drugset / Trial / NCT00971126
Study of Sorafenib With Combination of Thalidomide in Hepatocellular Carcinoma (HCC)
Phase 1/2
Terminated
3 enrolled
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital · collabNational Cheng-Kung University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this phase I study is to determine the maximal tolerable dose (MTD) of thalidomide (THADO®) in combination with fixed dose of sorafenib (NEXAVAR®) for the treatment of advanced or metastatic HCC. The Phase II purpose of this study is to determine the disease control rate (complete response + partial response + stable disease) for at least 4 months of sorafenib (NEXAVAR®) plus phase I determined MTD of thalidomide (THADO®) in patients with advanced or metastatic HCC.
Timeline
- Start
- 2009-07
- Primary completion
- 2010-01
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sorafenib | Small molecule | 400 mg | Oral |
| Subject | Thalidomide | Other / unclassified | 50 mg | Oral |
| Subject | Thalidomide | Other / unclassified | 100 mg | Oral |
| Subject | Thalidomide | Other / unclassified | 150 mg | Oral |
| Subject | Thalidomide | Other / unclassified | 200 mg | Oral |