A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
Overview[ - collapse ][ - ]
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). |
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Condition | Carcinoma, Hepatocellular |
Intervention | Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin Drug: Doxorubicin/Placebo |
Phase | Phase 2 |
Sponsor | Bayer |
Responsible Party | Bayer |
ClinicalTrials.gov Identifier | NCT00108953 |
First Received | April 21, 2005 |
Last Updated | March 26, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | April 21, 2005 |
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Last Updated Date | March 26, 2014 |
Start Date | April 2005 |
Estimated Primary Completion Date | April 2008 |
Current Primary Outcome Measures | Time to Progression (TTP) [Time Frame: from date of randomization of the first patient until 3 years later] [Designated as safety issue: No]TTP was defined as the time from randomization to radiological disease progression by independent assessment. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma |
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Official Title | A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma. |
Brief Summary | 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). |
Detailed Description | 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., cardiotoxicity). |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Carcinoma, Hepatocellular |
Intervention | Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin Multi kinase inhibitor plus Chemotherapy Drug: Doxorubicin/Placebo Chemotherapy plus Placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 96 |
Estimated Completion Date | April 2008 |
Estimated Primary Completion Date | April 2008 |
Eligibility 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: - 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 scan - 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Argentina, Canada, Hong Kong, Russian Federation, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00108953 |
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Other Study ID Numbers | 11546 |
Has Data Monitoring Committee | No |
Information Provided By | Bayer |
Study Sponsor | Bayer |
Collaborators | Not Provided |
Investigators | Study Director: Bayer Study Director Bayer |
Verification Date | March 2014 |
Locations[ + expand ][ + ]
United States, Alabama | Birmingham, Alabama, United States, 35294 |
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United States, California | Beverly Hills, California, United States, 90211-1850 |
United States, California | Orange, California, United States, 92668-3298 |
United States, California | Palo Alto, California, United States, 94304-1207 |
United States, California | San Francisco, California, United States, 94115 |
United States, California | San Francisco, California, United States, 94121 |
United States, California | Sylmar, California, United States, 91342 |
United States, Florida | Miami, Florida, United States, 33136 |
United States, Louisiana | Lafayette, Louisiana, United States, 70506 |
United States, Minnesota | Minneapolis, Minnesota, United States, 55455 |
United States, New Jersey | Hackensack, New Jersey, United States, 07601 |
United States, New York | New York, New York, United States, 10065 |
United States, New York | Rochester, New York, United States, 14642 |
United States, Tennessee | Nashville, Tennessee, United States, 37203 |
United States, Washington | Seattle, Washington, United States, 98101 |
Argentina, Ciudad Auton. de Buenos Aires | Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1264AAA |
Argentina, Neuquén | Neuquen, Neuquén, Argentina, Q8300HDH |
Argentina | Buenos Aires, Argentina |
Canada, Ontario | Toronto, Ontario, Canada, M5G 2M9 |
Hong Kong | Hong Kong, Hong Kong |
Russian Federation | Kazan, Russian Federation, 420111 |
Russian Federation | Kirov, Russian Federation, 610002 |
Russian Federation | Krasnodar, Russian Federation, 350040 |
United Kingdom, Kent | Maidstone, Kent, United Kingdom, ME16 9QQ |
United Kingdom, Merseyside | Bebington, Merseyside, United Kingdom, CH63 4JY |
United Kingdom, West Midlands | Birmingham, West Midlands, United Kingdom, B15 2TT |
United Kingdom | London, United Kingdom, W12 0HS |
United Kingdom | Manchester, United Kingdom, M20 4BX |