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A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.

Phase 2
18 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.

In addition to the key secondary outcome parameters the following parameters will be
assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic
progression (TTSP), response rate (RR) and overall survival between the 2 study populations.

The possible and potential predictive assays of clinical benefit through an assessment of
the correlation between the defined baseline characteristics and key clinical endpoints.

The safety and tolerability will be assessed in the adverse event section. Doxorubicin
pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and
the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e.,

Inclusion Criteria:

- 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

- can be accurately measured in at least one dimension according to Response
Evaluation Criteria in Solid Tumors (RECIST)

- has not been previously treated with local therapy

- Patients who have received local therapy except chemoembolization, such as surgery,
radiation therapy, hepatic arterial embolization, radiofrequency ablation,
percutaneous ethanol injection or cryoablation are eligible, provided that they
either have a target lesion which has not been subjected to local therapy and/or the
target lesion(s) within the field of the local therapy has shown an increase of 25%
in the size. Local therapy must be completed at least 4 weeks prior to the baseline

- Patients who have an Eastern Cooperative 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, and superficial
bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to
entry is permitted

- History of cardiac disease

- Serious myocardial dysfunction

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Time to Progression (TTP)

Outcome Description:

TTP was defined as the time from randomization to radiological disease progression by independent assessment.

Outcome Time Frame:

from date of randomization of the first patient until 3 years later

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

April 2008

Related Keywords:

  • Carcinoma, Hepatocellular
  • Cancer
  • Liver Cancer
  • Hepatocellular carcinoma
  • HCC
  • Carcinoma
  • Carcinoma, Hepatocellular



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