28687477
Citation
Bruix J, Cheng AL, Meinhardt G, Nakajima K, De Sanctis Y, Llovet J. Prognostic factors and predictors of sorafenib benefit in patients with hepatocellular carcinoma: Analysis of two phase III studies. J Hepatol. 2017 Nov;67(5):999-1008. doi: 10.1016/j.jhep.2017.06.026. Epub 2017 Jul 4. Erratum In: J Hepatol. 2018 Oct;69(4):990-991.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

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