drugset / Trial / NCT00108953
A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2005-04
- Primary completion
- 2008-04
- Completion
- 2008-04
Outcome
Met primary endpoint
registry Sorafenib + Doxorubicin vs Placebo + Doxorubicin; p = 0.016; Hazard Ratio, log 0.6 (95% CI 0.33 to 0.95); Log Rank NCT00108953 ↗
Publications
- Results 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.
- Results Abou-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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Sorafenib | Small molecule | 200 mg | Oral |