A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

NCT ID: NCT00492752

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2009-07-31

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

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sorafenib (Nexavar, BAY43-9006)

Sorafenib 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.

Group Type: EXPERIMENTAL

Sorafenib (Nexavar, BAY43-9006)

Intervention Type: DRUG

multikinase inhibitor; Sorafenib 400 mg (orally) twice daily

Placebo

Placebo tablets matching in appearance were orally administered bid (twice daily).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo (orally) twice daily

Interventions

Sorafenib (Nexavar, BAY43-9006)

multikinase inhibitor; Sorafenib 400 mg (orally) twice daily

Intervention Type: DRUG

Placebo

Matching placebo (orally) twice daily

Intervention Type: DRUG

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 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

1. Accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)

2. 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

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Hefei, Anhui, China

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Wuhan, Hubei, China

Nanjing, Jiangsu, China

Nanjing, Jiangsu, China

Dalian, Liaoning, China

Dalian, Liaoning, China

Hangzhou, Zhejiang, China

Beijing, , China

Beijing, , China

Chongqing, , China

Shanghai, , China

Shanghai, , China

Tianjin, , China

Seoul, Seoul Teugbyeolsi, South Korea

Daegu, , South Korea

Seoul, , South Korea

Changhua, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Countries

China; South Korea; Taiwan

References

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.

Reference Type: RESULT

PMID: 19095497 (View on PubMed)

Cheng 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.

Reference Type: RESULT

PMID: 22240282 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28687477 (View on PubMed)

Other Identifiers

11849

Identifier Type: -

Identifier Source: org_study_id