A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
A Randomized, Double-blinded, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
1 other identifier
interventional
226
3 countries
23
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 or shrinks liver tumors and / or their metastases
- Determine the pharmacokinetics (PK) in patients with liver cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2005
Typical duration for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
January 13, 2011
CompletedApril 16, 2014
March 1, 2014
1.4 years
June 26, 2007
December 8, 2010
March 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
Secondary Outcomes (13)
Time to Symptomatic Progression (TTSP)
From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
Time to Progression (TTP)
From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
Disease Control
From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
Change in Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) Score From Baseline to Cycle 1 and Cycle 3
Baseline up to Cycle 1 and Cycle 3. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Score From Baseline to Cycle 3 and End of Treatment
Baseline up to Cycle 3 and end of treatment. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
- +8 more secondary outcomes
Study Arms (2)
Sorafenib (Nexavar, BAY43-9006)
EXPERIMENTALSorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
Placebo
PLACEBO COMPARATORPlacebo tablets matching in appearance were orally administered bid (twice daily).
Interventions
multikinase inhibitor; Sorafenib 400 mg (orally) twice daily
Eligibility Criteria
You may qualify if:
- 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 advanced Hepatocellular carcinoma (HCC) (unresectable, and/or metastatic) which has been histologically or cytologically documented
- Patients must have at least one tumor lesion that meets both of the following criteria
- Accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Not been previously treated with local therapy
- Patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible. Previously treated lesions will not be selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan
- Patients who have an Eastern Co-operative Oncology Group (ECOG) Performance Status of 0, 1, or 2
You may not qualify if:
- 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
- History of cardiac disease
- Active clinically serious infections
- Known history of human immunodeficiency virus (HIV) infection
- Known central nervous system (CNS) tumors including metastatic brain disease
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (23)
Unknown Facility
Hefei, Anhui, 230022, China
Unknown Facility
Guangzhou, Guangdong, 510060, China
Unknown Facility
Guangzhou, Guangdong, 510515, China
Unknown Facility
Wuhan, Hubei, 430030, China
Unknown Facility
Nanjing, Jiangsu, 210003, China
Unknown Facility
Nanjing, Jiangsu, 210009, China
Unknown Facility
Dalian, Liaoning, 116011, China
Unknown Facility
Dalian, Liaoning, 116027, China
Unknown Facility
Hangzhou, Zhejiang, 310016, China
Unknown Facility
Beijing, 100021, China
Unknown Facility
Beijing, 100039, China
Unknown Facility
Chongqing, 400038, China
Unknown Facility
Shanghai, 200003, China
Unknown Facility
Shanghai, 200032, China
Unknown Facility
Tianjin, China
Unknown Facility
Seoul, Seoul Teugbyeolsi, 152-703, South Korea
Unknown Facility
Daegu, 702-701, South Korea
Unknown Facility
Seoul, 138-736, South Korea
Unknown Facility
Changhua, 500, Taiwan
Unknown Facility
Tainan, 736, Taiwan
Unknown Facility
Taipei, 10016, Taiwan
Unknown Facility
Taipei, 251, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
Related Publications (3)
Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.
PMID: 19095497RESULTCheng AL, Guan Z, Chen Z, Tsao CJ, Qin S, Kim JS, Yang TS, Tak WY, Pan H, Yu S, Xu J, Fang F, Zou J, Lentini G, Voliotis D, Kang YK. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: subset analyses of the phase III Sorafenib Asia-Pacific trial. Eur J Cancer. 2012 Jul;48(10):1452-65. doi: 10.1016/j.ejca.2011.12.006. Epub 2012 Jan 10.
PMID: 22240282RESULTBruix 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.
PMID: 28687477DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
On review of unblinded data, up to 19 Mar. 2007, the independent Data Monitoring Committee concluded the efficacy results can be considered positive, recommended subjects under placebo to cross over to Sorafenib; study continued to extension phase.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 27, 2007
Study Start
October 1, 2005
Primary Completion
March 1, 2007
Study Completion
July 1, 2009
Last Updated
April 16, 2014
Results First Posted
January 13, 2011
Record last verified: 2014-03