A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.
2 other identifiers
interventional
96
6 countries
28
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2005
Typical duration for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 21, 2005
CompletedFirst Posted
Study publicly available on registry
April 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
June 11, 2009
CompletedOctober 31, 2014
October 1, 2014
3 years
April 21, 2005
April 23, 2009
October 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Progression (TTP)
TTP was defined as the time from randomization to radiological disease progression by independent assessment.
from date of randomization of the first patient until 3 years later
Secondary Outcomes (7)
Overall Survival
from date of randomization of the first patient until 3 years later
Progression Free Survival (PFS)
from date of randomization of the first patient until 3 years later
Percentage of Participants in Each Category of Best Tumor Response
achieved during treatment or within 30 days after termination of active therapy
Time to Symptomatic Progression (TTSP)
from date of randomization of the first patient until 3 years later
Duration of Response
from date of randomization of the first patient until 3 years later
- +2 more secondary outcomes
Study Arms (2)
Sorafenib + Doxorubicin
EXPERIMENTAL"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Placebo + Doxorubicin
ACTIVE COMPARATOR"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Interventions
Multi kinase inhibitor plus Chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (28)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Beverly Hills, California, 90211-1850, United States
Unknown Facility
Orange, California, 92668-3298, United States
Unknown Facility
Palo Alto, California, 94304-1207, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
San Francisco, California, 94121, United States
Unknown Facility
Sylmar, California, 91342, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Lafayette, Louisiana, 70506, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Hackensack, New Jersey, 07601, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Seattle, Washington, 98101, United States
Unknown Facility
Buenos Aires, Ciudad Auton. de Buenos Aires, C1264AAA, Argentina
Unknown Facility
Neuquén, Neuquén Province, Q8300HDH, Argentina
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
Toronto, Ontario, M5G 2M9, Canada
Unknown Facility
Hong Kong, Hong Kong, Hong Kong
Unknown Facility
Kazan', 420111, Russia
Unknown Facility
Kirov, 610002, Russia
Unknown Facility
Krasnodar, 350040, Russia
Unknown Facility
Maidstone, Kent, ME16 9QQ, United Kingdom
Unknown Facility
London, London, W12 0HS, United Kingdom
Unknown Facility
Manchester, Manchester, M20 4BX, United Kingdom
Unknown Facility
Bebington, Merseyside, CH63 4JY, United Kingdom
Unknown Facility
Birmingham, West Midlands, B15 2TT, United Kingdom
Related Publications (2)
Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. doi: 10.1200/JCO.2005.01.3441. Epub 2006 Aug 14.
PMID: 16908937RESULTAbou-Alfa GK, Johnson P, Knox JJ, Capanu M, Davidenko I, Lacava J, Leung T, Gansukh B, Saltz LB. Doxorubicin plus sorafenib vs doxorubicin alone in patients with advanced hepatocellular carcinoma: a randomized trial. JAMA. 2010 Nov 17;304(19):2154-60. doi: 10.1001/jama.2010.1672.
PMID: 21081728RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study had been prematurely terminated by the sponsor because positive results were obtained in another Nexavar trial (Phase 3 study 100554 NCT00105443). NCI-CTC was translated to MedDRA for SOCs only.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2005
First Posted
April 22, 2005
Study Start
April 1, 2005
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
October 31, 2014
Results First Posted
June 11, 2009
Record last verified: 2014-10