Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Carcinoma, Hepatocellular Clinical Trial

Official title:

Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494299
• Other study ID #: 11721
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2007
• Last updated: November 26, 2013
• Start date: April 2006
• Est. completion date: November 2010

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: November 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female

• Aged of 18 and over

• Advanced hepatocellular carcinoma

Exclusion Criteria:

• History of prior systemic chemotherapy

• Failure in vital organ

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
• Placebo
Placebo: matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

References & Publications (1)

Kudo M, Imanaka K, Chida N, Nakachi K, Tak WY, Takayama T, Yoon JH, Hori T, Kumada H, Hayashi N, Kaneko S, Tsubouchi H, Suh DJ, Furuse J, Okusaka T, Tanaka K, Matsui O, Wada M, Yamaguchi I, Ohya T, Meinhardt G, Okita K. Phase III study of sorafenib after — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression (TTP)	Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.	From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.	No
Secondary	Overall Survival (OS)	Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.	From randomization of the first subject until 39 months later.	No

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