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A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma

This study is ongoing, but not recruiting participants.

Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00108953
  Purpose

The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).


Condition Intervention Phase
Cancer
Liver Cancer
Hepatocellular Carcinoma (HCC)
Drug: Nexavar (Sorafenib, BAY43-9006) plus doxorubicin
Drug: doxorubicin
Phase II

MedlinePlus related topics:   Cancer    Liver Cancer   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Sorafenib    Sorafenib tosylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Randomized Controlled Study of BAY 43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.

Further study details as provided by Bayer:

Primary Outcome Measures:
  • to evaluate the effect of doxorubicin plus sorafenib or doxorubicin plus placebo on TTP [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
  • The overall response rate [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
  • Time to symptomatic progression (TTSP) [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
  • In an exploratory manner the relative TTP, TTSP, RR and overall survival between the 2 study populations [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
  • Overall response duration and time to objective response [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
  • Overall disease control rate [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
  • The safety, tolerability, and adverse event profiles of the two treatment regimens used in this trial [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
  • To 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: 31 March 2008 ] [ Designated as safety issue: No ]
  • To compare doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo, and to correlate the PK data with doxorubicin-related adverse events (i.e., cardiotoxicity). [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]

Enrollment:   96
Study Start Date:   April 2005
Estimated Study Completion Date:   March 2008

Arms Assigned Interventions
Arm 1: Experimental Drug: Nexavar (Sorafenib, BAY43-9006) plus doxorubicin
multi kinase inhibitor plus chemotherapy
Arm 2: Active Comparator Drug: doxorubicin
chemotherapy plus placebo

Detailed Description:

Number of arms: 2

(Doxorubicin + BAY 43-9006 versus Doxorubicin + Placebo)

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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 criteria: 1) can be accurately measured in at least one dimension according to RECIST; 2) 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 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, 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 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: NCT00108953

Locations
United States, California
      Palo Alto, California, United States, 94304-1207
      San Francisco, California, United States, 94115
      Beverly Hills, California, United States, 90211-1850
      Sylmar, California, United States, 91342
      San Francisco, California, United States, 94121
United States, Florida
      Miami, Florida, United States, 33136
United States, Minnesota
      Minneapolis, Minnesota, United States, 55455
United States, New Jersey
      Hackensack, New Jersey, United States, 07601-1991
United States, New York
      New York, New York, United States, 10021-6007
      Rochester, New York, United States, 14642
United States, Tennessee
      Nashville, Tennessee, United States, 37203
United States, Washington
      Seattle, Washington, United States, 98101
Argentina
Bayer Clinical Research Center    
      ask Contact, Argentina
Canada
Bayer Clinical Research Center    
      ask Contact, Canada
Hong Kong
Bayer Clinical Research Center    
      ask Contact, Hong Kong
Russian Federation
Bayer Clinical Research Center    
      ask Contact, Russian Federation
United Kingdom
Bayer Clinical Research Center    
      ask Contact, United Kingdom

Sponsors and Collaborators
Bayer

Investigators
Study Director:     Bayer Study Director     Bayer    
  More Information

Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
 
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site
 

Responsible Party:   ( Bayer HealthCare AG, Therapeutic Area Head )
Study ID Numbers:   11546, EudraCT 2004-001770-40
First Received:   April 21, 2005
Last Updated:   December 31, 2007
ClinicalTrials.gov Identifier:   NCT00108953
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Doxorubicin
Carcinoma
Liver Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antibiotics, Antineoplastic
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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