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A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
This study has been completed.
First Received: June 26, 2007   Last Updated: August 20, 2009   History of Changes
Sponsor: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00492752
  Purpose

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

Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Nexavar (Sorafenib, BAY43-9006)
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-blinded, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: longterm follow up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to symptomatic progression [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
  • Overall disease control rate [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
  • Patient report outcomes [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
  • Overall response rate (proportion of patients with confirmed partial and complete responses) [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
  • Overall response duration duration and time to objective response [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
  • Time to response, Pharmacokinetic profile, Safety, [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
  • Evaluate possible and potentially predictive assays of clinical benefit through an exploratory assessment of the correlation between the defined baseline characteristics and key clinical endpoints. [ Time Frame: screening, C3D1, EOT ] [ Designated as safety issue: Yes ]
  • Correlation between the following baseline characteristics and key clinical endpoints (i.e., response, TTP, TTSP, and OS): tumor pERK, phospho VEGF-R2 concentration, plasma proteomics, and gene expression profiling of blood cells and tumor biopsies [ Time Frame: follow up visit ] [ Designated as safety issue: No ]

Enrollment: 226
Study Start Date: October 2005
Study Completion Date: June 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental Drug: Nexavar (Sorafenib, BAY43-9006)
multikinase inhibitor; sorafenib 400 mg (orally) twice daily
Arm 2: Placebo Comparator Drug: Placebo
Matching placebo (orally) twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 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 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, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
  • History of cardiac disease
  • Active clinically serious infections
  • Known history of HIV infection
  • Known CNS tumors including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492752

Locations
China
Beijing, China, 100021
Beijing, China, 100039
Tianjin, China
Chongqing, China, 400038
Shanghai, China, 200003
Shanghai, China, 200032
China, Anhuii
Hefei, Anhuii, China, 230022
China, Guangdong
Guangzhou, Guangdong, China, 510060
Guangzhou, Guangdong, China, 510515
China, Hubei
Wuhan, Hubei, China, 430030
China, Jiangsu
Nanjing, Jiangsu, China, 210002
Nanjing, Jiangsu, China, 210009
China, Liaoning
Dalian, Liaoning, China, 116011
Dalian, Liaoning, China, 116027
China, Zhejiang
Hangzhou, Zhejiang, China, 310016
Korea, Republic of
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 152-703
Daegu, Korea, Republic of, 702-701
Taiwan
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
Taipei, Taiwan, 112
Changhua, Taiwan, 500
Tainan, Taiwan, 736
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers: 11849
Study First Received: June 26, 2007
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00492752     History of Changes
Health Authority: Taiwan: National Bureau of Controlled Drugs;   China: State Food and Drug Administration;   South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Hepatocellular
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 05, 2009