drugset / Trial / NCT00657176
An Open-Label Phase-1 Study of OPB-31121 in Patients With Advanced Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, non-randomized, single-center, dose-escalation study in patients with advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned for the study. In this study, OPB-31121's potential for toxic effects will be evaluated in patients with advanced solid tumors to evaluate the recommended dose for use in subsequent studies. The pharmacokinetics and antitumor effect of the compound will also be investigated.
Timeline
- Start
- 2008-03
- Primary completion
- 2009-03
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OPB-31121 | Unknown | 100 mg | Oral |
| Subject | OPB-31121 | Unknown | 200 mg | Oral |
| Subject | OPB-31121 | Unknown | 400 mg | Oral |
| Subject | OPB-31121 | Unknown | 600 mg | Oral |
| Subject | OPB-31121 | Unknown | 800 mg | Oral |
| Subject | OPB-31121 | Unknown | 1000 mg | Oral |