drugset / Trial / NCT02227914
Phase 1b/2 Study of Oprozomib in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of Phase 1b of the study is to determine the maximum tolerated dose, pharmacokinetics (PK) and pharmacodynamics (PDn) and assess the safety, tolerability and activity of oprozomib in combination with sorafenib in subjects with advanced hepatocellular carcinoma (HCC). The purpose of Phase 2 of the study is to evaluate the efficacy of oprozomib in combination with sorafenib versus sorafenib alone and to compare the key outcome measures for subjects with advanced HCC.
Timeline
- Start
- 2014-12
- Primary completion
- 2015-03
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oprozomib | Small molecule | 90 mg | — |
| Subject | Oprozomib | Small molecule | 120 mg | — |
| Subject | Oprozomib | Small molecule | 150 mg | — |
| Subject | Oprozomib | Small molecule | 180 mg | — |
| Subject | Oprozomib | Small molecule | 210 mg | — |
| Subject | Oprozomib | Small molecule | 240 mg | — |
| Subject | Sorafenib | Small molecule | 400 mg | — |
| Subject | Sorafenib | Small molecule | 600 mg | — |
| Subject | Sorafenib | Small molecule | 800 mg | — |