Trial Condition(s):
Carcinoma, Hepatocellular
A Research Study to Treat Patients with Advanced Hepatocellular Carcinoma
Bayer Identifier:
11546
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial 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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Clatterbridge Centre for Oncology Bebington, United Kingdom, CH63 4JY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christie Hospital Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kent Oncology Centre Maidstone, United Kingdom, ME16 9QQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations VA Palo Alto Health Care System Palo Alto, United States, 94304-1207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations California Pacific Medical Center San Francisco, United States, 94115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hackensack University Medical Center Hackensack, United States, 07601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Rochester Medical Center Rochester, United States, 14642 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Veterans Affairs Medical Center-San Francisco San Francisco, United States, 94121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Margaret Hospital-University Health Network Toronto, Canada, M5G 2M9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Unidad Oncológica de Neuquén Neuquen, Argentina, Q8300HDH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hosp. Mun. de Gastroenterología Dr. Carlos Bonorino Udaondo Buenos Aires, Argentina, C1264AAA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncology Centre of Kazan State Medical University Kazan, Russia, 420111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krasnodar City Oncology Center Krasnodar, Russia, 350040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kirov State Medical Academy Kirov, Russia, 610002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Birmingham Birmingham, United Kingdom, B15 2TT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hammersmith Hospital London, United Kingdom, W12 0HS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Memorial Sloan-Kettering Cancer Center New York, United States, 10065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Miami School of Medicine Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Minnesota Minneapolis, United States, 55455 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sarah Cannon Cancer Center Nashville, United States, 37203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tower Hematology/Oncology Medical Group Beverly Hills, United States, 90211-1850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Virginia Mason Medical Center Seattle, United States, 98101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UCLA Medical Center-Olive View Sylmar, United States, 91342 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UC Irvine Medical Center Orange, United States, 92668-3298 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Louisiana Oncology Associates, PMC Lafayette, United States, 70506 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alabama at Birmingham Birmingham, United States, 35294 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Británico Buenos Aires, Argentina | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized controlled study of BAY43-9006 in combination with doxorubicin versus doxorubicin in patients with advanced hepatocellular carcinoma.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Time to Progression (TTP)Timeframe: from date of randomization of the first patient until 3 years later
Secondary Outcome
- Overall SurvivalTimeframe: from date of randomization of the first patient until 3 years later
- Progression Free Survival (PFS)Timeframe: from date of randomization of the first patient until 3 years later
- Percentage of Participants in Each Category of Best Tumor ResponseTimeframe: achieved during treatment or within 30 days after termination of active therapy
- Time to Symptomatic Progression (TTSP)Timeframe: from date of randomization of the first patient until 3 years later
- Duration of ResponseTimeframe: from date of randomization of the first patient until 3 years later
- Time to Response (TTR)Timeframe: from date of randomization until 3 years later at end of study
- Percentage of Participants for Whom Disease Control Was AchievedTimeframe: from date of randomization to end of treatment plus 30 days
Additional Information
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