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

Bayer

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00494299

11721

Details and patient eligibility

About

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

Enrollment: 458 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Aged of 18 and over
• Advanced hepatocellular carcinoma

Exclusion criteria

• History of prior systemic chemotherapy
• Failure in vital organ

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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458 participants in 2 patient groups, including a placebo group

Sorafenib (Nexavar, BAY43-9006)

Experimental group

Description:

Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)

Placebo

Placebo Comparator group

Description:

Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).

Treatment:

Drug: Placebo