Phase 3
N=458
Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
Carcinoma, Hepatocellular
Bottom Line
View on ClinicalTrials.gov: NCT00494299 ↗Enrolled (actual)
458
Serious AEs
14.2%
Results posted
Jan 2011
Primary outcome: Primary: Time to Progression (TTP) — 164; 112 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sorafenib (Nexavar, BAY43-9006) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) |
164; 112 | — |
| SECONDARY Overall Survival (OS) |
— | — |
Summary
Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.
Eligibility Criteria
Inclusion Criteria
- Male or female
- Aged of 18 and over
- Advanced hepatocellular carcinoma
Exclusion Criteria
- History of prior systemic chemotherapy
- Failure in vital organ
Data sourced from ClinicalTrials.gov (NCT00494299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.