A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
18 Years
N/A
Both
Carcinoma, Hepatocellular
Trial Information
A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
The following abbreviations were used in the Adverse Event section:
- international normalized ratio (inr)
- Common Terminology Criteria for Adverse Events (ctcae)
- Not Otherwise Specified (nos)
- Gastrointestinal (gi)
- Central nervous system (cns)
- Absolute Neutrophil Count (anc)
- Alanine aminotransferase (ALT)
- Aspartate aminotransferase (AST)
- Creatine phosphokinase (cpk)
- Gammaglutamyltransferase (ggt)
- Genitourinary (gu)
- Atrioventricular (av)
Inclusion Criteria:
- Ages eligible for study: 18 years and above, Genders eligible for study: both
- Patients who have a life expectancy of at least 12 weeks
- Patients with histologically or cytologically documented Hepatocellular Carcinoma
(HCC)
- Patients must have at least one tumor lesion that meets both of the following
criteria: (1) Accurately measured in at least one dimension according to RECIST
(Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local
therapy
- Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (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, superficial bladder
tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] &
T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated >
3 years prior to entry is permitted
- Renal failure requiring hemo- or peritoneal dialysis
- History of cardiac disease
- Active clinically serious infections
- Known history of human immunodeficiency virus (HIV) infection
- Known central nervous system tumors including metastatic brain disease
- Patients with clinically significant gastrointestinal bleeding within 30 days prior
to study entry
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS)
Outcome Description:
Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Outcome Time Frame:
from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
United States: Food and Drug Administration
Study ID:
100554
NCT ID:
NCT00105443
Start Date:
March 2005
Completion Date:
November 2008
Related Keywords:
- Carcinoma, Hepatocellular
- Liver Cancer
- Cancer
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Albany, Georgia 31701 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Omaha, Nebraska 68114 | |
| Eugene, Oregon |
