drugset / Trial / NCT01687673
Phase II Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma
Phase 2
Completed
29 enrolled
University of California, San Francisco
Pfizer · collabRobert H. Lurie Cancer Center · collab
NaSingle-groupOpen-labelTreatment
Summary
This Phase II trial is being developed following the completion of a Phase I study of the combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced hepatocellular carcinoma (December 2009 through April 2012). The maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of temsirolimus is 10 mg IV weekly plus sorafenib 200 mg (oral, twice daily).
Timeline
- Start
- 2012-10-05
- Primary completion
- 2016-04-26
- Completion
- 2020-01-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sorafenib | Small molecule | 200 mg | Oral |
| Subject | Temsirolimus | Small molecule | 10 mg | Intravenous |