check_circleStudy Completed
Carcinoma, Hepatocellular
Bayer Identifier:
11546
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A Research Study to Treat Patients with Advanced Hepatocellular Carcinoma
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).
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
96Trial Dates
April 2005 - April 2008Phase
Phase 2Could I Receive a placebo
YesProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Clatterbridge Centre for Oncology | Bebington, CH63 4JY, United Kingdom |
Completed | Christie Hospital | Manchester, M20 4BX, United Kingdom |
Completed | Kent Oncology Centre | Maidstone, ME16 9QQ, United Kingdom |
Completed | VA Palo Alto Health Care System | Palo Alto, 94304-1207, United States |
Completed | California Pacific Medical Center | San Francisco, 94115, United States |
Completed | Hackensack University Medical Center | Hackensack, 07601, United States |
Completed | University of Rochester Medical Center | Rochester, 14642, United States |
Completed | Veterans Affairs Medical Center-San Francisco | San Francisco, 94121, United States |
Completed | Princess Margaret Hospital-University Health Network | Toronto, M5G 2M9, Canada |
Completed | Unidad Oncológica de Neuquén | Neuquen, Q8300HDH, Argentina |
Completed | Hosp. Mun. de Gastroenterología Dr. Carlos Bonorino Udaondo | Buenos Aires, C1264AAA, Argentina |
Completed | Oncology Centre of Kazan State Medical University | Kazan, 420111, Russia |
Completed | Krasnodar City Oncology Center | Krasnodar, 350040, Russia |
Completed | Kirov State Medical Academy | Kirov, 610002, Russia |
Completed | University of Birmingham | Birmingham, B15 2TT, United Kingdom |
Completed | Hammersmith Hospital | London, W12 0HS, United Kingdom |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10065, United States |
Completed | University of Miami School of Medicine | Miami, 33136, United States |
Completed | University of Minnesota | Minneapolis, 55455, United States |
Completed | Sarah Cannon Cancer Center | Nashville, 37203, United States |
Completed | Tower Hematology/Oncology Medical Group | Beverly Hills, 90211-1850, United States |
Completed | Virginia Mason Medical Center | Seattle, 98101, United States |
Completed | UCLA Medical Center-Olive View | Sylmar, 91342, United States |
Completed | UC Irvine Medical Center | Orange, 92668-3298, United States |
Completed | Louisiana Oncology Associates, PMC | Lafayette, 70506, United States |
Completed | University of Alabama at Birmingham | Birmingham, 35294, United States |
Completed | Hospital Británico | Buenos Aires, Argentina |
Completed | Hong Kong, Hong Kong |
Primary Outcome
- Time to Progression (TTP)date_rangeTime Frame:from date of randomization of the first patient until 3 years laterenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Overall Survivaldate_rangeTime Frame:from date of randomization of the first patient until 3 years laterenhanced_encryptionNoSafety Issue:
- Progression Free Survival (PFS)date_rangeTime Frame:from date of randomization of the first patient until 3 years laterenhanced_encryptionNoSafety Issue:
- Percentage of Participants in Each Category of Best Tumor Responsedate_rangeTime Frame:achieved during treatment or within 30 days after termination of active therapyenhanced_encryptionNoSafety Issue:
- Time to Symptomatic Progression (TTSP)date_rangeTime Frame:from date of randomization of the first patient until 3 years laterenhanced_encryptionNoSafety Issue:
- Duration of Responsedate_rangeTime Frame:from date of randomization of the first patient until 3 years laterenhanced_encryptionNoSafety Issue:
- Time to Response (TTR)date_rangeTime Frame:from date of randomization until 3 years later at end of studyenhanced_encryptionNoSafety Issue:
- Percentage of Participants for Whom Disease Control Was Achieveddate_rangeTime Frame:from date of randomization to end of treatment plus 30 daysenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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